Clinical TrialJul 8, 2026, 05:08 PM
Rhythm Pharma's setmelanotide Phase 3 results published in NEJM
AI Summary
Rhythm Pharmaceuticals announced the publication of positive Phase 3 TRANSCEND trial results for setmelanotide in The New England Journal of Medicine. The study demonstrated robust improvements in weight and hunger in adult and pediatric patients with acquired hypothalamic obesity. This follows recent FDA and EMA approvals for setmelanotide (IMCIVREE®) as the first and only therapy for this condition in adults and children aged four years and older.
Key Highlights
- Phase 3 TRANSCEND trial results for setmelanotide published in The New England Journal of Medicine.
- Setmelanotide achieved a -19.8% placebo-adjusted difference in body mass index (BMI) reduction.
- Mean BMI reduction of -16.5% from baseline for setmelanotide patients vs. +3.3% for placebo at 52 weeks (p<0.0001).
- 80% of patients on setmelanotide achieved a BMI reduction of 5% or greater at 52 weeks.
- Clinically meaningful improvements in hunger were observed in patients treated with setmelanotide.
- Setmelanotide (IMCIVREE®) received U.S. FDA approval in March 2026 for acquired hypothalamic obesity.
- European Medicines Agency (EMA) recommended marketing authorization for IMCIVREE in March 2026.
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