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Trial record 38 of 69 for:    ORLISTAT

The Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes

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ClinicalTrials.gov Identifier: NCT00422058
Recruitment Status : Completed
First Posted : January 15, 2007
Results First Posted : October 28, 2010
Last Update Posted : November 1, 2017
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 Metabolism and Nutrition Disorder
Obesity
Interventions Drug: liraglutide
Drug: orlistat
Drug: placebo
Enrollment 564
Recruitment Details 19 sites in 8 countries: Denmark (3), Sweden (2), Finland (3), UK (3), Netherlands (1), Belgium (1), Spain (4) and Czech Republic (2)
Pre-assignment Details Between screening and randomisation, eligible subjects were included in a 2-week single-blind run-in period in which all subjects were placed on a hypocaloric diet. The dose of liraglutide and placebo was increased during the first 4 weeks after randomisation until maintenance dose was reached. Orlistat dose was fixed from randomisation.
Arm/Group Title Lira Placebo/Lira 2.4 mg/Lira 3.0 mg Lira 1.2 mg/Lira 3.0 mg Lira 1.8 mg/Lira 3.0 mg Lira 2.4 mg/Lira 3.0 mg Liraglutide 3.0 mg Orlistat
Hide Arm/Group Description Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
Period Title: Double-Blind, Week 0-20
Started 98 95 90 93 93 95
Completed 79 85 74 73 82 79
Not Completed 19 10 16 20 11 16
Reason Not Completed
Adverse Event             3             4             5             9             5             3
Protocol Violation             3             2             2             3             2             2
Lack of Efficacy             2             1             1             0             0             1
Other             11             3             8             8             4             10
Period Title: Open-Label Extension, Week 20-104
Started 79 85 74 73 82 79
Enrolled in Extension 67 68 59 65 72 67
Completed 47 46 38 45 47 45
Not Completed 32 39 36 28 35 34
Reason Not Completed
Not giving consent for extension             12             17             15             8             10             12
Adverse Event             3             4             7             4             4             0
Protocol Violation             1             2             3             1             5             3
Lack of Efficacy             3             2             5             2             0             1
Other             13             14             6             13             16             18
Arm/Group Title Lira Placebo/Lira 2.4 mg/Lira 3.0 mg Lira 1.2 mg/Lira 3.0 mg Lira 1.8 mg/Lira 3.0 mg Lira 2.4 mg/Lira 3.0 mg Liraglutide 3.0 mg Orlistat Total
Hide Arm/Group Description Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104) Total of all reporting groups
Overall Number of Baseline Participants 98 95 90 93 93 95 564
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 98 participants 95 participants 90 participants 93 participants 93 participants 95 participants 564 participants
45.86  (10.28) 47.18  (9.72) 45.53  (10.9) 45.01  (11.09) 45.91  (10.71) 45.94  (9.11) 45.91  (10.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 95 participants 90 participants 93 participants 93 participants 95 participants 564 participants
Female
74
  75.5%
73
  76.8%
68
  75.6%
71
  76.3%
70
  75.3%
73
  76.8%
429
  76.1%
Male
24
  24.5%
22
  23.2%
22
  24.4%
22
  23.7%
23
  24.7%
22
  23.2%
135
  23.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 98 participants 95 participants 90 participants 93 participants 93 participants 95 participants 564 participants
White 97 94 88 91 92 93 555
American Indian/Alaska Native 0 0 0 0 0 1 1
Black/African American 1 0 2 1 1 1 6
Other 0 1 0 1 0 0 2
BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 98 participants 95 participants 90 participants 93 participants 93 participants 95 participants 564 participants
34.9  (2.8) 34.8  (2.6) 35.0  (2.6) 35.0  (2.8) 34.8  (2.8) 34.1  (2.6) 34.8  (2.7)
[1]
Measure Description: BMI = Body Mass Index
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 98 participants 95 participants 90 participants 93 participants 93 participants 95 participants 564 participants
97.3  (12.3) 96.2  (13.5) 98.0  (12.5) 98.4  (13.0) 97.6  (13.7) 96.0  (11.7) 97.2  (12.8)
Waist circumference  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 98 participants 95 participants 90 participants 93 participants 93 participants 95 participants 564 participants
108.3  (10.0) 108.8  (10.4) 108.2  (9.5) 110.2  (10.7) 108.9  (8.3) 107.6  (9.7) 108.7  (9.8)
HbA1c   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage (%) of total haemoglobin
Number Analyzed 98 participants 95 participants 90 participants 93 participants 93 participants 95 participants 564 participants
5.60  (0.38) 5.58  (0.33) 5.60  (0.40) 5.54  (0.33) 5.57  (0.40) 5.55  (0.32) 5.60  (0.4)
[1]
Measure Description: HbA1c = glycosylated haemoglobin A1c
Blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 98 participants 95 participants 90 participants 93 participants 93 participants 95 participants 564 participants
Systolic 123.6  (11.1) 127.0  (13.1) 123.4  (13.0) 126.2  (13.9) 124.3  (11.3) 122.7  (13.5) 124.5  (12.7)
Diastolic 76.8  (8.5) 79.7  (9.1) 77.9  (7.9) 78.6  (8.2) 77.8  (8.3) 76.9  (7.9) 77.9  (8.4)
1.Primary Outcome
Title Mean Change From Baseline in Body Weight at Week 20
Hide Description Calculated as mean body weight at week 20 - baseline
Time Frame Week 0, week 20
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treat) analysis set using LOCF (last observation carried forward) is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product.
