Once-weekly semaglutide 2·4 mg in an Asian population with obesity, defined as BMI ≥25 kg/m², in South Korea and Thailand (STEP 11): a randomised, double-blind, placebo-controlled, phase 3 trial.

Lim S, Buranapin S, Bao X, Quiroga M, Park KH, Kang JH, Rinnov AR, Suwanagool A

The lancet. Diabetes & endocrinology15 Aug 2025Cited by 14 (Europe PMC)

PMID40825340DOI10.1016/s2213-8587(25)00164-0PepBankPUB-40825340

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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 study9

9 results from studies that gave the peptide. 9 results from people.

01HumanRandomized controlled trialEfficacy outcome
In Asian adults with obesity, semaglutide 2·4 mg reduced bodyweight by 16·0% versus 3·1% with placebo at week 44 (p<0·0001).
In plain wordsIn Asian adults with obesity, semaglutide 2·4 mg led to much more weight loss than placebo over 44 weeks.
Peptide
Semaglutide
Outcome
DecreasePercentage bodyweight change at week 44
Study
n = 150
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
2·4 mg once weekly · subcutaneous · 44 weeksAs given in this study (human).
Measurements
Mean bodyweight change
−16%
semaglutide 2·4 mg
Mean bodyweight change
−3.1%
placebo
Source sentences
Summary
At week 44, mean change in bodyweight was -16·0% (SE 0·7) in the semaglutide 2·4 mg group versus -3·1% (0·9) in the placebo group (p<0·0001)
2 context sentences(design, population, supporting numbers)
Summary · context
STEP 11 was a 44-week, randomised, double-blind, placebo-controlled, phase 3 trial conducted at 12 clinical sites in South Korea and Thailand.
Summary · context
Adults (aged ≥18 years in Thailand and ≥19 years in South Korea) with obesity (BMI ≥25 kg/m²) of Asian descent, without diabetes, were randomly assigned 2:1 with a computer-generated sequence and block randomisation to once-weekly subcutaneous semaglutide 2·4 mg or placebo, with a reduced…
Report a problemFND-4082534001
02HumanRandomized controlled trialEfficacy outcome
In Asian adults with obesity, more participants reached a bodyweight reduction of at least 5% with semaglutide 2·4 mg than with placebo (96% vs 25%; p<0·0001).
In plain wordsIn Asian adults with obesity, far more people on semaglutide 2·4 mg lost at least 5% of their weight than on placebo.
Peptide
Semaglutide
Outcome
IncreaseBodyweight reduction of 5% or more
Study
n = 150
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
2·4 mg once weekly · subcutaneous · 44 weeksAs given in this study (human).
Measurements
Proportion with >=5% bodyweight reduction
96%
semaglutide 2·4 mg
Proportion with >=5% bodyweight reduction
25%
placebo
Source sentences
Summary
a greater proportion of participants reached bodyweight reductions of ≥5% (96 [96%] vs 12 [25%]; p<0·0001)
2 context sentences(design, population, supporting numbers)
Summary · context
STEP 11 was a 44-week, randomised, double-blind, placebo-controlled, phase 3 trial conducted at 12 clinical sites in South Korea and Thailand.
Summary · context
Adults (aged ≥18 years in Thailand and ≥19 years in South Korea) with obesity (BMI ≥25 kg/m²) of Asian descent, without diabetes, were randomly assigned 2:1 with a computer-generated sequence and block randomisation to once-weekly subcutaneous semaglutide 2·4 mg or placebo, with a reduced…
Report a problemFND-4082534002
03HumanRandomized controlled trialEfficacy outcome
In Asian adults with obesity, more participants reached a bodyweight reduction of at least 10% with semaglutide 2·4 mg than with placebo (78% vs 10%; p<0·0001).
In plain wordsIn Asian adults with obesity, far more people on semaglutide 2·4 mg lost at least 10% of their weight than on placebo.
Peptide
Semaglutide
Outcome
IncreaseBodyweight reduction of 10% or more
Study
n = 150
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
2·4 mg once weekly · subcutaneous · 44 weeksAs given in this study (human).
Measurements
Proportion with >=10% bodyweight reduction
78%
semaglutide 2·4 mg
Proportion with >=10% bodyweight reduction
10%
placebo
Source sentences
Summary
≥10% (78 [78%] vs 5 [10%]; p<0·0001)
3 context sentences(design, population, supporting numbers)
Summary · context
Confirmatory secondary endpoints were the proportion of participants with ≥10% and ≥15% bodyweight reductions and change in waist circumference.
Summary · context
STEP 11 was a 44-week, randomised, double-blind, placebo-controlled, phase 3 trial conducted at 12 clinical sites in South Korea and Thailand.
Summary · context
