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Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.

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ClinicalTrials.gov Identifier: NCT02970942
Recruitment Status : Completed
First Posted : November 22, 2016
Results First Posted : April 21, 2021
Last Update Posted : November 16, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Hepatobiliary Disorders
Non-alcoholic Steatohepatitis
Interventions Drug: Semaglutide
Drug: Placebo
Enrollment 320
Recruitment Details The trial was conducted at 114 sites in 16 countries as follows (number of sites that screened participants/ number of sites that randomised participants): Australia (4/ 3); Austria (3/ 3); Belgium (4/ 4); Bulgaria (2/ 2); Canada (9/ 7); Denmark (2/ 2); Finland (1/ 1); France (8/ 6); Greece (5/ 5); Japan (13/ 12); Netherlands (7/ 5); Russian Federation (25/ 17); Spain (6/ 5); Sweden (3/ 2); United Kingdom (15/ 11); United States (36/ 29).
Pre-assignment Details Participants were randomised in a 3:3:3:1:1:1 ratio to receive once-daily semaglutide or placebo subcutaneously. After randomisation, the participants entered a dose-escalation period, with increase in dose every 4 weeks until the target dose was reached.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72). Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72). Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72). Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Period Title: Overall Study
Started 80 78 82 80
Full Analysis Set 80 78 82 80
Safety Analysis Set 80 78 81 80
Exposed 80 78 81 80
Completed 76 72 77 77
Not Completed 4 6 5 3
Reason Not Completed
Death             0             1             0             0
Lost to Follow-up             1             0             2             1
Withdrawal by Subject             3             5             3             2
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo Total
Hide Arm/Group Description Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72). Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72). Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72). Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks. Total of all reporting groups
Overall Number of Baseline Participants 80 78 82 80 320
Hide Baseline Analysis Population Description
The full analysis set included all randomised participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants 78 participants 82 participants 80 participants 320 participants
55.2  (10.9) 58.1  (9.9) 54.3  (10.2) 52.4  (10.8) 55.0  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 78 participants 82 participants 80 participants 320 participants
Female
51
  63.7%
52
  66.7%
47
  57.3%
44
  55.0%
194
  60.6%
Male
29
  36.3%
26
  33.3%
35
  42.7%
36
  45.0%
126
  39.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 78 participants 82 participants 80 participants 320 participants
Hispanic or Latino
7
   8.8%
10
  12.8%
14
  17.1%
9
  11.3%
40
  12.5%
Not Hispanic or Latino
69
  86.3%
63
  80.8%
65
  79.3%
66
  82.5%
263
  82.2%
Unknown or Not Reported
4
   5.0%
5
   6.4%
3
   3.7%
5
   6.3%
17
   5.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 78 participants 82 participants 80 participants 320 participants
American Indian or Alaska Native
0
   0.0%
1
   1.3%
2
   2.4%
0
   0.0%
3
   0.9%
Asian
10
  12.5%
12
  15.4%
14
  17.1%
12
  15.0%
48
  15.0%
Black or African American
1
   1.3%
1
   1.3%
0
   0.0%
0
   0.0%
2
   0.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
65
  81.3%
59
  75.6%
62
  75.6%
62
  77.5%
248
  77.5%
Other
0
   0.0%
0
   0.0%
1
   1.2%
1
   1.3%
2
   0.6%
Not applicable
4
   5.0%
5
   6.4%
3
   3.7%
5
   6.3%
17
   5.3%
1.Primary Outcome
Title Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No)
Hide Description NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1 and hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning ranges from 0-2; lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Endpoint was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame After 72 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with fibrosis stage 2 or 3 at baseline who contributed to the analysis. In below table, 'Yes' infers percentage of participants who achieved NASH resolution without worsening of fibrosis and 'No' infers vice-versa; 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 57 59 56 58
Measure Type: Number
Unit of Measure: Percentage of participants
Yes 40.4 35.6 58.9 17.2
No 54.4 47.5 30.4 74.1
Missing 5.3 16.9 10.7 8.6
2.Secondary Outcome
Title Percentage of Participants With at Least One Stage of Liver Fibrosis Improvement With no Worsening of NASH After 72 Weeks (Yes/No)
Hide Description NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1; hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning range: 0-2; lobular inflammation range: 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, higher scores indicate greater fibrosis (0=None, 4=Cirrhosis). Endpoint was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (Week 79); 2) withdrawal of consent; 3)last contact with participant (for participants lost to follow-up); 4)death.
