Efficacy and safety of once-weekly semaglutide 2·4 mg versus placebo in people with obesity and prediabetes (STEP 10): a randomised, double-blind, placebo-controlled, multicentre phase 3 trial.

McGowan BM, Bruun JM, Capehorn M, Pedersen SD, Pietiläinen KH, Muniraju HAK, Quiroga M, Varbo A, Lau DCW

The lancet. Diabetes & endocrinology29 Jul 2024Cited by 136 (Europe PMC)

PMID39089293DOI10.1016/s2213-8587(24)00182-7PepBankPUB-39089293

Publisher page PubMedAsk about this study

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 study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with obesity and prediabetes, semaglutide 2.4 mg reduced bodyweight more than placebo at week 52.
In plain wordsIn adults with obesity and prediabetes, semaglutide 2.4 mg lowered body weight much more than placebo after 52 weeks.
Peptide
Semaglutide
Outcome
DecreasePercentage change in bodyweight at week 52
Study
n = 207
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
2.4 mg once weekly · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Bodyweight change
−13.9%
semaglutide 2.4 mg
Bodyweight change
−2.7%
placebo
Estimated treatment difference
−11.2%
semaglutide versus placebo
Source sentences
Summary
There was a significantly greater reduction in bodyweight with semaglutide 2·4 mg than with placebo at week 52 (-13·9% [SD 0·7] vs -2·7% [0·6]; estimated treatment difference -11·2% [95% CI -13·0 to -9·4]; p<0·0001).
1 context sentence(design, population, supporting numbers)
Summary · context
Participants were randomly assigned (2:1) to once-weekly subcutaneous semaglutide 2·4 mg or placebo with diet and physical activity counselling for 52 weeks, followed by a 28-week off-treatment period.
Report a problemFND-3908929301
02HumanRandomized controlled trialEfficacy outcome
In adults with obesity and prediabetes, a greater proportion reverted to normoglycaemia with semaglutide 2.4 mg than with placebo at week 52.
In plain wordsIn adults with obesity and prediabetes, more people returned to normal blood sugar with semaglutide 2.4 mg than with placebo.
Peptide
Semaglutide
Outcome
IncreaseReversion to normoglycaemia at week 52
Study
n = 191
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2.4 mg once weekly · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Reversion to normoglycaemia
81%
semaglutide 2.4 mg
Reversion to normoglycaemia
14%
placebo
Source sentences
Summary
Greater proportions of participants reverted to normoglycaemia at week 52 with semaglutide 2·4 mg than with placebo (103 [81%] of 127 vs nine [14%] of 64; odds ratio 19·8 [95% CI 8·7 to 45·2]; p<0·0001).
1 context sentence(design, population, supporting numbers)
Summary · context
Participants were randomly assigned (2:1) to once-weekly subcutaneous semaglutide 2·4 mg or placebo with diet and physical activity counselling for 52 weeks, followed by a 28-week off-treatment period.
Report a problemFND-3908929302
03HumanRandomized controlled trialSafety outcome
In adults with obesity and prediabetes, serious adverse events occurred in 9% of participants on semaglutide 2.4 mg and 9% on placebo.
In plain wordsIn adults with obesity and prediabetes, serious side effects occurred equally often with semaglutide 2.4 mg and with placebo.
Peptide
Semaglutide
Outcome
No significant changeSerious adverse events
Study
n = 207
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
2.4 mg once weekly · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Serious adverse events
12 participants
semaglutide 2.4 mg
Serious adverse events
6 participants
placebo
Source sentences
Summary
Serious adverse events occurred in 12 (9%) participants receiving semaglutide 2·4 mg versus six (9%) receiving placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
Participants were randomly assigned (2:1) to once-weekly subcutaneous semaglutide 2·4 mg or placebo with diet and physical activity counselling for 52 weeks, followed by a 28-week off-treatment period.
Report a problemFND-3908929303
04HumanRandomized controlled trialSafety outcome
In adults with obesity and prediabetes, adverse events led to treatment discontinuation in 6% on semaglutide 2.4 mg versus 1% on placebo.
In plain wordsIn adults with obesity and prediabetes, more people stopped treatment because of side effects with semaglutide 2.4 mg than with placebo.
Peptide
Semaglutide
Outcome
IncreaseAdverse events leading to discontinuation
Study
n = 207
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
2.4 mg once weekly · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Discontinuation due to adverse events
6%
semaglutide 2.4 mg
Discontinuation due to adverse events
1%
placebo
Source sentences
Summary
Adverse events leading to treatment discontinuation occurred in eight (6%) participants in the semaglutide 2·4 mg group versus one (1%) participant in the placebo group.
1 context sentence(design, population, supporting numbers)
Summary · context
Participants were randomly assigned (2:1) to once-weekly subcutaneous semaglutide 2·4 mg or placebo with diet and physical activity counselling for 52 weeks, followed by a 28-week off-treatment period.
Report a problemFND-3908929304
05HumanRandomized controlled trialSafety outcome
In adults with obesity and prediabetes, no new safety signals were reported with semaglutide 2.4 mg.
In plain wordsIn adults with obesity and prediabetes, no new safety concerns were reported with semaglutide 2.4 mg.
Peptide
Semaglutide
Outcome
No significant changeNew safety signals
Study
n = 207
Outcome group
Adverse events · Whole body
Studied dose
2.4 mg once weekly · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
No new safety signals were reported.
1 context sentence(design, population, supporting numbers)
Summary · context
Participants were randomly assigned (2:1) to once-weekly subcutaneous semaglutide 2·4 mg or placebo with diet and physical activity counselling for 52 weeks, followed by a 28-week off-treatment period.
Report a problemFND-3908929305

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

Registered trials1

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

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT05040971

Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes

Novo Nordisk A/Sn = 2076 Sept 2021 to 14 Jul 2023

Obesity

Trial page ClinicalTrials.govUpdated 29 Jan 2026

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
11 Oct 2026, 00:04 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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