Phase 3
Completed N=902
Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
Metabolism and Nutrition Disorder · Obesity
Source: ClinicalTrials.gov NCT03548987 ↗
Enrolled (actual)
902
Serious AEs
4.5%
Results posted
Mar 2021
Primary outcomePrimary: Change From Randomisation to Week 68 in Body Weight (%) — -8.3; 6.5; -8.8; 6.1 Percentage point — p=<0.0001
◆ Published Evidence
Highly cited
1,214citations · ~243 / year
Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity: The STEP 4 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. In addition to taking the medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what a participant can do to lose weight.
The participant will get semaglutide for the first 20 weeks. Then the participant will get either semaglutide or "dummy" medicine - which treatment the participant gets after the 20 weeks is decided by chance. The participants 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. The study will last for about 1.5 years.
Linked Publications (5)
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Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity: The STEP 4 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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Semaglutide improves cardiometabolic risk factors in adults with overweight or obesity: STEP 1 and 4 exploratory analyses.
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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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Effect of semaglutide 2.4 mg once weekly on 10-year type 2 diabetes risk in adults with overweight or obesity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Randomisation to Week 68 in Body Weight (%) |
-8.3; 6.5; -8.8; 6.1 | <0.0001 sig |
| SECONDARY Change in Waist Circumference |
-6.9; 3.2 | — |
| SECONDARY Change in Systolic Blood Pressure |
0; 5 | — |
| SECONDARY Change in Diastolic Blood Pressure |
0; 1 | — |
| SECONDARY Change in Physical Functioning Score (Short Form 36 [SF-36]) |
1.0; -1.2; 0.3; -0.9; 0.5; -1.5 | — |
| SECONDARY Change in Body Weight [Kilogram (Kg)] |
-7.5; 5.7 | — |
| SECONDARY Change in Body Mass Index (BMI) |
-2.7; 2.0 | — |
| SECONDARY Change in Haemoglobin A1c (HbA1c) [%] |
-0.2; 0.1 | — |
| SECONDARY Change in HbA1c [Millimoles Per Mole (mmol/Mol)] |
-1.7; 1.2 | — |
| SECONDARY Change in Fasting Plasma Glucose [Milligrams Per Deciliter (mg/dL)] |
-1.1; 7.6 | — |
| SECONDARY Change in Fasting Plasma Glucose [Millimoles Per Litre (mmol/L)] |
-0.1; 0.4 | — |
| SECONDARY Change in Fasting Serum Insulin |
0.81; 1.03 | — |
| SECONDARY Change in Total Cholesterol |
1.05; 1.11 | — |
| SECONDARY Change in High-density Lipoproteins (HDL) |
1.18; 1.18 | — |
| SECONDARY Change in Low-density Lipoproteins (LDL) |
1.01; 1.07 | — |
| SECONDARY Change in Very Low-density Lipoproteins (VLDL) |
0.94; 1.12 | — |
| SECONDARY Change in Free Fatty Acids |
0.78; 0.89 | — |
| SECONDARY Change in Triglycerides |
0.94; 1.12 | — |
| SECONDARY Subjects Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score |
58; 11; 457; 234 | — |
| SECONDARY Subjects Who Gain Weight (Yes/no) |
79; 206; 441; 44 | — |
| SECONDARY Change in Body Weight |
-17.7; -5.4 | — |
| SECONDARY Subjects Who Achieve (Yes/no): Body Weight Reduction < 0% |
22; 51; 498; 199 | — |
| SECONDARY Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 5% |
461; 119; 59; 131 | — |
| SECONDARY Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 10% |
411; 51; 109; 199 | — |
| SECONDARY Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 15% |
331; 23; 189; 227 | — |
| SECONDARY Number of Treatment-emergent Adverse Events (AEs) |
3775 | — |
| SECONDARY Number of Treatment-emergent AEs |
1885; 779 | — |
| SECONDARY Number of Serious Adverse Events (SAEs) |
51; 19 | — |
| SECONDARY Number of Serious Adverse Events (SAEs) |
51; 19 | — |
| SECONDARY Change in Pulse |
-2; -5 | — |
| SECONDARY Change in Pulse |
-2; -5 | — |
| SECONDARY Change in Amylase |
1.06; 1.00 | — |
| SECONDARY Change in Amylase |
1.06; 1.00 | — |
| SECONDARY Change in Lipase |
0.94; 0.68 | — |
| SECONDARY Change in Lipase |
0.94; 0.68 | — |
| SECONDARY Change in Calcitonin |
1.00; 0.95 | — |
| SECONDARY Change in Calcitonin |
1.00; 0.95 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female, age greater than or equal to 18 years at the time of signing informed consent
- Body mass index greater than or equal to 30 kg/sqm or greater than or equal to 27 kg/sqm 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
- Haemoglobin A1c greater than or equal to 48 mmol/mol (6.5%) as measured by 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 (NCT03548987) 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.