Study · Randomized controlled trial · n = 803 · 2021

6 results

Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity: The STEP 4 Randomized Clinical Trial.

Rubino D, Abrahamsson N, Davies M, Hesse D, Greenway FL, Jensen C, Lingvay I, Mosenzon O, Rosenstock J, Rubio MA, Rudofsky G, Tadayon S, Wadden TA, Dicker D

JAMA1 Apr 2021Cited by 1,095 (Europe PMC)

PMID33755728PMCIDPMC7988425DOI10.1001/jama.2021.3224PepBankPUB-33755728

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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 after a 20-week run-in, continued semaglutide reduced body weight versus switching to placebo, which led to weight regain.
In plain wordsIn adults with overweight or obesity, people who kept taking semaglutide lost more weight than people switched to placebo, who regained weight.
Peptide
Semaglutide
Outcome
DecreaseBody weight change from week 20 to week 68
Study
n = 803
Comparator
Switch to placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
2.4 mg once weekly · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Body weight change
−7.9%
continued semaglutide
Body weight change
6.9%
switch to placebo
Difference
−14.8 percentage points
continued semaglutide vs placebo
Source sentences
Summary
With continued semaglutide, mean body weight change from week 20 to week 68 was -7.9% vs +6.9% with the switch to placebo (difference, -14.8 [95% CI, -16.0 to -13.5] percentage points; P < .001).
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, 68-week phase 3a withdrawal study conducted at 73 sites in 10 countries from June 2018 to March 2020 in adults with body mass index of at least 30 (or ≥27 with ≥1 weight-related comorbidity) and without diabetes.
Summary · context
After 20 weeks (16 weeks of dose escalation; 4 weeks of maintenance dose), 803 participants (89.0%) who reached the 2.4-mg/wk semaglutide maintenance dose were randomized (2:1) to 48 weeks of continued subcutaneous semaglutide (n = 535) or switched to placebo (n = 268), plus lifestyle intervention in both groups.
Report a problemFND-3375572801
02HumanRandomized controlled trialEfficacy outcome
In adults with overweight or obesity after a 20-week run-in, continued semaglutide reduced waist circumference versus switching to placebo.
In plain wordsIn adults with overweight or obesity, waist size fell more with continued semaglutide than with a switch to placebo.
Peptide
Semaglutide
Outcome
DecreaseWaist circumference change
Study
n = 803
Comparator
Switch to placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
2.4 mg once weekly · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Waist circumference difference
−9.7 cm
continued semaglutide vs placebo
Source sentences
Summary
Waist circumference (-9.7 cm [95% CI, -10.9 to -8.5 cm]), systolic blood pressure (-3.9 mm Hg [95% CI, -5.8 to -2.0 mm Hg]), and SF-36 physical functioning score (2.5 [95% CI, 1.6-3.3]) also improved with continued subcutaneous semaglutide vs placebo (all P < .001).
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, 68-week phase 3a withdrawal study conducted at 73 sites in 10 countries from June 2018 to March 2020 in adults with body mass index of at least 30 (or ≥27 with ≥1 weight-related comorbidity) and without diabetes.
Summary · context
After 20 weeks (16 weeks of dose escalation; 4 weeks of maintenance dose), 803 participants (89.0%) who reached the 2.4-mg/wk semaglutide maintenance dose were randomized (2:1) to 48 weeks of continued subcutaneous semaglutide (n = 535) or switched to placebo (n = 268), plus lifestyle intervention in both groups.
Report a problemFND-3375572802
03HumanRandomized controlled trialEfficacy outcome
In adults with overweight or obesity after a 20-week run-in, continued semaglutide lowered systolic blood pressure versus switching to placebo.
In plain wordsIn adults with overweight or obesity, systolic blood pressure fell more with continued semaglutide than with a switch to placebo.
Peptide
Semaglutide
Outcome
DecreaseSystolic blood pressure change
Study
n = 803
Comparator
Switch to placebo
Analysis
Secondary
Outcome group
Blood pressure · Cardiovascular
Studied dose
2.4 mg once weekly · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Systolic blood pressure difference
−3.9 mm Hg
continued semaglutide vs placebo
Source sentences
Summary
Waist circumference (-9.7 cm [95% CI, -10.9 to -8.5 cm]), systolic blood pressure (-3.9 mm Hg [95% CI, -5.8 to -2.0 mm Hg]), and SF-36 physical functioning score (2.5 [95% CI, 1.6-3.3]) also improved with continued subcutaneous semaglutide vs placebo (all P < .001).
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, 68-week phase 3a withdrawal study conducted at 73 sites in 10 countries from June 2018 to March 2020 in adults with body mass index of at least 30 (or ≥27 with ≥1 weight-related comorbidity) and without diabetes.
Summary · context
After 20 weeks (16 weeks of dose escalation; 4 weeks of maintenance dose), 803 participants (89.0%) who reached the 2.4-mg/wk semaglutide maintenance dose were randomized (2:1) to 48 weeks of continued subcutaneous semaglutide (n = 535) or switched to placebo (n = 268), plus lifestyle intervention in both groups.
Report a problemFND-3375572803
04HumanRandomized controlled trialEfficacy outcome
In adults with overweight or obesity after a 20-week run-in, continued semaglutide improved the SF-36 physical functioning score versus switching to placebo.
In plain wordsIn adults with overweight or obesity, self-reported physical functioning improved more with continued semaglutide than with a switch to placebo.
