Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program (STEP 3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03611582
Recruitment Status : Completed
First Posted : August 2, 2018
Results First Posted : July 9, 2021
Last Update Posted : November 11, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE July 17, 2018
First Posted Date  ICMJE August 2, 2018
Results First Submitted Date  ICMJE June 16, 2021
Results First Posted Date  ICMJE July 9, 2021
Last Update Posted Date November 11, 2021
Actual Study Start Date  ICMJE August 1, 2018
Actual Primary Completion Date March 18, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2021)
  • Change in Body Weight (%) [ Time Frame: Baseline (week 0) to week 68 ]
    Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
  • Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5% [ Time Frame: After 68 weeks ]
    Number of participants who achieved greater than or equal to (≥) 5% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 5% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 5% weight loss. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption.
Original Primary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
  • Change in body weight [ Time Frame: Week 0, week 68 ]
    Measured in %
  • Subjects who achieve (yes/no): body weight reduction more than or equal to 5% [ Time Frame: Week 0, week 68 ]
    Number of subjects who achieve body weight reduction more than or equal to 5% from baseline (week 0) after 68 weeks.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2021)
  • Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10% [ Time Frame: After 68 weeks ]
    Number of participants who achieved greater than or equal to (≥) 10% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 10% weight loss whereas 'No' infers number of participants who have not achieved ≥ 10% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
  • Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15% [ Time Frame: After 68 weeks ]
    Number of participants who achieved greater than or equal to (≥) 15% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 15% weight loss whereas 'No' infers number of participants who have not achieved ≥ 15% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
  • Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20% [ Time Frame: After 68 weeks ]
    Number of participants who achieved greater than or equal to (≥) 20% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 20% weight loss whereas 'No' infers number of participants who have not achieved ≥ 20% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
  • Change in Waist Circumference [ Time Frame: Baseline (week 0) to week 68 ]
    Change in waist circumference from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
  • Change in Systolic Blood Pressure [ Time Frame: Baseline (week 0) to week 68 ]
    Change in systolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
  • Change in Short Form-36 (SF-36) - Physical Functioning Score [ Time Frame: Baseline (week 0) to week 68 ]
    SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 0 in the domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
  • Change in Body Weight (Kg) [ Time Frame: Baseline (week 0) to week 68 ]
    Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
  • Change in Body Mass Index [ Time Frame: Baseline (week 0) to week 68 ]
    Change in body mass index from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
  • Change in HbA1c (%) [ Time Frame: Baseline (week 0) to week 68 ]
    Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
  • Change in HbA1c (mmol/Mol) [ Time Frame: Baseline (week 0) to week 68 ]
    Change in HbA1c from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
  • Change in Fasting Plasma Glucose [ Time Frame: Baseline (week 0) to week 68 ]
    Change in fasting plasma glucose from week 0 to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
  • Change in Fasting Serum Insulin [ Time Frame: Baseline (week 0) to week 68 ]
    Change in fasting serum insulin from week 0 to week 68 [measured as milli-international units per milliliter (mIU/mL)] is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
  • Change in Diastolic Blood Pressure [ Time Frame: Baseline (week 0) to week 68 ]
    Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
  • Change in Total Cholesterol [ Time Frame: Baseline (week 0) to week 68 ]
    Change in fasting total cholesterol from baseline (week 0) to week 68 (measured as mg/dL) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
  • Change in High-density Lipoproteins (HDL) [ Time Frame: Baseline (week 0) to week 68 ]
    Change in fasting HDL from baseline (week 0) to week 68 (measured as mg/dL) is presented as ratio to baseline.The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
  • Change in Low-density Lipoproteins (LDL) [ Time Frame: Baseline (week 0) to week 68 ]
    Change in fasting LDL from baseline (week 0) to week 68 (measured as mg/dL) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
  • Change in Very Low Density Lipoprotein (VLDL) [ Time Frame: Baseline (week 0) to week 68 ]
    Change in fasting VLDL from baseline (week 0) to week 68 (measured as mg/dL) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
  • Change in Free Fatty Acids [ Time Frame: Baseline (week 0) to week 68 ]
    Change in fasting free fatty acids from baseline (week 0) to week 68 (measured as mg/dL) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
  • Change in Triglycerides [ Time Frame: Baseline (week 0) to week 68 ]
    Change in fasting triglycerides from baseline (week 0) to week 68 (measured as mg/dL) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
  • Change in High Sensitivity C-reactive Protein [ Time Frame: Baseline (week 0) to week 68 ]
    Change in high sensitivity C-reactive protein from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
  • Change in Plasminogen Activator Inhibitor-1 Activity [ Time Frame: Baseline (week 0) to week 68 ]
    Change in plasminogen activator inhibitor-1 activity from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
  • Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score [ Time Frame: After 68 weeks ]
    The observed number of participants experiencing a meaningful within participant improvement in SF-36 Physical function after 68 weeks was determined based on two thresholds. The threshold of 4.3 is the default generic responder threshold defined in SF-36 manual for a general population. The threshold of 3.7 is specific for overweight or obese population included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on Food and Drug Administration (FDA) recommendations. In the reported data, "Yes" infers number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on the in-trial observation period which is uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).