Adults (aged ≥18 years in Thailand and ≥19 years in South Korea) with obesity (BMI ≥25 kg/m²) of Asian descent, without diabetes, were randomly assigned 2:1 with a computer-generated sequence and block randomisation to once-weekly subcutaneous semaglutide 2·4 mg or placebo, with a reduced…
Report a problemFND-4082534003
04HumanRandomized controlled trialEfficacy outcome
In Asian adults with obesity, more participants reached a bodyweight reduction of at least 15% with semaglutide 2·4 mg than with placebo (53·0% vs 4·2%; p<0·0001).
In plain wordsIn Asian adults with obesity, far more people on semaglutide 2·4 mg lost at least 15% of their weight than on placebo.
Peptide
Semaglutide
Outcome
IncreaseBodyweight reduction of 15% or more
Study
n = 150
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
2·4 mg once weekly · subcutaneous · 44 weeksAs given in this study (human).
Measurements
Proportion with >=15% bodyweight reduction
53%
semaglutide 2·4 mg
Proportion with >=15% bodyweight reduction
4.2%
placebo
Source sentences
Summary
≥15% (53 [53·0%] vs 2 [4·2%]; p<0·0001)
3 context sentences(design, population, supporting numbers)
Summary · context
Confirmatory secondary endpoints were the proportion of participants with ≥10% and ≥15% bodyweight reductions and change in waist circumference.
Summary · context
STEP 11 was a 44-week, randomised, double-blind, placebo-controlled, phase 3 trial conducted at 12 clinical sites in South Korea and Thailand.
Summary · context
Adults (aged ≥18 years in Thailand and ≥19 years in South Korea) with obesity (BMI ≥25 kg/m²) of Asian descent, without diabetes, were randomly assigned 2:1 with a computer-generated sequence and block randomisation to once-weekly subcutaneous semaglutide 2·4 mg or placebo, with a reduced…
Report a problemFND-4082534004
05HumanRandomized controlled trialEfficacy outcome
In Asian adults with obesity, waist circumference fell by 11·9 cm with semaglutide versus 3·0 cm with placebo (p<0·0001).
In plain wordsIn Asian adults with obesity, semaglutide reduced waist size more than placebo.
Peptide
Semaglutide
Outcome
DecreaseWaist circumference change
Study
n = 150
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
2·4 mg once weekly · subcutaneous · 44 weeksAs given in this study (human).
Measurements
Mean waist circumference change
−11.9 cm
semaglutide
Mean waist circumference change
−3 cm
placebo
Source sentences
Summary
Mean change in waist circumference was -11·9 cm (SE 0·7) with semaglutide versus -3·0 cm (1·0) with placebo (p<0·0001).
2 context sentences(design, population, supporting numbers)
Summary · context
STEP 11 was a 44-week, randomised, double-blind, placebo-controlled, phase 3 trial conducted at 12 clinical sites in South Korea and Thailand.
Summary · context
Adults (aged ≥18 years in Thailand and ≥19 years in South Korea) with obesity (BMI ≥25 kg/m²) of Asian descent, without diabetes, were randomly assigned 2:1 with a computer-generated sequence and block randomisation to once-weekly subcutaneous semaglutide 2·4 mg or placebo, with a reduced…
Report a problemFND-4082534005
06HumanRandomized controlled trialSafety outcome
Adverse events were reported by 89% of participants with semaglutide 2·4 mg and 78% with placebo; no test is reported.
In plain wordsAdverse events were reported by more people on semaglutide 2·4 mg than on placebo, though no test of the difference is given.
Peptide
Semaglutide
Outcome
IncreaseAny adverse events
Study
n = 150
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
2·4 mg once weekly · subcutaneous · 44 weeksAs given in this study (human).
Measurements
Participants with adverse events
89%
semaglutide 2·4 mg
Participants with adverse events
78%
placebo
Source sentences
Summary
Adverse events were reported by 90 (89%) of 101 participants in the semaglutide 2·4 mg group and 38 (78%) of 49 participants in the placebo group
3 context sentences(design, population, supporting numbers)
Summary · context
Safety was assessed via the assessment of adverse events in all participants who received at least one dose of semaglutide or placebo.
Summary · context
STEP 11 was a 44-week, randomised, double-blind, placebo-controlled, phase 3 trial conducted at 12 clinical sites in South Korea and Thailand.
Summary · context
Adults (aged ≥18 years in Thailand and ≥19 years in South Korea) with obesity (BMI ≥25 kg/m²) of Asian descent, without diabetes, were randomly assigned 2:1 with a computer-generated sequence and block randomisation to once-weekly subcutaneous semaglutide 2·4 mg or placebo, with a reduced…
Report a problemFND-4082534006
07HumanRandomized controlled trialSafety outcome