Arm/Group Title Lira Placebo/Lira 2.4 mg/Lira 3.0 mg Lira 1.2 mg/Lira 3.0 mg Lira 1.8 mg/Lira 3.0 mg Lira 2.4 mg/Lira 3.0 mg Liraglutide 3.0 mg Orlistat
Hide Arm/Group Description:
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
Overall Number of Participants Analyzed 98 94 90 92 92 95
Mean (Standard Deviation)
Unit of Measure: kg
Baseline 97.3  (12.3) 96.4  (13.4) 98.0  (12.5) 98.4  (13.1) 97.5  (13.8) 96.0  (11.7)
Change at Week 20 -3.0  (3.3) -5.1  (3.5) -5.9  (5.0) -6.6  (4.6) -7.6  (4.6) -4.4  (4.1)
2.Secondary Outcome
Title Mean Change From Baseline in Body Weight at Week 104
Hide Description Calculated as mean body weight at week 104 - baseline
Time Frame Week 0, week 104
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treat) analysis set using LOCF (last observation carried forward) is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product.
Arm/Group Title Lira Placebo/Lira 2.4 mg/Lira 3.0 mg Lira 1.2 mg/Lira 3.0 mg Lira 1.8 mg/Lira 3.0 mg Lira 2.4 mg/Lira 3.0 mg Liraglutide 3.0 mg Orlistat
Hide Arm/Group Description:
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
Overall Number of Participants Analyzed 98 94 90 92 92 95
Mean (Standard Deviation)
Unit of Measure: kg
Baseline 97.3  (12.3) 96.4  (13.4) 98.0  (12.5) 98.4  (13.1) 97.5  (13.8) 96.0  (11.7)
Change at Week 104 -5.4  (5.9) -4.9  (5.8) -5.6  (6.5) -6.4  (7.2) -8.2  (7.1) -3.8  (6.4)
3.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose at Week 20
Hide Description Calculated as mean fasting plasma glucose at week 20 - baseline
Time Frame Week 0, week 20
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product
Arm/Group Title Lira Placebo/Lira 2.4 mg/Lira 3.0 mg Lira 1.2 mg/Lira 3.0 mg Lira 1.8 mg/Lira 3.0 mg Lira 2.4 mg/Lira 3.0 mg Liraglutide 3.0 mg Orlistat
Hide Arm/Group Description:
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
Overall Number of Participants Analyzed 92 88 84 89 86 89
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline 5.42  (0.81) 5.30  (0.61) 5.29  (0.56) 5.27  (0.57) 5.36  (0.61) 5.3  (0.51)
Change at Week 20 -0.09  (0.54) -0.39  (0.45) -0.44  (0.63) -0.38  (0.48) -0.44  (0.44) -0.10  (0.41)
4.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose at Week 104
Hide Description Calculated as mean fasting plasma glucose at week 104 - baseline
Time Frame Week 0, week 104
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product
Arm/Group Title Lira Placebo/Lira 2.4 mg/Lira 3.0 mg Lira 1.2 mg/Lira 3.0 mg Lira 1.8 mg/Lira 3.0 mg Lira 2.4 mg/Lira 3.0 mg Liraglutide 3.0 mg Orlistat
Hide Arm/Group Description:
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
Overall Number of Participants Analyzed 92 88 84 89 86 89
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline 5.42  (0.81) 5.30  (0.61) 5.29  (0.56) 5.27  (0.57) 5.36  (0.61) 5.30  (0.51)
Change at Week 104 -0.22  (0.61) -0.09  (0.53) -0.09  (0.64) -0.20  (0.50) -0.23  (0.50) 0.02  (0.48)
5.Secondary Outcome
Title Change From Baseline in Fasting Insulin at Week 20
Hide Description Calculated as mean fasting insulin at week 20 - baseline
Time Frame Week 0, week 20
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Arm/Group Title Lira Placebo/Lira 2.4 mg/Lira 3.0 mg Lira 1.2 mg/Lira 3.0 mg Lira 1.8 mg/Lira 3.0 mg Lira 2.4 mg/Lira 3.0 mg Liraglutide 3.0 mg Orlistat
Hide Arm/Group Description:
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
Overall Number of Participants Analyzed 77 84 73 73 81 79
Mean (Standard Deviation)
Unit of Measure: pmol/L
Baseline 99.5  (129.2) 82.9  (43.0) 85.7  (49.5) 88.7  (43.3) 89.1  (51.9) 85.5  (48.3)
Change at Week 20 -15.0  (34.0) 8.7  (105.3) -0.7  (48.2) -3.9  (53.2) -12.3  (43.3) -16.7  (60.6)
6.Secondary Outcome
Title Change From Baseline in Fasting Insulin at Week 104
Hide Description Calculated as mean fasting insulin at week 104 - baseline
Time Frame Week 0, week 104
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Arm/Group Title Lira Placebo/Lira 2.4 mg/Lira 3.0 mg Lira 1.2 mg/Lira 3.0 mg Lira 1.8 mg/Lira 3.0 mg Lira 2.4 mg/Lira 3.0 mg Liraglutide 3.0 mg Orlistat
Hide Arm/Group Description:
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
Overall Number of Participants Analyzed 44 42 33 42 44 39
Mean (Standard Deviation)
