Efficacy and safety of once weekly semaglutide 2·4 mg for weight management in a predominantly east Asian population with overweight or obesity (STEP 7): a double-blind, multicentre, randomised controlled trial
Primary result · Estimated mean percentage change in bodyweightResult — go to the resultEstimated treatment difference −8.5 percentage points 95% CI −10.2 to −6.8Authors' conclusion
The results of this study support the use of semaglutide 2.4 mg for weight management in people of east Asian ethnicity with overweight or obesity and with or without type 2 diabetes.
Study context
- Population
- Predominantly east Asian adults with overweight or obesity, with or without T2D, from 23 hospitals and trial centres in China, Hong Kong, Brazil and South Korearandomized 2:1
- Participants
- 375 adults
- Comparison
- Once-weekly SC semaglutide 2.4 mg vs placebo, plus diet and physical activity intervention, for 44 weeks
- Semaglutide 2.4 mgn = 249
- Placebon = 126reference
- Primary endpoint
- Co-primary: percentage change in mean bodyweight, and proportion of participants with ≥5% bodyweight reduction
- Follow-up
- Baseline to week 44
Methodological detailsphase 3a, double-blind, multicentre, stratified by T2D diagnosis, Randomisation in blocks of six via interactive web response system, Participants and investigators masked until after database lock
- Phase 3a
- Double-blind
- Multicentre
- Stratified by T2D diagnosis
- Randomisation in blocks of six via interactive web response system
- Participants and investigators masked until after database lock
Primary result
Estimated mean percentage change in bodyweight
Estimated treatment difference
−8.5 percentage points
95% CI −10.2 to −6.8
P < 0.0001
Change by group
Semaglutide 2.4 mg
−12.1
mean · SE 0.5 · %
Placebo
−3.6
mean · SE 0.7 · %
Semaglutide 2.4 mgvs Placebo
estimated treatment difference −8.5 percentage points (95% CI −10.2 to −6.8); P < 0.0001
As reported in the abstract
Further findings
| Outcome | Semaglutide 2.4 mg | Placebo | OR (95% CI) | P value | |
|---|---|---|---|---|---|
| Bodyweight loss ≥5% (co-primary endpoint) · week 44Co-primary endpoint | 85% | 31% | 13.1 (7.4–23.1) | P < 0.0001 | |
| 0.050.21520Odds ratio (log scale) |
Safety
Adverse events
Gastrointestinal disorders (most common AEs)
- Adverse events: assessed in all who received ≥1 dose
Original publication
Efficacy and safety of once weekly semaglutide 2·4 mg for weight management in a predominantly east Asian population with overweight or obesity (STEP 7): a double-blind, multicentre, randomised controlled trial. Lancet Diabetes Endocrinol. Published 5 February 2024. doi:10.
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