Time Frame After 72 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with fibrosis stage 2 or 3 at baseline who contributed to the analysis. In below table, 'Yes' infers percentage of participants who achieved at least one stage of fibrosis improvement with no worsening of NASH; 'No' infers vice-versa; 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 57 59 56 58
Measure Type: Number
Unit of Measure: Percentage of participants
Yes 49.1 32.2 42.9 32.8
No 45.6 50.8 46.4 58.6
Missing 5.3 16.9 10.7 8.6
3.Secondary Outcome
Title Percentage of Participants With Change in Total NAFLD (Non- Alcoholic Fatty Liver Disease) Activity Score (NAS)
Hide Description Percentage of participants who had worsened, improved or had no change in total NAS from baseline to week 72 is presented. Worsening is defined as an increase of at least 1 in the NAS; Improvement is defined as a decrease of at least 1 in the NAS; while no change corresponds to no change in NAS from baseline to week 72. NAS is calculated as the sum of scores for steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocyte ballooning (0 to 2). Therefore, it is assessed on a scale of 0-8, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 80 78 82 80
Measure Type: Number
Unit of Measure: Percentage of participants
Improvement 71.3 79.5 82.9 43.8
Worsening 7.5 2.6 3.7 16.3
No change 13.8 5.1 1.2 27.5
Missing 7.5 12.8 12.2 12.5
4.Secondary Outcome
Title Percentage of Participants With Change in Steatosis
Hide Description Percentage of participants who had improved, worsened, or had no change in steatosis from baseline to week 72 is presented. Steatosis was assessed on a scale of 0-3, with higher scores indicating more severe steatosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 80 78 82 80
Measure Type: Number
Unit of Measure: Percentage of participants
Improvement 52.5 60.3 63.4 26.3
Worsening 6.3 2.6 3.7 15.0
No change 33.8 24.4 20.7 46.3
Missing 7.5 12.8 12.2 12.5
5.Secondary Outcome
Title Percentage of Participants With Change in Lobular Inflammation
Hide Description Percentage of participants who had improved, worsened, or had no change in lobular inflammation from baseline to week 72 is presented. Lobular inflammation was assessed on a scale of 0-3, with higher scores indicating more severe lobular inflammation. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 80 78 82 80
Measure Type: Number
Unit of Measure: Percentage of participants
Improvement 41.3 47.4 37.8 26.3
Worsening 7.5 7.7 6.1 17.5
No change 43.8 32.1 43.9 45.0
Missing 7.5 12.8 12.2 11.3
6.Secondary Outcome
Title Percentage of Participants With Change in Hepatocyte Ballooning
Hide Description Percentage of participants who had improved, worsened, or had no change in hepatocyte ballooning from baseline to week 72 is presented. Hepatocyte ballooning was assessed on a scale of 0-2, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 80 78 82 80
Measure Type: Number
Unit of Measure: Percentage of participants
Improvement 61.3 70.5 74.4 38.8
Worsening 2.5 2.6 1.2 2.5
No change 28.8 14.1 12.2 46.3
Missing 7.5 12.8 12.2 12.5
7.Secondary Outcome
Title Percentage of Participants With Change in Fibrosis Stage According to the Kleiner Fibrosis Classification
Hide Description Percentage of participants who had improved, worsened, or had no change in fibrosis stage from baseline to week 72 is presented. The degree of fibrosis is described by the Kleiner fibrosis staging system, ranging from F0 (absence of fibrosis), F1 (portal/perisinusoidal fibrosis), F2 (perisinusoidal and portal/periportal fibrosis), F3 (septal or bridging fibrosis) through F4 (cirrhosis). The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 80 78 82 80
Measure Type: Number
Unit of Measure: Percentage of participants
Improvement 46.3 32.1 42.7 31.3
Worsening 10.0 7.7 4.9 18.8
No change 36.3 42.3 36.6 37.5
Missing 7.5 17.9 15.9 12.5
8.Secondary Outcome
Title Percentage of Participants With Change in Activity Component of Steatosis-activity-fibrosis (SAF) Score
Hide Description Percentage of participants who had improved, worsened, or had no change in the activity component of the SAF score from baseline to week 72 is presented. SAF score was assessed on a scale of 0-4, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 80 78 82 80
Measure Type: Number
Unit of Measure: Percentage of participants
Improvement 62.5 71.8 72.0 42.5
Worsening 7.5 3.8 1.2 11.3
No change 22.5 11.5 14.6 33.8
Missing 7.5 12.8 12.2 12.5
9.Secondary Outcome
Title Change in Fibrosis-4 Score
Hide Description Change in fibrosis-4 score is presented as ratio to baseline. Fibrosis-4 is the ratio of age in years and aminotransferase to platelet count. It is a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, alanine aminotransferase (ALT), AST and age that is calculated using formula: Fibrosis-4 = (Age [years] x AST [U/L]) / (platelets [10^9/L] x (square root of ALT [U/L])). A Fibrosis-4 index of < 1.45 indicated no or moderate fibrosis and an index of > 3.25 indicated extensive fibrosis/cirrhosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 71 63 72 67
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of fibrosis-4 score
0.81
(36.8%)
0.77
(32.4%)
0.77
(31.3%)
0.95
(43.1%)
10.Secondary Outcome
Title Change in NAFLD Fibrosis Score (NFS)
Hide Description Change in NFS from baseline to week 72 is presented. NFS is calculated using formula: NFS = -1.675 + 0.037 * age (years) + 0.094 * body mass index (BMI) (kg/m^2) + 1.13 * hyperglycaemia (yes/no) + 0.99 * Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) ratio + 0.013 × platelet count (*10^9/L) - 0.66 * albumin (g/dL). The score is used to classify the probability of fibrosis. A score a) < -1.5 indicates a low probability, b) > -1.5 to < 0.67 indicates intermediate probability, and a score of c) > 0.67 indicates a high probability of liver fibrosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 71 63 72 66
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-0.322  (0.819) -0.617  (0.691) -0.475  (0.770) -0.040  (0.844)
11.Secondary Outcome
Title Change in Alanine Aminotransferase (ALT)
Hide Description Change in ALT (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 76 71 77 75
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of ALT
0.62
(62.7%)
0.57
(62.1%)
0.40
(68.2%)
0.80
(60.3%)
12.Secondary Outcome
Title Change in Aspartate Aminotransferase (AST)
Hide Description Change in AST (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 74 69 77 74
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of AST
0.66
(55.1%)
0.63
(46.6%)
0.50
(45.8%)
0.84
(62.3%)
13.Secondary Outcome
Title Change in Gamma Glutamyl Transferase (GGT)
Hide Description Change in GGT (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 76 71 77 75
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of GGT
0.76
(52.0%)
0.64
(51.6%)
0.48
(60.2%)
0.92
(46.6%)
14.Secondary Outcome
Title Change in Albumin
Hide Description Change in albumin (measured as grams per deciliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 76 71 77 75
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of albumin
1.02
(5.6%)
1.01
(6.0%)
1.01
(5.4%)
1.02
(6.0%)
15.Secondary Outcome
Title Change in International Normalized Ratio (INR)
Hide Description Change in INR is presented as ratio to baseline. INR is the ratio of measured prothrombin time over normal prothrombin time and it evaluates the extrinsic coagulation pathway (vitamin K dependent clotting factors II; V, VII, IX and X). These clotting factors are synthesised in the liver, thus INR is used as a marker of liver synthesis function. The therapeutic INR range varies, most commonly an INR 2-3 goal, but ranging from 1.5-4.0. Bleeding complications are more likely to occur above an INR value of 4.0. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 76 71 76 75
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of INR
0.97
(18.8%)
0.96
(11.8%)
0.93
(22.3%)
0.99
(19.3%)
16.Secondary Outcome
Title Change in Enhanced Liver Fibrosis (ELF)
Hide Description Change in ELF from baseline to week 72 is presented. The ELF discriminant score was derived as a log-linear combination of the markers hyaluronic acid (HA), amino-terminal propeptide of type III collagen (PIIINP) and tissue inhibitor of metalloproteinase 1 (TIMP1). ELF score = -7.412 + 0.681 × ln(HA (nanograms per millilitre (ng/mL)) + 0.775 × ln(P3NP (ng/mL)) + 0.494 × ln(TIMP1 (ng/mL)). ELF score: a) < 7.7: no to mild fibrosis; b) ≥ 7.7 - < 9.8: Moderate fibrosis; c) ≥ 9.8 - < 11.3: Severe fibrosis; d) ≥ 11.3: Cirrhosis. A negative change from baseline indicates decreased fibrosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 76 70 76 75
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.4  (0.7) -0.4  (0.8) -0.6  (0.8) 0.1  (0.7)
17.Secondary Outcome
Title Change in Cytokeratin 18 (CK-18) Fragments
Hide Description Change in CK-18 fragments (M30, M65) (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 76 71 76 74
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of CK-18 fragments
M30
0.52
(84.2%)
0.50
(76.4%)
0.40
(74.5%)
0.78
(106.9%)
M65
0.51
(73.1%)
0.52
(62.5%)
0.38
(65.6%)
0.71
(83.7%)
18.Secondary Outcome
Title Change in microRNA 122 (miR-122)
Hide Description Change in miR-122 (measured as 1/microliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants.Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 73 71 76 74
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of miR-122
0.86
(151.8%)
0.74
(203.1%)
0.58
(161.3%)
1.28
(194.3%)
19.Secondary Outcome
Title Change in Interleukin-1 Receptor (IL-1R) Antagonist
Hide Description Change in interleukin-1 receptor (IL-1R) antagonist (measured as picograms per milliliter) antagonist is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 69 65 74 69
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of IL-1R antagonist
0.87
(49.3%)
0.85
(37.5%)
0.73
(47.9%)
0.94
(41.7%)
20.Secondary Outcome
Title Change in Monocyte Chemoattractant Protein 1 (MCP-1)
Hide Description Change in MCP-1 (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 75 71 76 73
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of MCP-1
1.07
(23.3%)
1.08
(29.8%)
0.99
(30.7%)
1.04
(26.4%)
21.Secondary Outcome
Title Change in Fibroblast Growth Factor 21 (FGF-21)
Hide Description Change in FGF-21 (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 76 71 77 74
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of FGF-21
0.72
(86.1%)
0.61
(104.1%)
0.55
(91.3%)
0.76
(64.8%)
22.Secondary Outcome
Title Change in Liver Stiffness Assessed by FibroScan®
Hide Description Change in liver stiffness (measured as kilopascal (kPa)) assessed by FibroScan® is presented as ratio to baseline. FibroScan® is a specialized ultrasound machine for the liver. It measures fibrosis (scarring) by measuring the stiffness of the liver. It's normally between 2 and 6 kPa. Many people with liver disease(s) have a result that's higher than the normal range. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 47 49 46 45
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of liver stiffness
0.72
(49.3%)
0.64
(52.2%)
0.66
(58.4%)
1.18
(71.2%)
23.Secondary Outcome
Title Change in Liver Steatosis Assessed by FibroScan®
Hide Description Change in liver steatosis assessed by FibroScan® from baseline to week 72 is presented. FibroScan® is a specialized ultrasound machine for the liver. It measures fibrosis (scarring) and steatosis (fatty change) in the liver. Fatty change is fat building up in the liver cells. To assess liver steatosis, the controlled attenuation parameter (CAP; giving an estimate of ultrasound attenuation ∼3.5 MegaHertz (MHz)) is available with the M probe of the FibroScan. The CAP score is measured in decibels per meter (dB/m). It ranges from 100 to 400 dB/m, with higher scores indicating higher amount of liver with fatty change. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 34 37 33 35
Mean (Standard Deviation)
Unit of Measure: Decibels per meter
-5.8  (41.1) -50.9  (64.3) -42.1  (73.3) -18.7  (43.3)
24.Secondary Outcome
Title Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 72 Weeks (Yes/No)
Hide Description Percentage of participants with weight loss of greater than or equal to (≥) 5% of baseline body weight at 72 weeks is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. In the below table, 'Yes' infers percentage of participants who have achieved ≥ 5% weight loss; 'No' infers percentage of participants who have not achieved ≥ 5% weight loss at 72 weeks and 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).
Time Frame Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 80 78 82 80
Measure Type: Number
Unit of Measure: Percentage of participants
Yes 43.8 62.8 76.8 16.3
No 51.3 28.2 17.1 78.8
Missing 5.0 9.0 6.1 5.0
25.Secondary Outcome
Title Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 72 Weeks (Yes/No)
Hide Description Pentage of participants with weight loss of ≥ 10% of baseline body weight at 72 weeks is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. In the below table, 'Yes' infers percentage of participants who have achieved ≥ 10% weight loss; 'No' infers percentage of participants who have not achieved ≥ 10% weight loss at 72 weeks and 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).