  • Change in Body Weight [ Time Frame: Baseline (week 0) to week 8 ]
    Change in body weight from baseline (week 0) to week 8 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).
  • Number of Treatment-emergent Adverse Events (AEs) [ Time Frame: Baseline (week 0) to week 75 ]
    An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event that had onset date (or increase in severity) on or after the first day of exposure to treatment. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).
  • Number of Serious Adverse Events (SAEs) [ Time Frame: Baseline (week 0) to week 75 ]
    A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred from week 0 to week 75 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).
  • Change in Pulse [ Time Frame: Baseline (week 0) to week 68 ]
    Change in pulse from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
  • Change in Amylase [ Time Frame: Baseline (week 0) to week 68 ]
    Change in amylase (measured as U/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
  • Change in Lipase [ Time Frame: Baseline (week 0) to week 68 ]
    Change in lipase (measured as U/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
  • Change in Calcitonin [ Time Frame: Baseline (week 0) to week 68 ]
    Change in calcitonin (measured as ng/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
Original Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
  • Subjects who achieve (yes/no): body weight reduction more than or equal to 10% [ Time Frame: Week 0, week 68 ]
    Number of subjects
  • Subjects who achieve (yes/no): body weight reduction more than or equal to 15% [ Time Frame: Week 0, week 68 ]
    Number of subjects
  • Change in waist circumference [ Time Frame: Week 0, week 68 ]
    Measured in cm
  • Change in systolic blood pressure [ Time Frame: Week 0, week 68 ]
    Measured in mmHg
  • Change in short form-36 (SF-36) - physical functioning score [ Time Frame: Week 0, week 68 ]
    SF-36 measures the subject's overall health related quality of life. It is a 36-item generic measure of health status that yields 2 summary scores for physical health and mental health, and 8 domain scores.
  • Change in Weight Related Sign and Symptom Measure (WRSSM) total score [ Time Frame: Week 0, week 68 ]
    The WRSSM measures the presence and bothersomeness of 10 weight-related symptoms. The tool assesses the multifaceted aspects of obesity on symptom experience.
  • Change in body weight [ Time Frame: Week 0, week 68 ]
    Measured in kg
  • Change in body mass index [ Time Frame: Week 0, week 68 ]
    Measured in kg/m^2
  • Change in hemoglobin A1c (HbA1c) [ Time Frame: Week 0, week 68 ]
    Measured in %
  • Change in HbA1c [ Time Frame: Week 0, week 68 ]
    Measured in mmol/mol
  • Change in fasting plasma glucose [ Time Frame: Week 0, week 68 ]
    Measured in mg/dL
  • Change in fasting serum insulin [ Time Frame: Week 0, week 68 ]
    Measured in micro IU/mL
  • Change in diastolic blood pressure [ Time Frame: Week 0, week 68 ]
    Measured in mmHg
  • Change in total cholesterol [ Time Frame: Week 0, week 68 ]
    Measured in mg/mL
  • Change in high-density lipoprotein [ Time Frame: Week 0, week 68 ]
    Measured in mg/mL
  • Change in low-density lipoprotein [ Time Frame: Week 0, week 68 ]
    Measured in mg/mL
  • Change in very low-density lipoprotein [ Time Frame: Week 0, week 68 ]
    Measured in mg/mL
  • Change in free fatty acids [ Time Frame: Week 0, week 68 ]
    Measured in mg/mL
  • Change in triglycerides [ Time Frame: Week 0, week 68 ]
    Measured in mg/mL
  • Change in high sensitivity C-reactive protein [ Time Frame: Week 0, week 68 ]
    Measured in mg/L
  • Change in plasminogen activator inhibitor-1 activity [ Time Frame: Week 0, week 68 ]
    Measured in UA/mL
  • Change in SF-36: Role-Physical score [ Time Frame: Week 0, week 68 ]
    SF-36 measures the subject's overall health related quality of life. It is a 36-item generic measure of health status that yields 2 summary scores for physical health and mental health, and 8 domain scores. Range of score is 1-100.
  • Change in SF-36: Bodily Pain score [ Time Frame: Week 0, week 68 ]
    SF-36 measures the subject's overall health related quality of life. It is a 36-item generic measure of health status that yields 2 summary scores for physical health and mental health, and 8 domain scores. Range of score is 1-100.
  • Change in SF-36: General Health score [ Time Frame: Week 0, week 68 ]
    SF-36 measures the subject's overall health related quality of life. It is a 36-item generic measure of health status that yields 2 summary scores for physical health and mental health, and 8 domain scores. Range of score is 1-100.
  • Change in SF-36: Vitality score [ Time Frame: Week 0, week 68 ]
    SF-36 measures the subject's overall health related quality of life. It is a 36-item generic measure of health status that yields 2 summary scores for physical health and mental health, and 8 domain scores. Range of score is 1-100.
  • Change in SF-36: Social Functioning score [ Time Frame: Week 0, week 68 ]
    SF-36 measures the subject's overall health related quality of life. It is a 36-item generic measure of health status that yields 2 summary scores for physical health and mental health, and 8 domain scores. Range of score is 1-100.
  • Change in SF-36: Role-Emotional score [ Time Frame: Week 0, week 68 ]
    SF-36 measures the subject's overall health related quality of life. It is a 36-item generic measure of health status that yields 2 summary scores for physical health and mental health, and 8 domain scores. Range of score is 1-100.
  • Change in SF-36: Mental Health score [ Time Frame: Week 0, week 68 ]
    SF-36 measures the subject's overall health related quality of life. It is a 36-item generic measure of health status that yields 2 summary scores for physical health and mental health, and 8 domain scores. Range of score is 1-100.
  • Change in SF-36: Physical component summary [ Time Frame: Week 0, week 68 ]
    SF-36 measures the subject's overall health related quality of life. It is a 36-item generic measure of health status that yields 2 summary scores for physical health and mental health, and 8 domain scores. Range of score is 1-100.
  • Change in SF-36: Mental component summary [ Time Frame: Week 0, week 68 ]
    SF-36 measures the subject's overall health related quality of life. It is a 36-item generic measure of health status that yields 2 summary scores for physical health and mental health, and 8 domain scores. Range of score is 1-100.
  • Subjects who achieve (yes/no): Responder definition value for SF-36 physical functioning score [ Time Frame: Week 68 ]
    Number of subjects
  • Subjects who achieve (yes/no): Responder definition value for WRSSM total score [ Time Frame: Week 68 ]
    Number of subjects
  • Change in body weight [ Time Frame: Week 0, week 8 ]
    Measured in %
  • Number of treatment-emergent adverse events (TEAEs) [ Time Frame: From week 0 to week 75 ]
    Number of events
  • Number of serious adverse events (SAEs) [ Time Frame: From week 0 to week 75 ]
    Number of events
  • Change in pulse [ Time Frame: Week 0, week 68 ]
    Measured in beats per minute
  • Change in amylase [ Time Frame: Week 0, week 68 ]
    Measured in U/L
  • Change in lipase [ Time Frame: Week 0, week 68 ]
    Measured in U/L
  • Change in calcitonin [ Time Frame: Week 0, week 68 ]
    Measured in ng/L
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program
Official Title  ICMJE Effect and Safety of Semaglutide 2.4 mg Once-weekly as Adjunct to Intensive Behavioural Therapy in Subjects With Overweight or Obesity
Brief Summary This study will look at the change in participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. Together with the medicine, the participant will also be part of an intensive lifestyle program where the participant will have talks with study staff about healthy food choices, what the participant can do to lose weight and be more physically active. The participant will either get semaglutide or "dummy" medicine - which treatment the participant gets is decided by chance. The participant will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. For the first 2 months the participant will be on a low calorie diet. The diet is made up of bars, shakes and 1 low calorie pre-prepared meal for each day. The study will last for about 1.5 years. The participant will have 32 clinic visits with the study doctor.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Overweight
  • Obesity
Intervention  ICMJE
  • Drug: Semaglutide
    Subcutaneous (s.c., under the skin) injections of semaglutide once weekly at escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks.
  • Drug: Placebo (semaglutide)
    S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks.
Study Arms  ICMJE
  • Experimental: Semaglutide
    Participants will receive semaglutide 2.4 mg during 68-week treatment period in addition to intensive behavioural therapy.
    Intervention: Drug: Semaglutide
  • Placebo Comparator: Semaglutide placebo
    Participants will receive semaglutide placebo during 68-week treatment period in addition to intensive behavioural therapy.
    Intervention: Drug: Placebo (semaglutide)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2019)
611
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2018)
600
Actual Study Completion Date  ICMJE April 28, 2020
Actual Primary Completion Date March 18, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female, age more than or equal to 18 years at the time of signing informed consent
  • Body mass index more than or equal to 30 kg/m^2 or more than or equal to 27 kg/m^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
  • History of at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion Criteria:

  • Hemoglobin A1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening
  • A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03611582
Other Study ID Numbers  ICMJE NN9536-4375
U1111-1200-8199 ( Other Identifier: World Health Organization (WHO) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP