Study · Randomized controlled trial · n = 611 · 2021

6 results

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.

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

JAMA1 Apr 2021Cited by 858 (Europe PMC)

PMID33625476PMCIDPMC7905697DOI10.1001/jama.2021.1831PepBankPUB-33625476

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with overweight or obesity receiving intensive behavioral therapy, semaglutide 2.4 mg reduced body weight more than placebo at week 68.
In plain wordsIn adults with overweight or obesity, semaglutide with intensive behavioral therapy led to more weight loss than placebo with the same therapy.
Peptide
Semaglutide
Outcome
DecreasePercentage change in body weight at week 68
Study
n = 611
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
2.4 mg once weekly · subcutaneous · 68 weeksAs given in this study (human).
Measurements
Body weight change
−16%
semaglutide
Body weight change
−5.7%
placebo
Difference
−10.3 percentage points
semaglutide vs placebo
Source sentences
Summary
At week 68, the estimated mean body weight change from baseline was -16.0% for semaglutide vs -5.7% for placebo (difference, -10.3 percentage points [95% CI, -12.0 to -8.6]; P < .001).
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, parallel-group, 68-week, phase 3a study (STEP 3) conducted at 41 sites in the US from August 2018 to April 2020 in adults without diabetes (N = 611) and with either overweight (body mass index ≥27) plus at least 1 comorbidity or obesity (body mass index ≥30).
Summary · context
Participants were randomized (2:1) to semaglutide, 2.4 mg (n = 407) or placebo (n = 204), both combined with a low-calorie diet for the first 8 weeks and intensive behavioral therapy (ie, 30 counseling visits) during 68 weeks.
Report a problemFND-3362547601
02HumanRandomized controlled trialEfficacy outcome
In adults with overweight or obesity receiving intensive behavioral therapy, more participants on semaglutide than on placebo lost at least 5% of baseline body weight.
In plain wordsIn adults with overweight or obesity, more people on semaglutide than on placebo lost at least 5% of their body weight.
Peptide
Semaglutide
Outcome
IncreaseWeight loss of at least 5% at week 68
Study
n = 611
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
2.4 mg once weekly · subcutaneous · 68 weeksAs given in this study (human).
Measurements
Proportion with weight loss of at least 5%
86.6%
semaglutide
Proportion with weight loss of at least 5%
47.6%
placebo
Source sentences
Summary
More participants treated with semaglutide vs placebo lost at least 5% of baseline body weight (86.6% vs 47.6%, respectively; P < .001).
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, parallel-group, 68-week, phase 3a study (STEP 3) conducted at 41 sites in the US from August 2018 to April 2020 in adults without diabetes (N = 611) and with either overweight (body mass index ≥27) plus at least 1 comorbidity or obesity (body mass index ≥30).
Summary · context
Participants were randomized (2:1) to semaglutide, 2.4 mg (n = 407) or placebo (n = 204), both combined with a low-calorie diet for the first 8 weeks and intensive behavioral therapy (ie, 30 counseling visits) during 68 weeks.
Report a problemFND-3362547602
03HumanRandomized controlled trialEfficacy outcome
In adults with overweight or obesity receiving intensive behavioral therapy, more participants on semaglutide than on placebo lost at least 10% of baseline body weight.
In plain wordsIn adults with overweight or obesity, more people on semaglutide than on placebo lost at least 10% of their body weight.
Peptide
Semaglutide
Outcome
IncreaseWeight loss of at least 10% at week 68
Study
n = 611
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
2.4 mg once weekly · subcutaneous · 68 weeksAs given in this study (human).
Measurements
Proportion with weight loss of at least 10%
75.3%
semaglutide
Proportion with weight loss of at least 10%
27%
placebo
Source sentences
Summary
A higher proportion of participants in the semaglutide vs placebo group achieved weight losses of at least 10% or 15% (75.3% vs 27.0% and 55.8% vs 13.2%, respectively; P < .001).
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, parallel-group, 68-week, phase 3a study (STEP 3) conducted at 41 sites in the US from August 2018 to April 2020 in adults without diabetes (N = 611) and with either overweight (body mass index ≥27) plus at least 1 comorbidity or obesity (body mass index ≥30).
Summary · context
Participants were randomized (2:1) to semaglutide, 2.4 mg (n = 407) or placebo (n = 204), both combined with a low-calorie diet for the first 8 weeks and intensive behavioral therapy (ie, 30 counseling visits) during 68 weeks.
Report a problemFND-3362547603
04HumanRandomized controlled trialEfficacy outcome
In adults with overweight or obesity receiving intensive behavioral therapy, more participants on semaglutide than on placebo lost at least 15% of baseline body weight.
In plain wordsIn adults with overweight or obesity, more people on semaglutide than on placebo lost at least 15% of their body weight.
Peptide
Semaglutide
Outcome
IncreaseWeight loss of at least 15% at week 68
Study
n = 611
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
2.4 mg once weekly · subcutaneous · 68 weeksAs given in this study (human).
Measurements
Proportion with weight loss of at least 15%
55.8%
semaglutide
Proportion with weight loss of at least 15%
13.2%
placebo
Source sentences
Summary
A higher proportion of participants in the semaglutide vs placebo group achieved weight losses of at least 10% or 15% (75.3% vs 27.0% and 55.8% vs 13.2%, respectively; P < .001).
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, parallel-group, 68-week, phase 3a study (STEP 3) conducted at 41 sites in the US from August 2018 to April 2020 in adults without diabetes (N = 611) and with either overweight (body mass index ≥27) plus at least 1 comorbidity or obesity (body mass index ≥30).
Summary · context
Participants were randomized (2:1) to semaglutide, 2.4 mg (n = 407) or placebo (n = 204), both combined with a low-calorie diet for the first 8 weeks and intensive behavioral therapy (ie, 30 counseling visits) during 68 weeks.
Report a problemFND-3362547604
05HumanRandomized controlled trialSafety outcome
In adults with overweight or obesity receiving intensive behavioral therapy, gastrointestinal adverse events were more frequent with semaglutide than with placebo.
In plain wordsIn adults with overweight or obesity, stomach and gut side effects were more common with semaglutide than with placebo.
Peptide
Semaglutide
Outcome
IncreaseGastrointestinal adverse events
Study
n: not reported in source
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
2.4 mg once weekly · subcutaneous · 68 weeksAs given in this study (human).
Measurements
Participants with GI adverse events
82.8%
semaglutide
Participants with GI adverse events
63.2%
placebo
Source sentences
Summary
Gastrointestinal adverse events were more frequent with semaglutide (82.8%) vs placebo (63.2%).
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, parallel-group, 68-week, phase 3a study (STEP 3) conducted at 41 sites in the US from August 2018 to April 2020 in adults without diabetes (N = 611) and with either overweight (body mass index ≥27) plus at least 1 comorbidity or obesity (body mass index ≥30).
Summary · context
Participants were randomized (2:1) to semaglutide, 2.4 mg (n = 407) or placebo (n = 204), both combined with a low-calorie diet for the first 8 weeks and intensive behavioral therapy (ie, 30 counseling visits) during 68 weeks.
Report a problemFND-3362547605
06HumanRandomized controlled trialSafety outcome
In adults with overweight or obesity receiving intensive behavioral therapy, more participants on semaglutide than on placebo stopped treatment because of gastrointestinal adverse events.
In plain wordsIn adults with overweight or obesity, more people on semaglutide than on placebo stopped treatment because of stomach and gut side effects.
Peptide
Semaglutide
Outcome
IncreaseDiscontinuation due to gastrointestinal adverse events
Study
n: not reported in source
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
2.4 mg once weekly · subcutaneous · 68 weeksAs given in this study (human).
Measurements
Discontinuation due to GI events
3.4%
semaglutide
Discontinuation due to GI events
0%
placebo
Source sentences
Summary
Treatment was discontinued owing to these events in 3.4% of semaglutide participants vs 0% of placebo participants.
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, parallel-group, 68-week, phase 3a study (STEP 3) conducted at 41 sites in the US from August 2018 to April 2020 in adults without diabetes (N = 611) and with either overweight (body mass index ≥27) plus at least 1 comorbidity or obesity (body mass index ≥30).
Summary · context
Participants were randomized (2:1) to semaglutide, 2.4 mg (n = 407) or placebo (n = 204), both combined with a low-calorie diet for the first 8 weeks and intensive behavioral therapy (ie, 30 counseling visits) during 68 weeks.
Report a problemFND-3362547606

