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

• 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: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

Tracking Information

• First Submitted Date: July 17, 2018
• First Posted Date: August 2, 2018
• Results First Submitted Date: June 16, 2021
• Results First Posted Date: July 9, 2021
• Last Update Posted Date: November 11, 2021
• Actual Study Start Date: August 1, 2018
• Actual Primary Completion Date: March 18, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Overweight
• Obesity

Intervention

• 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

• 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 *

• Kushner RF, Calanna S, Davies M, Dicker D, Garvey WT, Goldman B, Lingvay I, Thomsen M, Wadden TA, Wharton S, Wilding JPH, Rubino D. Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5. Obesity (Silver Spring). 2020 Jun;28(6):1050-1061. doi: 10.1002/oby.22794.
• Wadden TA, Bailey TS, Billings LK, Davies M, Frias JP, Koroleva A, Lingvay I, O'Neil PM, Rubino DM, Skovgaard D, Wallenstein SOR, Garvey WT; STEP 3 Investigators. Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity: The STEP 3 Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1403-1413. doi: 10.1001/jama.2021.1831.
• Perreault L, Davies M, Frias JP, Laursen PN, Lingvay I, Machineni S, Varbo A, Wilding JPH, Wallenstein SOR, le Roux CW. Changes in Glucose Metabolism and Glycemic Status With Once-Weekly Subcutaneous Semaglutide 2.4 mg Among Participants With Prediabetes in the STEP Program. Diabetes Care. 2022 Oct 1;45(10):2396-2405. doi: 10.2337/dc21-1785.
• O'Neil PM, Birkenfeld AL, McGowan B, Mosenzon O, Pedersen SD, Wharton S, Carson CG, Jepsen CH, Kabisch M, Wilding JPH. Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial. Lancet. 2018 Aug 25;392(10148):637-649. doi: 10.1016/S0140-6736(18)31773-2. Epub 2018 Aug 16.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 9, 2019): 611
• Original Estimated Enrollment (submitted: August 1, 2018): 600
• Actual Study Completion Date: April 28, 2020
• Actual Primary Completion Date: March 18, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03611582
• Other Study ID Numbers: 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

• Plan to Share IPD: Yes
• Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
• URL: http://novonordisk-trials.com

• Current Responsible Party: Novo Nordisk A/S
• Original Responsible Party: Same as current
• Current Study Sponsor: Novo Nordisk A/S
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Reporting Anchor and Disclosure (1452); Novo Nordisk A/S

• PRS Account: Novo Nordisk A/S
• Verification Date: November 2021