Efficacy and safety of once-weekly tirzepatide in Japanese patients with obesity disease (SURMOUNT-J): a multicentre, randomised, double-blind, placebo-controlled phase 3 trial
Authors' conclusion
In Japanese adults with obesity disease, tirzepatide provided clinically a meaningful reduction in bodyweight compared with placebo over 72 weeks, with a safety profile consistent with that observed in global populations.
Study context
- Population
- Japanese adults with obesity disease (BMI ≥27 kg/m² with ≥2 obesity-related health disorders or ≥35 kg/m² with ≥1), excluding diabetesModified intention-to-treat (mITT) 225
- Participants
- 267 adults
- Comparison
- Once-weekly SC tirzepatide 10 mg or 15 mg vs placebo, adjunct to lifestyle modifications
- Tirzepatide 10 mgn = 73
- Tirzepatide 15 mgn = 77
- Placebon = 75reference
- Primary endpoint
- Coprimary: mean percent change in bodyweight and proportion achieving ≥5% bodyweight reduction (efficacy estimand)
- Follow-up
- Week 72
Methodological detailsmulticentre, double-blind, placebo-controlled, phase 3
- Multicentre
- Double-blind
- Placebo-controlled
- Phase 3
Primary result
As reported in the abstract
Change in bodyweight; ≥5% bodyweight reduction
Each group vs placeboEstimated treatment difference in change in bodyweight, % (95% CI)P value
Tirzepatide 10 mg
−16.1(−18.7 to −13.5)
P < 0.0001Tirzepatide 15 mg
−21.1(−23.6 to −18.5)
P < 0.0001Further findings
Cardiometabolic and body composition indices
- Also improved with tirzepatide
Safety
Treatment-emergent adverse events
| Outcome | Tirzepatide 10 mg | Tirzepatide 15 mg | Placebo |
|---|---|---|---|
| Study discontinuation due to adverse events | 1% | 0 events | 4% |
Treatment-emergent adverse events
- Most commonly gastrointestinal symptoms
Original publication
Efficacy and safety of once-weekly tirzepatide in Japanese patients with obesity disease (SURMOUNT-J): a multicentre, randomised, double-blind, placebo-controlled phase 3 trial. Lancet Diabetes Endocrinol. Published 28 February 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →