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
Authors' conclusion
In this Asian population with obesity (BMI ≥25.0 kg/m2), once-weekly semaglutide 2.4 mg significantly reduced bodyweight and was well tolerated. The results have meaningful clinical and policy implications for Asian countries, where lower BMI thresholds are used to define obesity compared with other populations. The efficacy and safety of semaglutide 2.4 mg support its inclusion in local treatment guidelines. These findings might also inform reimbursement policies and national obesity strategies, highlighting the importance of population-specific approaches.
Study context
- Population
- Adults of Asian descent with obesity (BMI ≥25 kg/m²), without diabetes, South Korea and Thailand; 74% female, mean age 39 years, mean BMI 31.3 kg/m²randomised 2:1
- Participants
- 150 adults
- Comparison
- Once-weekly subcutaneous semaglutide 2.4 mg vs placebo, with lifestyle interventions
- Semaglutide 2.4 mgn = 101
- Placebon = 49reference
- Primary endpoint
- Coprimary: percentage bodyweight change and proportion reaching ≥5% bodyweight reduction
- Follow-up
- Week 44
Methodological detailsdouble-blind, placebo-controlled, phase 3, 12 clinical sites
- Double-blind
- Placebo-controlled
- Phase 3
- 12 clinical sites
Primary result
As reported in the abstract
| Group | Value | ≥5% bodyweight reduction |
|---|---|---|
| Semaglutide 2.4 mg | mean −16.0 (SE 0.7) % | 96 [96%] |
| Placebo | mean −3.1 (SE 0.9) % | 12 [25%] |
Value
≥5% bodyweight reduction
- Semaglutide 2.4 mg vs Placebo: P < 0.0001 — Bodyweight change
- Semaglutide 2.4 mg vs Placebo: P < 0.0001 — ≥5% bodyweight reduction
Secondary outcomes
≥10% bodyweight reduction · week 44
P < 0.0001
≥15% bodyweight reduction · week 44
P < 0.0001
Mean, cm
| Outcome | Semaglutide 2.4 mg | Placebo | P value |
|---|---|---|---|
| Change in waist circumference · week 44 | −11.9 (SE 0.7) | −3.0 (SE 1.0) | P < 0.0001 |
Safety
Adverse events
Serious adverse events
Treatment discontinuation before week 44
Adverse events
- Gastrointestinal AEs most common with semaglutide
Original publication
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