Unit of Measure: pmol/L
Baseline 99.5  (129.2) 82.9  (43.0) 85.7  (49.5) 88.7  (43.3) 89.1  (51.9) 85.5  (48.3)
Change at Week 104 0.7  (53.6) -13.5  (39.7) 18.6  (102.6) -2.1  (47.3) -19.6  (44.3) -15.3  (39.8)
7.Secondary Outcome
Title Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20
Hide Description Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 20 - baseline
Time Frame Week 0, week 20
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Arm/Group Title Lira Placebo/Lira 2.4 mg/Lira 3.0 mg Lira 1.2 mg/Lira 3.0 mg Lira 1.8 mg/Lira 3.0 mg Lira 2.4 mg/Lira 3.0 mg Liraglutide 3.0 mg Orlistat
Hide Arm/Group Description:
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
Overall Number of Participants Analyzed 73 84 70 70 79 78
Mean (Standard Deviation)
Unit of Measure: percentage (%) of total haemoglobin
Baseline 5.60  (0.38) 5.58  (0.33) 5.60  (0.40) 5.54  (0.34) 5.57  (0.40) 5.55  (0.32)
Change at Week 20 0.01  (0.22) -0.14  (0.21) -0.21  (0.25) -0.22  (0.25) -0.24  (0.29) 0.00  (0.21)
8.Secondary Outcome
Title Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104
Hide Description Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 104 - baseline
Time Frame Week 0, week 104
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Arm/Group Title Lira Placebo/Lira 2.4 mg/Lira 3.0 mg Lira 1.2 mg/Lira 3.0 mg Lira 1.8 mg/Lira 3.0 mg Lira 2.4 mg/Lira 3.0 mg Liraglutide 3.0 mg Orlistat
Hide Arm/Group Description:
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
Overall Number of Participants Analyzed 46 45 36 45 47 45
Mean (Standard Deviation)
Unit of Measure: percentage (%) of total haemoglobin
Baseline 5.60  (0.38) 5.58  (0.33) 5.60  (0.40) 5.54  (0.34) 5.57  (0.40) 5.55  (0.32)
Change at Week 104 -0.32  (0.32) -0.25  (0.26) -0.30  (0.22) -0.25  (0.30) -0.35  (0.32) -0.18  (0.37)
9.Secondary Outcome
Title Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20
Hide Description Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 20-baseline. High hsCRP level is associated with greater cardiovascular risk
Time Frame Week 0, week 20
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Arm/Group Title Lira Placebo/Lira 2.4 mg/Lira 3.0 mg Lira 1.2 mg/Lira 3.0 mg Lira 1.8 mg/Lira 3.0 mg Lira 2.4 mg/Lira 3.0 mg Liraglutide 3.0 mg Orlistat
Hide Arm/Group Description:
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
Overall Number of Participants Analyzed 75 83 74 72 79 79
Mean (Standard Deviation)
Unit of Measure: mg/L
Baseline 3.6  (4.2) 5.1  (6.1) 4.4  (4.5) 4.0  (4.2) 3.8  (7.4) 4.6  (4.5)
Change at Week 20 0.8  (4.0) 0.1  (8.1) -0.8  (2.9) 0.5  (4.7) -1.1  (7.2) -0.3  (4.2)
10.Secondary Outcome
Title Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104
Hide Description Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 104- baseline. High hsCRP level is associated with greater cardiovascular risk
Time Frame Week 0, week 104
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Arm/Group Title Lira Placebo/Lira 2.4 mg/Lira 3.0 mg Lira 1.2 mg/Lira 3.0 mg Lira 1.8 mg/Lira 3.0 mg Lira 2.4 mg/Lira 3.0 mg Liraglutide 3.0 mg Orlistat
Hide Arm/Group Description:
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
Overall Number of Participants Analyzed 46 45 38 45 45 45
Mean (Standard Deviation)
Unit of Measure: mg/L
Baseline 3.6  (4.2) 5.1  (6.1) 4.4  (4.5) 4.0  (4.2) 3.8  (7.4) 4.6  (4.5)
Change at Week 104 -0.5  (2.6) -1.6  (6.0) -0.6  (8.6) -0.9  (3.2) -2.1  (9.3) 2.4  (19.4)
11.Secondary Outcome
Title Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20
Hide Description Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 20-baseline. High PAI-1 is associated with greater cardiovascular risk
Time Frame Week 0, week 20
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Arm/Group Title Lira Placebo/Lira 2.4 mg/Lira 3.0 mg Lira 1.2 mg/Lira 3.0 mg Lira 1.8 mg/Lira 3.0 mg Lira 2.4 mg/Lira 3.0 mg Liraglutide 3.0 mg Orlistat
Hide Arm/Group Description:
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
Overall Number of Participants Analyzed 68 69 61 60 72 65
Mean (Standard Deviation)
Unit of Measure: U/mL
Baseline 21.6  (9.3) 19.5  (9.9) 19.7  (9.8) 17.6  (8.7) 19.0  (9.1) 17.4  (8.2)
Change at Week 20 -3.0  (8.0) -2.0  (7.8) -3.5  (9.5) -2.3  (9.5) -4.5  (8.5) -1.2  (8.8)