Serious adverse events were reported by 13% of participants with semaglutide 2·4 mg versus 8% with placebo; no test is reported.
In plain wordsSerious adverse events were reported by more people on semaglutide 2·4 mg than on placebo, though no test of the difference is given.
Peptide
Semaglutide
Outcome
IncreaseSerious adverse events
Study
n = 150
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
2·4 mg once weekly · subcutaneous · 44 weeksAs given in this study (human).
Measurements
Participants with serious adverse events
13%
semaglutide 2·4 mg
Participants with serious adverse events
8%
placebo
Source sentences
Summary
with 13 (13%) reporting serious adverse events in the semaglutide 2·4 mg group versus four (8%) in the placebo group.
3 context sentences(design, population, supporting numbers)
Summary · context
Safety was assessed via the assessment of adverse events in all participants who received at least one dose of semaglutide or placebo.
Summary · context
STEP 11 was a 44-week, randomised, double-blind, placebo-controlled, phase 3 trial conducted at 12 clinical sites in South Korea and Thailand.
Summary · context
Adults (aged ≥18 years in Thailand and ≥19 years in South Korea) with obesity (BMI ≥25 kg/m²) of Asian descent, without diabetes, were randomly assigned 2:1 with a computer-generated sequence and block randomisation to once-weekly subcutaneous semaglutide 2·4 mg or placebo, with a reduced…
Report a problemFND-4082534007
08HumanRandomized controlled trialSafety outcome
Gastrointestinal adverse events were the most common adverse events in the semaglutide group.
In plain wordsStomach and gut side effects were the most common side effects with semaglutide.
Peptide
Semaglutide
Outcome
Direction not reportedGastrointestinal adverse events
Study
n = 150
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
2·4 mg once weekly · subcutaneous · 44 weeksAs given in this study (human).
Source sentences
Summary
Gastrointestinal adverse events were the most common adverse events in participants in the semaglutide group.
3 context sentences(design, population, supporting numbers)
Summary · context
Safety was assessed via the assessment of adverse events in all participants who received at least one dose of semaglutide or placebo.
Summary · context
STEP 11 was a 44-week, randomised, double-blind, placebo-controlled, phase 3 trial conducted at 12 clinical sites in South Korea and Thailand.
Summary · context
Adults (aged ≥18 years in Thailand and ≥19 years in South Korea) with obesity (BMI ≥25 kg/m²) of Asian descent, without diabetes, were randomly assigned 2:1 with a computer-generated sequence and block randomisation to once-weekly subcutaneous semaglutide 2·4 mg or placebo, with a reduced…
Report a problemFND-4082534008
09HumanRandomized controlled trialSafety outcome
Six participants (6%) on semaglutide and two (4%) on placebo discontinued treatment before week 44; no test is reported.
In plain wordsA few more people on semaglutide than on placebo stopped treatment early, though no test of the difference is given.
Peptide
Semaglutide
Outcome
IncreaseTreatment discontinuation before week 44
Study
n = 150
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
2·4 mg once weekly · subcutaneous · 44 weeksAs given in this study (human).
Measurements
Discontinued before week 44
6%
semaglutide 2·4 mg
Discontinued before week 44
4%
placebo
Source sentences
Summary
Six (6%) in the semaglutide group and two (4%) in the placebo group discontinued treatment before week 44.
2 context sentences(design, population, supporting numbers)
Summary · context
STEP 11 was a 44-week, randomised, double-blind, placebo-controlled, phase 3 trial conducted at 12 clinical sites in South Korea and Thailand.
Summary · context
Adults (aged ≥18 years in Thailand and ≥19 years in South Korea) with obesity (BMI ≥25 kg/m²) of Asian descent, without diabetes, were randomly assigned 2:1 with a computer-generated sequence and block randomisation to once-weekly subcutaneous semaglutide 2·4 mg or placebo, with a reduced…
Report a problemFND-4082534009

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 postedNCT04998136

Research Study Investigating How Well Semaglutide Works in People From Thailand and South Korea Living With Obesity

Novo Nordisk A/Sn = 15015 Aug 2022 to 20 Nov 2023

Obesity

Trial page ClinicalTrials.govUpdated 30 Dec 2025

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.

Publication types

MeSH terms

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