Efficacy and safety of once-weekly semaglutide 2·4 mg in Chinese adults with overweight or obesity (STEP 12): a randomised, double-blind, placebo-controlled, multicentre, phase 3b trial
Primary result · Percentage change in bodyweightResult — go to the resultEstimated treatment difference −9.9 percentage points 95% CI −11.8 to −8.0Authors' conclusion
Semaglutide 2.4 mg provided a superior reduction in bodyweight versus placebo in Chinese adults with overweight or obesity. The safety profile was consistent with the known profile of semaglutide.
Study context
- Population
- Adults from mainland China and Taiwan with BMI 24-<28 kg/m² and ≥1 weight-related comorbidity, or BMI 28-<30 kg/m², with or without T2D; 19 sitesrandomised 2:1
- Participants
- 242 adults
- Comparison
- Once-weekly subcutaneous semaglutide 2.4 mg vs placebo, plus lifestyle intervention, for 44 weeks
- Semaglutide 2.4 mgn = 161
- Placebon = 81reference
- Primary endpoint
- Coprimary: percentage change in bodyweight and proportion achieving ≥5% bodyweight reduction
- Follow-up
- Week 44
Methodological detailsdouble-blind, placebo-controlled, multicentre, two-armed, parallel-group, phase 3b, Conducted Sept 15, 2023, to May 7, 2025, at 19 sites across mainland China and Taiwan
- Double-blind
- Placebo-controlled
- Multicentre
- Two-armed
- Parallel-group
- Phase 3b
- Conducted Sept 15, 2023, to May 7, 2025, at 19 sites across mainland China and Taiwan
Primary result
Percentage change in bodyweight
Estimated treatment difference
−9.9 percentage points
95% CI −11.8 to −8.0
P < 0.0001
Change by group
Semaglutide 2.4 mg
−12.1
SE 0.6 · %
Placebo
−2.2
SE 0.8 · %
Semaglutide 2.4 mgvs Placebo
estimated treatment difference −9.9 percentage points (95% CI −11.8 to −8.0); P < 0.0001
As reported in the abstract
Further findings
| Outcome | Semaglutide 2.4 mg | Placebo | OR (95% CI) | P value | |
|---|---|---|---|---|---|
| Coprimary: ≥5% bodyweight reduction · week 44 | 80.5% | 24.4% | 14.8 (7.4–29.6) | P < 0.0001 | |
| 0.050.21520Odds ratio (log scale) |
Safety
Adverse events
- Adverse events: analysed descriptively in all participants who received the trial intervention
Adverse events
- Gastrointestinal disorders were the most common
Original publication
Efficacy and safety of once-weekly semaglutide 2·4 mg in Chinese adults with overweight or obesity (STEP 12): a randomised, double-blind, placebo-controlled, multicentre, phase 3b trial. Lancet Diabetes Endocrinol. Published 10 August 2026. doi:10.
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