12.Secondary Outcome
Title Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104
Hide Description Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 104-baseline. High PAI-1 is associated with greater cardiovascular risk
Time Frame Week 0, week 104
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Arm/Group Title Lira Placebo/Lira 2.4 mg/Lira 3.0 mg Lira 1.2 mg/Lira 3.0 mg Lira 1.8 mg/Lira 3.0 mg Lira 2.4 mg/Lira 3.0 mg Liraglutide 3.0 mg Orlistat
Hide Arm/Group Description:
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
Overall Number of Participants Analyzed 39 36 29 37 39 41
Mean (Standard Deviation)
Unit of Measure: U/mL
Baseline 21.6  (9.3) 19.5  (9.9) 19.7  (9.8) 17.6  (8.7) 19.0  (9.1) 17.4  (8.2)
Change at Week 104 -1.4  (7.0) -0.3  (9.1) -0.8  (9.8) 0.3  (9.9) 0.4  (10.9) 2.9  (7.4)
13.Secondary Outcome
Title Change From Baseline in Fibrinogen at Week 20
Hide Description Calculated as mean fibrinogen at week 20 - baseline. High fibrinogen is associated with greater cardiovascular risk
Time Frame Week 0, week 20
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Arm/Group Title Lira Placebo/Lira 2.4 mg/Lira 3.0 mg Lira 1.2 mg/Lira 3.0 mg Lira 1.8 mg/Lira 3.0 mg Lira 2.4 mg/Lira 3.0 mg Liraglutide 3.0 mg Orlistat
Hide Arm/Group Description:
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
Overall Number of Participants Analyzed 68 71 62 61 73 67
Mean (Standard Deviation)
Unit of Measure: g/L
Baseline 3.60  (0.67) 3.67  (0.76) 3.75  (0.72) 3.64  (0.72) 3.61  (0.68) 3.68  (0.82)
Change at Week 20 -0.06  (0.58) 0.01  (0.50) 0.02  (0.61) 0.10  (0.69) 0.05  (0.55) -0.12  (0.75)
14.Secondary Outcome
Title Change From Baseline in Fibrinogen at Week 104
Hide Description Calculated as mean fibrinogen at week 104 - baseline. High fibrinogen is associated with greater cardiovascular risk
Time Frame Week 0, week 104
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Arm/Group Title Lira Placebo/Lira 2.4 mg/Lira 3.0 mg Lira 1.2 mg/Lira 3.0 mg Lira 1.8 mg/Lira 3.0 mg Lira 2.4 mg/Lira 3.0 mg Liraglutide 3.0 mg Orlistat
Hide Arm/Group Description:
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
Overall Number of Participants Analyzed 39 38 29 36 39 41
Mean (Standard Deviation)
Unit of Measure: g/L
Baseline 3.60  (0.67) 3.67  (0.76) 3.75  (0.72) 3.64  (0.72) 3.61  (0.68) 3.68  (0.82)
Change at Week 104 -0.10  (0.74) -0.14  (0.73) -0.15  (0.98) -0.24  (0.74) -0.22  (0.82) -0.39  (1.24)
15.Secondary Outcome
Title Change From Baseline in Adiponectin at Week 20
Hide Description Calculated as mean adiponectin at week 20-baseline. A low adiponectin level is associated with greater cardiovascular risk
Time Frame Week 0, week 20
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Arm/Group Title Lira Placebo/Lira 2.4 mg/Lira 3.0 mg Lira 1.2 mg/Lira 3.0 mg Lira 1.8 mg/Lira 3.0 mg Lira 2.4 mg/Lira 3.0 mg Liraglutide 3.0 mg Orlistat
Hide Arm/Group Description:
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
Overall Number of Participants Analyzed 77 82 72 70 79 77
Mean (Standard Deviation)
Unit of Measure: mcg/mL
Baseline 5.1  (3.8) 5.8  (3.8) 6.7  (4.6) 6.2  (4.6) 6.1  (4.0) 5.4  (4.7)
Change at Week 20 2.3  (5.0) 1.2  (5.0) 1.7  (6.9) 1.6  (5.7) 2.3  (4.6) 1.7  (4.4)
16.Secondary Outcome
Title Change From Baseline in Adiponectin at Week 104
Hide Description Calculated as mean adiponectin at week 104-baseline. A low adiponectin level is associated with greater cardiovascular risk
Time Frame Week 0, week 104
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Arm/Group Title Lira Placebo/Lira 2.4 mg/Lira 3.0 mg Lira 1.2 mg/Lira 3.0 mg Lira 1.8 mg/Lira 3.0 mg Lira 2.4 mg/Lira 3.0 mg Liraglutide 3.0 mg Orlistat
Hide Arm/Group Description:
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
Overall Number of Participants Analyzed 39 36 27 39 35 39
Mean (Standard Deviation)
Unit of Measure: mcg/mL
Baseline 5.1  (3.8) 5.8  (3.8) 6.7  (4.6) 6.2  (4.6) 6.1  (4.0) 5.4  (4.7)
Change at Week 104 3.5  (4.4) 3.3  (3.8) 1.3  (3.9) 3.4  (5.4) 3.2  (4.1) 3.1  (4.2)
17.Secondary Outcome
Title Change From Baseline in Waist Circumference at Week 20
Hide Description Calculated as mean waist circumference at week 20-baseline.
Time Frame Week 0, week 20
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Arm/Group Title Lira Placebo/Lira 2.4 mg/Lira 3.0 mg Lira 1.2 mg/Lira 3.0 mg Lira 1.8 mg/Lira 3.0 mg Lira 2.4 mg/Lira 3.0 mg Liraglutide 3.0 mg Orlistat
Hide Arm/Group Description:
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
Overall Number of Participants Analyzed 90 93 83 85 85 87
Mean (Standard Deviation)
Unit of Measure: cm
Baseline 108.3  (10.0) 109.0  (10.3) 108.2  (9.5) 110.4  (10.6) 108.7  (8.3) 107.6  (9.7)
Change at Week 20 -4.2  (4.7) -5.8  (6.1) -5.9  (5.3) -7.2  (5.8) -7.9  (5.5) -6.0  (5.4)
18.Secondary Outcome
Title Change From Baseline in Waist Circumference at Week 104
Hide Description Calculated as mean waist circumference at week 104-baseline.
Time Frame Week 0, week 104
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Arm/Group Title Lira Placebo/Lira 2.4 mg/Lira 3.0 mg Lira 1.2 mg/Lira 3.0 mg Lira 1.8 mg/Lira 3.0 mg Lira 2.4 mg/Lira 3.0 mg Liraglutide 3.0 mg Orlistat
Hide Arm/Group Description:
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
Overall Number of Participants Analyzed 47 46 38 45 47 45
Mean (Standard Deviation)
Unit of Measure: cm
Baseline 108.3  (10.0) 109.0  (10.3) 108.2  (9.5) 110.4  (10.6) 108.7  (8.3) 107.6  (9.7)
Change at Week 104 -10.0  (7.2) -8.6  (7.5) -9.0  (8.7) -10.4  (7.8) -9.8  (7.5) -9.5  (7.3)
19.Secondary Outcome
Title Change From Baseline in Blood Pressure at Week 20
Hide Description Calculated as mean blood pressure at week 20-baseline.
Time Frame Week 0, week 20
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product
Arm/Group Title Lira Placebo/Lira 2.4 mg/Lira 3.0 mg Lira 1.2 mg/Lira 3.0 mg Lira 1.8 mg/Lira 3.0 mg Lira 2.4 mg/Lira 3.0 mg Liraglutide 3.0 mg Orlistat
Hide Arm/Group Description:
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
Overall Number of Participants Analyzed 94 88 85 89 89 90
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline (Systolic ) 123.6  (11.1) 127.2  (13.1) 123.4  (13.0) 126.3  (13.9) 124.3  (11.3) 122.7  (13.5)
Change at Week 20 (Systolic) -3.2  (13.3) -6.1  (11.1) -4.8  (12.7) -9.1  (12.3) -6.4  (10.0) -4.3  (10.9)
Baseline (Diastolic) 76.78  (8.50) 79.71  (9.12) 77.91  (7.92) 78.53  (8.23) 77.84  (8.38) 76.94  (7.94)
Change at Week 20 (Diastolic) -0.32  (7.52) -1.53  (9.15) -1.61  (8.04) -1.39  (7.79) -2.37  (7.71) -1.96  (7.82)
20.Secondary Outcome
Title Change From Baseline in Blood Pressure at Week 104
Hide Description Calculated as mean blood pressure at week 104-baseline.
Time Frame Week 0, week 104
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product
Arm/Group Title Lira Placebo/Lira 2.4 mg/Lira 3.0 mg Lira 1.2 mg/Lira 3.0 mg Lira 1.8 mg/Lira 3.0 mg Lira 2.4 mg/Lira 3.0 mg Liraglutide 3.0 mg Orlistat
Hide Arm/Group Description:
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
Overall Number of Participants Analyzed 94 88 85 89 89 90
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline (Systolic ) 123.6  (11.1) 127.2  (13.1) 123.4  (13.0) 126.3  (13.9) 124.3  (11.3) 122.7  (13.5)
Change at Week 104 (Systolic) -2.0  (13.8) -4.0  (13.4) -3.8  (16.0) -6.5  (12.6) -5.6  (11.7) -2.0  (11.7)
Baseline (Diastolic) 76.78  (8.50) 79.71  (9.12) 77.91  (7.92) 78.53  (8.23) 77.84  (8.38) 76.94  (7.94)
Change at Week 104 (Diastolic) 1.64  (8.47) -0.98  (9.81) -1.00  (9.37) -1.99  (9.61) -1.92  (9.41) -1.11  (8.36)
Time Frame The adverse events were collected over 104 weeks.
Adverse Event Reporting Description Safety analysis set consists of all subjects exposed to trial product(s).
 
Arm/Group Title Lira Placebo/Lira 2.4 mg/Lira 3.0 mg Lira 1.2 mg/Lira 3.0 mg Lira 1.8 mg/Lira 3.0 mg Lira 2.4 mg/Lira 3.0 mg Liraglutide 3.0 mg Orlistat
Hide Arm/Group Description Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
All-Cause Mortality
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg Lira 1.2 mg/Lira 3.0 mg Lira 1.8 mg/Lira 3.0 mg Lira 2.4 mg/Lira 3.0 mg Liraglutide 3.0 mg Orlistat
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg Lira 1.2 mg/Lira 3.0 mg Lira 1.8 mg/Lira 3.0 mg Lira 2.4 mg/Lira 3.0 mg Liraglutide 3.0 mg Orlistat
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/98 (6.12%)      9/95 (9.47%)      10/90 (11.11%)      7/93 (7.53%)      10/93 (10.75%)      6/95 (6.32%)    
Cardiac disorders             
Atrial fibrillation  1  1/98 (1.02%)  1 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Bundle branch block left  1  0/98 (0.00%)  0 0/95 (0.00%)  0 1/90 (1.11%)  1 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Congenital, familial and genetic disorders             
Thyroglossal cyst  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 1/93 (1.08%)  1 0/93 (0.00%)  0 0/95 (0.00%)  0
Ear and labyrinth disorders             
Vestibular neuronitis  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 1/93 (1.08%)  1 0/95 (0.00%)  0
Eye disorders             
Retinal detachment  1  0/98 (0.00%)  0 0/95 (0.00%)  0 1/90 (1.11%)  1 1/93 (1.08%)  1 0/93 (0.00%)  0 0/95 (0.00%)  0
Gastrointestinal disorders             
Abdominal pain  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 2/93 (2.15%)  2 1/95 (1.05%)  1
Abdominal pain upper  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 1/93 (1.08%)  1 0/93 (0.00%)  0 0/95 (0.00%)  0
Colitis ulcerative  1  0/98 (0.00%)  0 1/95 (1.05%)  1 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Hernial eventration  1  0/98 (0.00%)  0 0/95 (0.00%)  0 1/90 (1.11%)  1 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Pancreatitis acute  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 1/93 (1.08%)  1 0/95 (0.00%)  0
Vomiting  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 1/93 (1.08%)  1 1/93 (1.08%)  1 0/95 (0.00%)  0
General disorders             
Non-cardiac chest pain  1  0/98 (0.00%)  0 0/95 (0.00%)  0 1/90 (1.11%)  1 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Hepatobiliary disorders             
Cholecystitis  1  1/98 (1.02%)  1 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Cholecystitis acute  1  0/98 (0.00%)  0 0/95 (0.00%)  0 1/90 (1.11%)  1 0/93 (0.00%)  0 1/93 (1.08%)  1 0/95 (0.00%)  0
Cholelithiasis  1  0/98 (0.00%)  0 1/95 (1.05%)  1 1/90 (1.11%)  1 0/93 (0.00%)  0 1/93 (1.08%)  1 1/95 (1.05%)  1
Immune system disorders             
Anaphylactic reaction  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 1/93 (1.08%)  1 0/95 (0.00%)  0
Infections and infestations             
Abscess limb  1  1/98 (1.02%)  1 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Appendicitis  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 1/93 (1.08%)  1 0/93 (0.00%)  0 1/95 (1.05%)  1
Cellulitis  1  1/98 (1.02%)  1 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Diverticulitis  1  0/98 (0.00%)  0 1/95 (1.05%)  1 1/90 (1.11%)  1 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Gastroenteritis  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 1/93 (1.08%)  1 0/95 (0.00%)  0
Post procedural infection  1  0/98 (0.00%)  0 0/95 (0.00%)  0 1/90 (1.11%)  1 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Pyelonephritis acute  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 1/93 (1.08%)  1 0/95 (0.00%)  0
Injury, poisoning and procedural complications             
Anaesthetic complication  1  0/98 (0.00%)  0 1/95 (1.05%)  1 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Clavicle fracture  1  0/98 (0.00%)  0 1/95 (1.05%)  1 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Foreign body trauma  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 1/93 (1.08%)  1 0/93 (0.00%)  0 0/95 (0.00%)  0
Multiple injuries  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 1/95 (1.05%)  1
Skin laceration  1  1/98 (1.02%)  1 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Tibia fracture  1  1/98 (1.02%)  1 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Metabolism and nutrition disorders             