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials5

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

5 trials · 1 ongoing · 1 not yet recruiting · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

Not yet recruitingPhase not statedNCT07668765

GLP-1 Receptor Agonists and Early Proctologic Effects in Morbid Obesity

Gazi Universityn = 100est. Aug 2026 to est. May 2027

Morbid Obesity · Anorectal Diseases · Drug-Related Side Effects and Adverse Reactions · Constipation · Diarrhea

Trial page ClinicalTrials.govUpdated 25 Jun 2026

RecruitingPhase 4NCT07513168

Low-Dose Semaglutide for Weight Loss in Obese Non-Diabetic Pakistani Adults

Asian Institute Of Medical Sciencesn = 601 Aug 2025 to est. 1 Dec 2026

Obesity · Weight Reduction · Cardiometabolic Risk Factors

Trial page ClinicalTrials.govUpdated 6 Apr 2026

Status unknownPhase 4NCT06438146

LIROH - Liraglutide for Obesity in HIV

Brigham and Women's Hospitaln = 402 May 2024 to est. May 2025

Obesity · HIV Infections

Trial page ClinicalTrials.govUpdated 31 May 2024

Status unknownPhase 4NCT06287307

Semaglutide 2.4mg for Low Responders After Bariatric Surgery

Zuyderland Medisch Centrumn = 152est. May 2024 to est. Sept 2026

Obesity · Obesity, Morbid · Weight Gain

Trial page ClinicalTrials.govUpdated 1 Mar 2024

CompletedPhase 3Results postedNCT03611582

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

Novo Nordisk A/Sn = 6111 Aug 2018 to 28 Apr 2020

Overweight · Obesity

Trial page ClinicalTrials.govUpdated 11 Nov 2021

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
9 Oct 2026, 18:17 UTC
Study results updated
Version 1
9 Oct 2026, 03:06 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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