Phase 3
Completed N=611
Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program
Source: ClinicalTrials.gov NCT03611582 ↗Enrolled (actual)
611
Serious AEs
7.0%
Results posted
Jul 2021
Primary outcomePrimary: Change in Body Weight (%) — -16.5; -5.8; -17.6; -6.1 Percentage — p=<.0001
◆ Published Evidence
Highly cited
989citations · ~198 / year
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.
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.
Linked Publications (5)
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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.
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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.
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Effects of Semaglutide on Albuminuria and Kidney Function in People With Overweight or Obesity With or Without Type 2 Diabetes: Exploratory Analysis From the STEP 1, 2, and 3 Trials.
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Changes in Glucose Metabolism and Glycemic Status With Once-Weekly Subcutaneous Semaglutide 2.4 mg Among Participants With Prediabetes in the STEP Program.
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Psychiatric Safety of Semaglutide for Weight Management in People Without Known Major Psychopathology: Post Hoc Analysis of the STEP 1, 2, 3, and 5 Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Body Weight (%) |
-16.5; -5.8; -17.6; -6.1 | <.0001 sig |
| PRIMARY Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5% |
323; 90; 50; 99; 300; 82 | <0.0001 sig |
| SECONDARY Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10% |
281; 51; 92; 138 | — |
| SECONDARY Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15% |
208; 25; 165; 164 | — |
| SECONDARY Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20% |
133; 7; 240; 182 | — |
| SECONDARY Change in Waist Circumference |
-15.2; -6.1 | — |
| SECONDARY Change in Systolic Blood Pressure |
-6; -2 | — |
| SECONDARY Change in Short Form-36 (SF-36) - Physical Functioning Score |
2.5; 1.7; 1.6; 1.5; 1.3; 0.6 | — |
| SECONDARY Change in Body Weight (Kg) |
-17.5; -6.2 | — |
| SECONDARY Change in Body Mass Index |
-6.2; -2.2 | — |
| SECONDARY Change in HbA1c (%) |
-0.5; -0.3 | — |
| SECONDARY Change in HbA1c (mmol/Mol) |
-5.8; -3.1 | — |
| SECONDARY Change in Fasting Plasma Glucose |
-7.3; -1.1 | — |
| SECONDARY Change in Fasting Serum Insulin |
0.68; 0.84 | — |
| SECONDARY Change in Diastolic Blood Pressure |
-3; -1 | — |
| SECONDARY Change in Total Cholesterol |
0.96; 1.01 | — |
| SECONDARY Change in High-density Lipoproteins (HDL) |
1.06; 1.05 | — |
| SECONDARY Change in Low-density Lipoproteins (LDL) |
0.96; 1.01 | — |
| SECONDARY Change in Very Low Density Lipoprotein (VLDL) |
0.77; 0.91 | — |
| SECONDARY Change in Free Fatty Acids |
0.86; 1.08 | — |
| SECONDARY Change in Triglycerides |
0.77; 0.91 | — |
| SECONDARY Change in High Sensitivity C-reactive Protein |
0.40; 0.76 | — |
| SECONDARY Change in Plasminogen Activator Inhibitor-1 Activity |
0.92; 1.26 | — |
| SECONDARY Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score |
86; 36; 278; 145; 133; 51 | — |
| SECONDARY Change in Body Weight |
-7.8; -6.0 | — |
| SECONDARY Number of Treatment-emergent Adverse Events (AEs) |
4035; 1325 | — |
| SECONDARY Number of Serious Adverse Events (SAEs) |
55; 7 | — |
| SECONDARY Change in Pulse |
3; 2 | — |
| SECONDARY Change in Amylase |
1.12; 1.07 | — |
| SECONDARY Change in Lipase |
1.31; 0.94 | — |
| SECONDARY Change in Calcitonin |
0.93; 0.94 | — |
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
Data sourced from ClinicalTrials.gov (NCT03611582) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.