Time Frame Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 80 78 82 80
Measure Type: Number
Unit of Measure: Percentage of participants
Yes 17.5 38.5 59.8 2.5
No 77.5 52.6 34.1 92.5
Missing 5.0 9.0 6.1 5.0
26.Secondary Outcome
Title Change in Body Weight
Hide Description Change in body weight from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 76 71 77 76
Mean (Standard Deviation)
Unit of Measure: Kilograms
-4.8  (6.0) -9.4  (9.2) -12.3  (8.6) -1.0  (4.9)
27.Secondary Outcome
Title Change in Waist Circumference
Hide Description Change in waist circumference from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 76 69 77 75
Mean (Standard Deviation)
Unit of Measure: Centimeters
-3.9  (6.3) -7.1  (8.9) -11.4  (9.3) -1.7  (6.2)
28.Secondary Outcome
Title Change in Body Mass Index (BMI)
Hide Description Change in BMI from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants.Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 76 71 77 76
Mean (Standard Deviation)
Unit of Measure: Kilograms per square meter
-1.8  (2.2) -3.5  (3.4) -4.6  (3.3) -0.3  (1.8)
29.Secondary Outcome
Title Change in Glycosylated Haemoglobin (HbA1c) (%-Point)
Hide Description Change in HbA1c (measured as percentage point of HbA1c) from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 46 45 47 47
Mean (Standard Deviation)
Unit of Measure: Percentage point of HbA1c
-0.7  (1.1) -1.2  (0.9) -1.2  (1.0) -0.0  (1.0)
30.Secondary Outcome
Title Change in HbA1c (Millimoles Per Mole)
Hide Description Change in HbA1c from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 46 45 47 47
Mean (Standard Deviation)
Unit of Measure: millimoles per mole
-7.9  (12.2) -12.8  (9.5) -12.8  (11.3) -0.3  (10.7)
31.Secondary Outcome
Title Change in Fasting Plasma Glucose (FPG)
Hide Description Change in FPG from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 45 44 47 48
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter
-1.39  (2.53) -2.17  (1.82) -2.09  (2.68) -0.34  (2.72)
32.Secondary Outcome
Title Change in Fasting Glucagon
Hide Description Change in fasting glucagon (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 45 45 47 47
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of glucagon
0.78
(76.8%)
0.65
(94.8%)
0.63
(100.4%)
1.04
(80.8%)
33.Secondary Outcome
Title Change in Homeostatic Model Assessment - Insulin Resistance (HOMA-IR)
Hide Description Change in HOMA-IR is presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting plasma glucose [mmol/L] x fasting insulin [mmol/L]/ 22.5. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants.Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 42 43 44 45
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of HOMA-IR
0.77
(62.2%)
0.60
(77.6%)
0.58
(94.6%)
0.81
(127.5%)
34.Secondary Outcome
Title Change in Diastolic Blood Pressure (DBP)
Hide Description Blood pressure was measured in a sitting position after 5 minutes of rest. Change in DBP from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants.Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 76 70 77 76
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury
0  (10) -2  (11) -2  (9) -1  (10)
35.Secondary Outcome
Title Change in Systolic Blood Pressure (SBP)
Hide Description Blood pressure was measured in a sitting position after 5 minutes of rest. Change in SBP from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 76 70 77 76
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury
-2  (16) -7  (18) -6  (16) -2  (15)
36.Secondary Outcome
Title Change in Total Cholesterol
Hide Description Change in total cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants.Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 75 68 77 75
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of total cholesterol
0.98
(17.1%)
1.00
(20.3%)
0.93
(15.7%)
0.93
(18.8%)
37.Secondary Outcome
Title Change in Low Density Lipoprotein (LDL) Cholesterol
Hide Description Change in LDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 73 68 77 75
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of LDL cholesterol
0.96
(22.9%)
1.01
(34.9%)
0.92
(25.5%)
0.90
(30.7%)
38.Secondary Outcome
Title Change in High Density Lipoprotein (HDL) Cholesterol
Hide Description Change in HDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 74 68 77 75
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of HDL cholesterol
1.04
(16.1%)
1.05
(12.9%)
1.09
(16.4%)
1.01
(12.9%)
39.Secondary Outcome
Title Change in Very Low Density Lipoprotein (VLDL) Cholesterol
Hide Description Change in VLDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 73 68 77 75
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of VLDL cholesterol
0.89
(31.9%)
0.90
(36.1%)
0.74
(38.2%)
0.93
(36.7%)
40.Secondary Outcome
Title Change in Triglycerides
Hide Description Change in triglycerides (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 74 68 77 75
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of triglycerides
0.88
(34.1%)
0.89
(37.6%)
0.73
(41.4%)
0.95
(36.9%)
41.Secondary Outcome
Title Change in Free Fatty Acids
Hide Description Change in free fatty acids (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 72 68 74 72
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of free fatty acids
0.83
(54.8%)
0.92
(73.2%)
0.72
(80.8%)
1.05
(75.9%)
42.Secondary Outcome
Title Change in High Sensitivity C-reactive Protein (hsCRP)
Hide Description Change in hsCRP (measured as milligram per liter) from baseline to week 72 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 76 71 77 75
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of hsCRP
0.78
(114.6%)
0.50
(124.1%)
0.41
(114.6%)
0.91
(85.8%)
43.Secondary Outcome
Title Change in Short Form 36 (SF-36) Score
Hide Description Change in SF-36 score from baseline to week 72 is presented. SF-36 measures participant's overall health related quality of life (HRQoL). It is a 36-item generic measure of health status and yields 2 summary scores for physical health and mental health, and 8 domain scores (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional, mental health). The scores 0-100 (where higher scores indicates a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of scores in the 2009 U.S. general population. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 80 78 82 80
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Mental component sum Number Analyzed 76 participants 68 participants 77 participants 74 participants
2.2  (8.5) 0.6  (9.2) 1.2  (9.5) -0.4  (8.9)
Physical component sum Number Analyzed 76 participants 68 participants 76 participants 74 participants
2.1  (7.0) 1.1  (7.3) 3.9  (7.1) -0.1  (8.3)
Physical functioning Number Analyzed 76 participants 70 participants 76 participants 75 participants
1.8  (7.8) 2.0  (7.3) 2.8  (7.8) -0.4  (8.2)
Role functioning Number Analyzed 76 participants 69 participants 77 participants 74 participants
2.1  (6.9) 0.5  (9.3) 2.2  (8.1) -0.3  (9.4)
Bodily pain Number Analyzed 76 participants 70 participants 77 participants 75 participants
1.3  (10.9) 1.2  (10.1) 3.4  (7.9) -1.3  (10.2)
General health Number Analyzed 76 participants 70 participants 77 participants 75 participants
7.2  (14.8) 2.3  (17.8) 9.0  (17.4) 4.3  (16.5)
Vitality Number Analyzed 76 participants 69 participants 77 participants 75 participants
2.3  (8.6) 0.6  (9.4) 4.6  (9.8) -0.2  (10.1)
Social functioning Number Analyzed 76 participants 70 participants 77 participants 75 participants
3.7  (9.0) -0.1  (9.9) 2.2  (9.4) -1.6  (8.3)
Role emotional Number Analyzed 76 participants 68 participants 77 participants 74 participants
2.2  (8.9) 0.6  (9.1) 0.5  (9.5) -0.3  (8.5)
Mental health Number Analyzed 76 participants 69 participants 77 participants 75 participants
1.2  (8.9) 1.5  (8.2) 1.3  (9.5) -0.2  (9.7)
44.Secondary Outcome
Title Number of Treatment-emergent Adverse Events (TEAEs)
Hide Description An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half lives of semaglutide); 2) end of the in-trial period.
Time Frame From week 0 to week 79
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 80 78 81 80
Measure Type: Number
Unit of Measure: events
525 577 511 445
45.Secondary Outcome
Title Number of Treatment-emergent Hypoglycaemic Episodes
Hide Description Hypoglycaemic episode (blood glucose less than or equal to (<=) 3.9 mmol/L (70 mg/dL) Or greater than (>) 3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms) is defined as treatment emergent if the onset of the episode occurs during the on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame From week 0 to week 79
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 49 51 49 50
Measure Type: Number
Unit of Measure: episodes
54 30 66 18
46.Secondary Outcome
Title Number of Treatment-emergent Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemic Episodes
Hide Description Severe or BG confirmed symptomatic hypoglycaemia: episode, severe as per american diabetes association (ADA) classification or BG confirmed by plasma glucose value < 3.1 mmol/L(56mg/dL) with symptoms along with hypoglycaemia. Severe hypoglycaemia: episode requiring assistance of other person to actively administer carbohydrate, glucagon, or take corrective actions. Plasma glucose concentrations may not be available during event, but neurological recovery following return of plasma glucose to normal is sufficient evidence that event was induced by low plasma glucose concentration. Hypoglycaemic episode is treatment emergent if onset of it occurs during on-treatment period: period starting on day of first administration of trial product and ending on day of last dose of trial product+7 days; except for evaluation of AEs; hypoglycaemic episodes for which period ended on date of whatever came first:last dose of trial product + 49 days (7 half-lives of semaglutide); end of in-trial period.
Time Frame From week 0 to week 79
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 49 51 49 50
Measure Type: Number
Unit of Measure: episodes
3 5 17 2
47.Secondary Outcome
Title Number of Treatment-emergent Severe Hypoglycaemic Episodes
Hide Description Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Hypoglycaemic episode is defined as treatment emergent if the onset of the episode occurs during the on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame From week 0 to week 79
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 49 51 49 50
Measure Type: Number
Unit of Measure: episodes
2 2 0 0
48.Secondary Outcome
Title Number of Participants Discontinuing Treatment Due to Gastrointestinal Adverse Events
Hide Description Number of participants discontinuing treatment due to gastrointestinal adverse events is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame From week 0 to week 79
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 80 78 81 80
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.3%
6
   7.7%
2
   2.5%
0
   0.0%
49.Secondary Outcome
Title Number of Participants With Occurrence of Anti-semaglutide Antibodies During and After 72 Weeks Treatment (Yes/No)
Hide Description Number of participants with occurrence of anti-semaglutide antibodies during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with occurrence of anti-semaglutide antibodies and 'No' infers number of participants without anti-semaglutide antibodies during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame From week 0 to week 79
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Overall Number of Participants Analyzed 80 78 81
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
4
   5.0%
1
   1.3%
2
   2.5%
No
76
  95.0%
77
  98.7%
79
  97.5%
50.Secondary Outcome
Title Number of Participants With Anti-semaglutide Antibodies With in Vitro Neutralising Effect During and After 72 Weeks Treatment (Yes/No)
Hide Description Number of participants with anti-semaglutide antibodies with in vitro neutralising effect during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with anti-semaglutide antibodies with in vitro neutralising effect and 'No' infers number of participants without anti-semaglutide antibodies with in vitro neutralising effect during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame From week 0 to week 79
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Overall Number of Participants Analyzed 80 78 81
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
0
   0.0%
0
   0.0%
0
   0.0%
No
80
 100.0%
78
 100.0%
81
 100.0%
51.Secondary Outcome
Title Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 During and After 72 Weeks Treatment (Yes/No)
Hide Description Number of participants with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with anti-semaglutide antibodies cross reacting with native GLP-1 and 'No' infers number of participants without anti-semaglutide antibodies cross reacting with native GLP-1 during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame From week 0 to week 79
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Overall Number of Participants Analyzed 80 78 81
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
4
   5.0%
0
   0.0%
2
   2.5%
No
76
  95.0%
78
 100.0%
79
  97.5%
52.Secondary Outcome
Title Number of Participants With Cross-reacting Anti-semaglutide Binding Antibodies With in Vitro Neutralising Effect to Native GLP-1 During and After 72 Weeks Treatment (Yes/No)
Hide Description Number of participants with cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 and 'No' infers number of participants without cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Time Frame From week 0 to week 79
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Overall Number of Participants Analyzed 80 78 81
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
0
   0.0%
0
   0.0%
0
   0.0%
No
80
 100.0%
78
 100.0%
81
 100.0%
53.Secondary Outcome
Title Change in Pulse From Baseline to Week 72
Hide Description Change in pulse from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 73 63 72 71
Mean (Standard Deviation)
Unit of Measure: beats per minute (bpm)
2.2  (10.9) 2.1  (9.0) 0.9  (9.6) -0.3  (9.1)
54.Secondary Outcome
Title Percentage of Participants With Change in Electrocardiogram (ECG)
Hide Description A 12-lead ECG was performed at baseline (week 0) and week 72 and categorised as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS). Percentage of participants in each ECG category at week 0 and week 72 are presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 80 78 81 80
Measure Type: Number
Unit of Measure: Percentage of participants
Week 0: Normal Number Analyzed 80 participants 78 participants 81 participants 80 participants
58.8 60.3 66.7 63.8
Week 0: Abnormal NCS Number Analyzed 80 participants 78 participants 81 participants 80 participants
41.3 39.7 32.1 36.3
Week 0: Abnormal CS Number Analyzed 80 participants 78 participants 81 participants 80 participants
0.0 0.0 1.2 0.0
Week 72: Normal Number Analyzed 74 participants 63 participants 71 participants 70 participants
64.9 65.1 74.6 60.0
Week 72: Abnormal NCS Number Analyzed 74 participants 63 participants 71 participants 70 participants
35.1 34.9 23.9 38.6
Week 72: Abnormal CS Number Analyzed 74 participants 63 participants 71 participants 70 participants
0.0 0.0 1.4 1.4
55.Secondary Outcome
Title Percentage of Participants With Change in Physical Examination: Cardiovascular System
Hide Description Percentage of participants with change in physical examination (cardiovascular system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame Week -6, week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 80 78 81 80
Measure Type: Number
Unit of Measure: Percentage of participants
Week -6: Normal Number Analyzed 80 participants 78 participants 81 participants 80 participants
87.5 93.6 92.6 92.5
Week -6: Abnormal NCS Number Analyzed 80 participants 78 participants 81 participants 80 participants
11.3 5.1 7.4 6.3
Week -6: Abnormal CS Number Analyzed 80 participants 78 participants 81 participants 80 participants
1.3 1.3 0.0 1.3
Week 72: Normal Number Analyzed 74 participants 64 participants 72 participants 71 participants
87.8 96.9 94.4 90.1
Week 72: Abnormal NCS Number Analyzed 74 participants 64 participants 72 participants 71 participants
12.2 3.1 5.6 8.5
Week 72: Abnormal CS Number Analyzed 74 participants 64 participants 72 participants 71 participants
0.0 0.0 0.0 1.4
56.Secondary Outcome
Title Percentage of Participants With Change in Physical Examination: Central and Peripheral Nervous System
Hide Description Percentage of participants with change in physical examination (central and peripheral nervous system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame Week -6, week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 80 77 79 80
Measure Type: Number
Unit of Measure: Percentage of participants
Week -6: Normal Number Analyzed 80 participants 77 participants 79 participants 80 participants
92.5 94.8 98.7 95.0
Week -6: Abnormal NCS Number Analyzed 80 participants 77 participants 79 participants 80 participants
5.0 5.2 1.3 3.8
Week -6: Abnormal CS Number Analyzed 80 participants 77 participants 79 participants 80 participants
2.5 0.0 0.0 1.3
Week 72: Normal Number Analyzed 74 participants 63 participants 69 participants 70 participants
94.6 93.7 98.6 92.9
Week 72: Abnormal NCS Number Analyzed 74 participants 63 participants 69 participants 70 participants
5.4 4.8 1.4 7.1
Week 72: Abnormal CS Number Analyzed 74 participants 63 participants 69 participants 70 participants
0.0 1.6 0.0 0.0
57.Secondary Outcome
Title Percentage of Participants With Change in Physical Examination: Gastrointestinal System Including Mouth
Hide Description Percentage of participants with change in physical examination (gastrointestinal system including mouth) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame Week -6, week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 80 77 81 80
Measure Type: Number
Unit of Measure: Percentage of participants
Week -6: Normal Number Analyzed 80 participants 77 participants 81 participants 80 participants
82.5 83.1 84.0 86.3
Week -6: Abnormal NCS Number Analyzed 80 participants 77 participants 81 participants 80 participants
13.8 15.6 16.0 12.5
Week -6: Abnormal CS Number Analyzed 80 participants 77 participants 81 participants 80 participants
3.8 1.3 0.0 1.3
Week 72: Normal Number Analyzed 74 participants 63 participants 72 participants 71 participants