Hyperglycaemia  1  0/98 (0.00%)  0 1/95 (1.05%)  1 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Back pain  1  0/98 (0.00%)  0 1/95 (1.05%)  1 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Ligament calcification  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 1/93 (1.08%)  1 0/93 (0.00%)  0 0/95 (0.00%)  0
Musculoskeletal chest pain  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 1/93 (1.08%)  1 0/95 (0.00%)  0
Osteoarthritis  1  0/98 (0.00%)  0 1/95 (1.05%)  1 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Adenocarcinoma  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 1/93 (1.08%)  1 0/93 (0.00%)  0 0/95 (0.00%)  0
Breast cancer  1  0/98 (0.00%)  0 0/95 (0.00%)  0 1/90 (1.11%)  1 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Prostate cancer  1  0/98 (0.00%)  0 0/95 (0.00%)  0 1/90 (1.11%)  1 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Uterine leiomyoma  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 1/93 (1.08%)  1 0/93 (0.00%)  0 0/95 (0.00%)  0
Nervous system disorders             
Cerebrovascular accident  1  0/98 (0.00%)  0 0/95 (0.00%)  0 1/90 (1.11%)  1 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Transient ischaemic attack  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 1/93 (1.08%)  1 0/95 (0.00%)  0
Renal and urinary disorders             
Nephrolithiasis  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 1/93 (1.08%)  1 0/95 (0.00%)  0
Stress urinary incontinence  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 1/93 (1.08%)  1 0/93 (0.00%)  0 0/95 (0.00%)  0
Reproductive system and breast disorders             
Ovarian cyst  1  0/98 (0.00%)  0 1/95 (1.05%)  1 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Ovarian cyst ruptured  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 1/95 (1.05%)  1
Respiratory, thoracic and mediastinal disorders             
Dyspnoea  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 1/93 (1.08%)  1 0/95 (0.00%)  0
Vascular disorders             
Hypertension  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 1/95 (1.05%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 10.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg Lira 1.2 mg/Lira 3.0 mg Lira 1.8 mg/Lira 3.0 mg Lira 2.4 mg/Lira 3.0 mg Liraglutide 3.0 mg Orlistat
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   90/98 (91.84%)      90/95 (94.74%)      86/90 (95.56%)      89/93 (95.70%)      90/93 (96.77%)      89/95 (93.68%)    
Cardiac disorders             
Palpitations  1  0/98 (0.00%)  0 0/95 (0.00%)  0 6/90 (6.67%)  6 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Ear and labyrinth disorders             
Vertigo  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 5/95 (5.26%)  5
Gastrointestinal disorders             
Abdominal distension  1  5/98 (5.10%)  5 5/95 (5.26%)  5 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Abdominal pain  1  6/98 (6.12%)  6 0/95 (0.00%)  0 6/90 (6.67%)  6 0/93 (0.00%)  0 0/93 (0.00%)  0 7/95 (7.37%)  10
Abdominal pain upper  1  5/98 (5.10%)  6 6/95 (6.32%)  9 0/90 (0.00%)  0 5/93 (5.38%)  6 7/93 (7.53%)  9 8/95 (8.42%)  10
Constipation  1  15/98 (15.31%)  19 20/95 (21.05%)  24 12/90 (13.33%)  14 22/93 (23.66%)  29 19/93 (20.43%)  23 7/95 (7.37%)  9
Diarrhoea  1  20/98 (20.41%)  27 15/95 (15.79%)  23 16/90 (17.78%)  21 18/93 (19.35%)  20 18/93 (19.35%)  21 33/95 (34.74%)  49
Dry mouth  1  0/98 (0.00%)  0 6/95 (6.32%)  7 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Dyspepsia  1  10/98 (10.20%)  12 9/95 (9.47%)  10 9/90 (10.00%)  9 10/93 (10.75%)  19 10/93 (10.75%)  10 5/95 (5.26%)  6
Eructation  1  0/98 (0.00%)  0 0/95 (0.00%)  0 5/90 (5.56%)  5 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Flatulence  1  0/98 (0.00%)  0 0/95 (0.00%)  0 6/90 (6.67%)  6 0/93 (0.00%)  0 0/93 (0.00%)  0 12/95 (12.63%)  13
Nausea  1  29/98 (29.59%)  40 35/95 (36.84%)  47 34/90 (37.78%)  40 39/93 (41.94%)  61 47/93 (50.54%)  76 8/95 (8.42%)  9
Steatorrhoea  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 5/95 (5.26%)  5
Toothache  1  0/98 (0.00%)  0 0/95 (0.00%)  0 7/90 (7.78%)  9 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Vomiting  1  6/98 (6.12%)  7 12/95 (12.63%)  15 13/90 (14.44%)  24 16/93 (17.20%)  20 13/93 (13.98%)  16 0/95 (0.00%)  0
General disorders             
Fatigue  1  8/98 (8.16%)  9 7/95 (7.37%)  7 8/90 (8.89%)  8 8/93 (8.60%)  8 13/93 (13.98%)  13 0/95 (0.00%)  0
Oedema peripheral  1  6/98 (6.12%)  7 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Infections and infestations             