Peptide
Semaglutide
Outcome
IncreaseSF-36 physical functioning score
Study
n = 803
Comparator
Switch to placebo
Analysis
Secondary
Outcome group
Exercise and physical function · Whole body
Studied dose
2.4 mg once weekly · subcutaneous · 48 weeksAs given in this study (human).
Measurements
SF-36 physical functioning difference
2.5 points
continued semaglutide vs placebo
Source sentences
Summary
Waist circumference (-9.7 cm [95% CI, -10.9 to -8.5 cm]), systolic blood pressure (-3.9 mm Hg [95% CI, -5.8 to -2.0 mm Hg]), and SF-36 physical functioning score (2.5 [95% CI, 1.6-3.3]) also improved with continued subcutaneous semaglutide vs placebo (all P < .001).
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, 68-week phase 3a withdrawal study conducted at 73 sites in 10 countries from June 2018 to March 2020 in adults with body mass index of at least 30 (or ≥27 with ≥1 weight-related comorbidity) and without diabetes.
Summary · context
After 20 weeks (16 weeks of dose escalation; 4 weeks of maintenance dose), 803 participants (89.0%) who reached the 2.4-mg/wk semaglutide maintenance dose were randomized (2:1) to 48 weeks of continued subcutaneous semaglutide (n = 535) or switched to placebo (n = 268), plus lifestyle intervention in both groups.
Report a problemFND-3375572804
05HumanRandomized controlled trialSafety outcome
In adults with overweight or obesity after a 20-week run-in, gastrointestinal events were reported by more participants on continued semaglutide than on placebo.
In plain wordsIn adults with overweight or obesity, stomach and gut side effects were more common with continued semaglutide than with placebo.
Peptide
Semaglutide
Outcome
IncreaseGastrointestinal events
Study
n = 803
Comparator
Switch to placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
2.4 mg once weekly · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Participants with GI events
49.1%
continued semaglutide
Participants with GI events
26.1%
placebo
Source sentences
Summary
Gastrointestinal events were reported in 49.1% of participants who continued subcutaneous semaglutide vs 26.1% with placebo
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, 68-week phase 3a withdrawal study conducted at 73 sites in 10 countries from June 2018 to March 2020 in adults with body mass index of at least 30 (or ≥27 with ≥1 weight-related comorbidity) and without diabetes.
Summary · context
After 20 weeks (16 weeks of dose escalation; 4 weeks of maintenance dose), 803 participants (89.0%) who reached the 2.4-mg/wk semaglutide maintenance dose were randomized (2:1) to 48 weeks of continued subcutaneous semaglutide (n = 535) or switched to placebo (n = 268), plus lifestyle intervention in both groups.
Report a problemFND-3375572805
06HumanRandomized controlled trialSafety outcome
In adults with overweight or obesity after a 20-week run-in, similar proportions discontinued treatment because of adverse events with continued semaglutide and with placebo.
In plain wordsIn adults with overweight or obesity, about the same share of people stopped treatment because of side effects with continued semaglutide as with placebo.
Peptide
Semaglutide
Outcome
No significant changeDiscontinuation due to adverse events
Study
n = 803
Comparator
Switch to placebo
Outcome group
Adverse events · Whole body
Studied dose
2.4 mg once weekly · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Discontinuation due to adverse events
2.4%
continued semaglutide
Discontinuation due to adverse events
2.2%
placebo
Source sentences
Summary
similar proportions discontinued treatment because of adverse events with continued semaglutide (2.4%) and placebo (2.2%).
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, 68-week phase 3a withdrawal study conducted at 73 sites in 10 countries from June 2018 to March 2020 in adults with body mass index of at least 30 (or ≥27 with ≥1 weight-related comorbidity) and without diabetes.
Summary · context
After 20 weeks (16 weeks of dose escalation; 4 weeks of maintenance dose), 803 participants (89.0%) who reached the 2.4-mg/wk semaglutide maintenance dose were randomized (2:1) to 48 weeks of continued subcutaneous semaglutide (n = 535) or switched to placebo (n = 268), plus lifestyle intervention in both groups.
Report a problemFND-3375572806

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

Registered trials4

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

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

Not yet recruitingPhase 4NCT07462663

SHAPE-ENDO: Pilot Randomized Trial of Multimodal Pre-Surgical Optimization Versus Standard Surgery in Patients With Obesity and Early-Stage Endometrial Cancer

Hospital Universitari de Bellvitgen = 80est. Jan 2027 to est. Jan 2035

Endometrial Cancer · Endometrial Cancer Stage I · Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage I · Atypical Endometrial Hyperplasia · Endometrial Intraepithelial Neoplasia · Obesity & Overweight · BMI>40 · Obesity · Obesity Grade III

Trial page ClinicalTrials.govUpdated 10 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 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 postedNCT03548987

Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

Novo Nordisk A/Sn = 9024 Jun 2018 to 20 Mar 2020

Metabolism and Nutrition Disorder · Obesity

Trial page ClinicalTrials.govUpdated 19 Jan 2022

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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