89.2 81.0 87.5 84.5
Week 72: Abnormal NCS Number Analyzed 74 participants 63 participants 72 participants 71 participants
10.8 19.0 12.5 14.1
Week 72: Abnormal CS Number Analyzed 74 participants 63 participants 72 participants 71 participants
0.0 0.0 0.0 1.4
58.Secondary Outcome
Title Percentage of Participants With Change in Physical Examination: General Appearance
Hide Description Percentage of participants with change in physical examination (general appearance) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame Week -6, week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 80 78 81 80
Measure Type: Number
Unit of Measure: Percentage of participants
Week -6: Normal Number Analyzed 80 participants 78 participants 81 participants 80 participants
83.8 85.9 79.0 80.0
Week -6: Abnormal NCS Number Analyzed 80 participants 78 participants 81 participants 80 participants
16.3 12.8 21.0 20.0
Week -6: Abnormal CS Number Analyzed 80 participants 78 participants 81 participants 80 participants
0.0 1.3 0.0 0.0
Week 72: Normal Number Analyzed 74 participants 64 participants 72 participants 71 participants
83.8 90.6 90.3 76.1
Week 72: Abnormal NCS Number Analyzed 74 participants 64 participants 72 participants 71 participants
16.2 6.3 9.7 23.9
Week 72: Abnormal CS Number Analyzed 74 participants 64 participants 72 participants 71 participants
0.0 3.1 0.0 0.0
59.Secondary Outcome
Title Percentage of Participants With Change in Physical Examination: Head, Ears, Eyes, Nose, Throat, Neck
Hide Description Percentage of participants with change in physical examination (head, ears, eyes, nose, throat, neck) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame Week -6, week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 80 77 80 80
Measure Type: Number
Unit of Measure: Percentage of participants
Week -6: Normal Number Analyzed 80 participants 77 participants 80 participants 80 participants
97.5 94.8 98.8 97.5
Week -6: Abnormal NCS Number Analyzed 80 participants 77 participants 80 participants 80 participants
2.5 5.2 1.3 2.5
Week -6: Abnormal CS Number Analyzed 80 participants 77 participants 80 participants 80 participants
0.0 0.0 0.0 0.0
Week 72: Normal Number Analyzed 73 participants 62 participants 70 participants 71 participants
94.5 96.8 98.6 98.6
Week 72: Abnormal NCS Number Analyzed 73 participants 62 participants 70 participants 71 participants
4.1 3.2 1.4 0.0
Week 72: Abnormal CS Number Analyzed 73 participants 62 participants 70 participants 71 participants
1.4 0.0 0.0 1.4
60.Secondary Outcome
Title Percentage of Participants With Change in Physical Examination: Lymph Node Palpation
Hide Description Percentage of participants with change in physical examination (lymph node palpation) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame Week -6, week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 80 77 78 80
Measure Type: Number
Unit of Measure: Percentage of participants
Week -6: Normal Number Analyzed 80 participants 77 participants 78 participants 80 participants
100.0 98.7 100.0 100.0
Week -6: Abnormal NCS Number Analyzed 80 participants 77 participants 78 participants 80 participants
0.0 1.3 0.0 0.0
Week -6: Abnormal CS Number Analyzed 80 participants 77 participants 78 participants 80 participants
0.0 0.0 0.0 0.0
Week 72: Normal Number Analyzed 74 participants 60 participants 70 participants 71 participants
100.0 100.0 100.0 100.0
Week 72: Abnormal NCS Number Analyzed 74 participants 60 participants 70 participants 71 participants
0.0 0.0 0.0 0.0
Week 72: Abnormal CS Number Analyzed 74 participants 60 participants 70 participants 71 participants
0.0 0.0 0.0 0.0
61.Secondary Outcome
Title Percentage of Participants With Change in Physical Examination: Musculoskeletal System
Hide Description Percentage of participants with change in physical examination (musculoskeletal system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame Week -6, week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 80 77 79 80
Measure Type: Number
Unit of Measure: Percentage of participants
Week -6: Normal Number Analyzed 80 participants 77 participants 79 participants 80 participants
95.0 96.1 94.9 95.0
Week -6: Abnormal NCS Number Analyzed 80 participants 77 participants 79 participants 80 participants
3.8 3.9 5.1 3.8
Week -6: Abnormal CS Number Analyzed 80 participants 77 participants 79 participants 80 participants
1.3 0.0 0.0 1.3
Week 72: Normal Number Analyzed 74 participants 63 participants 70 participants 71 participants
94.6 96.8 100.0 95.8
Week 72: Abnormal NCS Number Analyzed 74 participants 63 participants 70 participants 71 participants
5.4 3.2 0.0 4.2
Week 72: Abnormal CS Number Analyzed 74 participants 63 participants 70 participants 71 participants
0.0 0.0 0.0 0.0
62.Secondary Outcome
Title Percentage of Participants With Change in Physical Examination: Respiratory System
Hide Description Percentage of participants with change in physical examination (respiratory system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame Week -6, week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 80 78 81 80
Measure Type: Number
Unit of Measure: Percentage of participants
Week -6: Normal Number Analyzed 80 participants 78 participants 81 participants 80 participants
100.0 100.0 100.0 97.5
Week -6: Abnormal NCS Number Analyzed 80 participants 78 participants 81 participants 80 participants
0.0 0.0 0.0 2.5
Week -6: Abnormal CS Number Analyzed 80 participants 78 participants 81 participants 80 participants
0.0 0.0 0.0 0.0
Week 72: Normal Number Analyzed 74 participants 64 participants 72 participants 71 participants
98.6 96.9 98.6 98.6
Week 72: Abnormal NCS Number Analyzed 74 participants 64 participants 72 participants 71 participants
0.0 3.1 1.4 1.4
Week 72: Abnormal CS Number Analyzed 74 participants 64 participants 72 participants 71 participants
1.4 0.0 0.0 0.0
63.Secondary Outcome
Title Percentage of Participants With Change in Physical Examination: Skin
Hide Description Percentage of participants with change in physical examination (skin) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame Week -6, week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 80 78 81 80
Measure Type: Number
Unit of Measure: Percentage of participants
Week -6: Normal Number Analyzed 80 participants 78 participants 81 participants 80 participants
96.3 92.3 85.2 90.0
Week -6: Abnormal NCS Number Analyzed 80 participants 78 participants 81 participants 80 participants
2.5 6.4 13.6 10.0
Week -6: Abnormal CS Number Analyzed 80 participants 78 participants 81 participants 80 participants
1.3 1.3 1.2 0.0
Week 72: Normal Number Analyzed 74 participants 64 participants 70 participants 71 participants
94.6 87.5 90.0 88.7
Week 72: Abnormal NCS Number Analyzed 74 participants 64 participants 70 participants 71 participants
4.1 10.9 8.6 11.3
Week 72: Abnormal CS Number Analyzed 74 participants 64 participants 70 participants 71 participants
1.4 1.6 1.4 0.0
64.Secondary Outcome
Title Percentage of Participants With Change in Physical Examination: Thyroid Gland
Hide Description Percentage of participants with change in physical examination (thyroid gland) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame Week -6, week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 80 77 80 80
Measure Type: Number
Unit of Measure: Percentage of participants
Week -6: Normal Number Analyzed 80 participants 77 participants 80 participants 80 participants
88.8 97.4 97.5 98.8
Week -6: Abnormal NCS Number Analyzed 80 participants 77 participants 80 participants 80 participants
10.0 2.6 2.5 0.0
Week -6: Abnormal CS Number Analyzed 80 participants 77 participants 80 participants 80 participants
1.3 0.0 0.0 1.3
Week 72: Normal Number Analyzed 74 participants 62 participants 70 participants 70 participants
94.6 98.4 97.1 98.6
Week 72: Abnormal NCS Number Analyzed 74 participants 62 participants 70 participants 70 participants
5.4 1.6 2.9 1.4
Week 72: Abnormal CS Number Analyzed 74 participants 62 participants 70 participants 70 participants
0.0 0.0 0.0 0.0
65.Secondary Outcome
Title Change in Haematocrit
Hide Description Change in haematocrit from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 71 59 70 68
Mean (Standard Deviation)
Unit of Measure: Percentage of haematocrit in blood
-0.79  (3.14) -0.71  (2.77) -1.43  (3.50) -0.41  (3.53)
66.Secondary Outcome
Title Change in Haemoglobin (g/dL)
Hide Description Change in haemoglobin from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 71 59 70 68
Mean (Standard Deviation)
Unit of Measure: Grams per deciliter (g/dL)
0.18  (1.05) 0.08  (0.89) -0.07  (0.98) 0.21  (1.08)
67.Secondary Outcome
Title Change in Haemoglobin (mmol/L)
Hide Description Change in haemoglobin from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 71 59 70 68
Mean (Standard Deviation)
Unit of Measure: millimoles per liter (mmol/L)
0.11  (0.65) 0.05  (0.55) -0.05  (0.61) 0.13  (0.67)
68.Secondary Outcome
Title Change in Leukocytes
Hide Description Change in leukocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 71 59 70 68
Mean (Standard Deviation)
Unit of Measure: 10^9 cells per liter (10^9/L)
0.489  (1.564) 0.260  (1.343) -0.047  (1.532) 0.075  (1.733)
69.Secondary Outcome
Title Change in Thrombocytes
Hide Description Change in thrombocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 71 59 69 67
Mean (Standard Deviation)
Unit of Measure: 10^9 cells per liter (10^9/L)
8.8  (46.9) 14.6  (34.8) 9.0  (44.9) 0.3  (43.7)
70.Secondary Outcome
Title Change in Erythrocytes
Hide Description Change in erythrocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 71 59 70 68
Mean (Standard Deviation)
Unit of Measure: 10^12 cells per liter (10^12/L)
0.038  (0.292) 0.004  (0.220) -0.034  (0.334) 0.054  (0.314)
71.Secondary Outcome
Title Change in Creatinine (mg/dL)
Hide Description Change in creatinine (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 74 62 72 70
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of creatinine
1.018
(30.70%)
1.069
(42.19%)
1.026
(35.17%)
1.021
(33.87%)
72.Secondary Outcome
Title Change in Creatinine (Umol/L)
Hide Description Change in creatinine (measured as micro mole per liter (umol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 74 62 72 70
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of creatinine
1.018
(30.70%)
1.069
(42.19%)
1.026
(35.17%)
1.021
(33.87%)
73.Secondary Outcome
Title Change in Estimated Glomerular Filtration Rate (eGFR)
Hide Description Change in eGFR (measured as milliliter/minute/1.732 meter square (mL/min/1.73 m^2)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 74 62 72 70
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of eGFR
0.976
(28.04%)
0.940
(40.47%)
0.973
(31.42%)
0.969
(31.24%)
74.Secondary Outcome
Title Change in Creatine Kinase
Hide Description Change in creatine kinase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 74 62 72 70
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of creatine kinase
0.975
(73.02%)
0.798
(77.96%)
0.825
(74.17%)
0.904
(76.04%)
75.Secondary Outcome
Title Change in Urea
Hide Description Change in urea (measured as milli mole per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 74 62 72 70
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of urea
1.018
(51.01%)
0.973
(52.30%)
1.042
(51.14%)
1.043
(52.30%)
76.Secondary Outcome
Title Change in Total Bilirubin (mg/dL)
Hide Description Change in total bilirubin (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).
Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).
Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.
Overall Number of Participants Analyzed 74 62 72 70
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of total bilirubin
0.978
(66.72%)
1.011
(70.66%)
0.949
(65.89%)
1.040
(67.36%)
77.Secondary Outcome
Title Change in Total Bilirubin (Umol/L)
Hide Description Change in total bilirubin (measured as micromole per liter (umol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Time Frame Baseline (week 0), Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
Arm/Group Title Semaglutide 0.1 mg Semaglutide 0.2 mg Semaglutide 0.4 mg Placebo
Hide Arm/Group Description:
Participants wer