Bronchitis  1  0/98 (0.00%)  0 0/95 (0.00%)  0 7/90 (7.78%)  7 5/93 (5.38%)  6 0/93 (0.00%)  0 6/95 (6.32%)  6
Cystitis  1  6/98 (6.12%)  6 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Gastroenteritis  1  13/98 (13.27%)  13 13/95 (13.68%)  16 20/90 (22.22%)  31 15/93 (16.13%)  19 21/93 (22.58%)  26 20/95 (21.05%)  24
Gastroenteritis viral  1  5/98 (5.10%)  5 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Influenza  1  10/98 (10.20%)  16 24/95 (25.26%)  37 11/90 (12.22%)  17 17/93 (18.28%)  23 22/93 (23.66%)  39 25/95 (26.32%)  39
Nasopharyngitis  1  41/98 (41.84%)  85 37/95 (38.95%)  69 34/90 (37.78%)  71 42/93 (45.16%)  80 38/93 (40.86%)  74 26/95 (27.37%)  46
Pharyngitis  1  5/98 (5.10%)  6 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Pneumonia  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 5/93 (5.38%)  5 0/93 (0.00%)  0 0/95 (0.00%)  0
Sinusitis  1  0/98 (0.00%)  0 8/95 (8.42%)  13 8/90 (8.89%)  10 8/93 (8.60%)  11 5/93 (5.38%)  10 6/95 (6.32%)  7
Tooth infection  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 5/95 (5.26%)  6
Upper Respiratory Tract Infection  1  9/98 (9.18%)  13 10/95 (10.53%)  11 8/90 (8.89%)  16 12/93 (12.90%)  13 13/93 (13.98%)  20 13/95 (13.68%)  16
Urinary Tract Infection  1  5/98 (5.10%)  8 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 5/95 (5.26%)  6
Injury, poisoning and procedural complications             
Joint sprain  1  5/98 (5.10%)  7 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 7/95 (7.37%)  8
Investigations             
Blood insulin increased  1  0/98 (0.00%)  0 5/95 (5.26%)  5 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Blood TSH increased  1  0/98 (0.00%)  0 0/95 (0.00%)  0 5/90 (5.56%)  7 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Metabolism and nutrition disorders             
Hyperglycaemia  1  5/98 (5.10%)  5 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Arthralgia  1  14/98 (14.29%)  15 9/95 (9.47%)  10 0/90 (0.00%)  0 10/93 (10.75%)  12 5/93 (5.38%)  5 7/95 (7.37%)  9
Back pain  1  14/98 (14.29%)  15 9/95 (9.47%)  10 16/90 (17.78%)  20 16/93 (17.20%)  17 12/93 (12.90%)  18 16/95 (16.84%)  21
Muscle spasms  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 5/95 (5.26%)  5
Musculoskeletal discomfort  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 5/93 (5.38%)  9 0/93 (0.00%)  0 0/95 (0.00%)  0
Musculoskeletal pain  1  6/98 (6.12%)  6 0/95 (0.00%)  0 0/90 (0.00%)  0 7/93 (7.53%)  9 0/93 (0.00%)  0 0/95 (0.00%)  0
Pain in extremity  1  9/98 (9.18%)  10 5/95 (5.26%)  7 9/90 (10.00%)  9 6/93 (6.45%)  6 7/93 (7.53%)  8 6/95 (6.32%)  6
Nervous system disorders             
Dizziness  1  12/98 (12.24%)  12 7/95 (7.37%)  8 6/90 (6.67%)  8 6/93 (6.45%)  8 9/93 (9.68%)  9 0/95 (0.00%)  0
Headache  1  23/98 (23.47%)  37 23/95 (24.21%)  41 16/90 (17.78%)  23 23/93 (24.73%)  54 22/93 (23.66%)  25 16/95 (16.84%)  26
Psychiatric disorders             
Insomnia  1  0/98 (0.00%)  0 0/95 (0.00%)  0 0/90 (0.00%)  0 0/93 (0.00%)  0 7/93 (7.53%)  8 0/95 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Cough  1  8/98 (8.16%)  8 7/95 (7.37%)  8 0/90 (0.00%)  0 0/93 (0.00%)  0 0/93 (0.00%)  0 6/95 (6.32%)  6
Oropharyngeal pain  1  0/98 (0.00%)  0 5/95 (5.26%)  5 0/90 (0.00%)  0 0/93 (0.00%)  0 7/93 (7.53%)  7 9/95 (9.47%)  10
Skin and subcutaneous tissue disorders             
Rash  1  0/98 (0.00%)  0 0/95 (0.00%)  0 7/90 (7.78%)  7 0/93 (0.00%)  0 0/93 (0.00%)  0 0/95 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 10.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Novo Nordisk acknowledges the Investigator’s right to publish the entire results of the trial. Any such scientific paper, presentation, communication or other information concerning the investigation described in this protocol, must be submitted in writing to Novo Nordisk’s Trial Manager prior to submission for publication/presentation for comments. Comments will be given within four weeks from receipt of the manuscript.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
EMail: clinicaltrials@novonordisk.com
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00422058     History of Changes
Obsolete Identifiers: NCT00480909
Other Study ID Numbers: NN8022-1807
2006-004481-13 ( EudraCT Number )
First Submitted: January 12, 2007
First Posted: January 15, 2007
Results First Submitted: April 27, 2010
Results First Posted: October 28, 2010
Last Update Posted: November 1, 2017