Clinical Trial

A Study of Setmelanotide in Patients With Prader-Willi Syndrome

Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
This is a Phase 2, open-label study designed to assess the safety and efficacy of setmelanotide in patients with obesity due to Prader-Willi Syndrome (PWS) who are 6 to 65 years of age. Up to 20 patients are planned to be enrolled. Patients will take a daily subcutaneous dose of open-label setmelanotide for up to 52 weeks.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2025-01-10; most recent amendment 2026-02-10.
Status change: Recruiting → Active, Not Recruiting 2026-02-10
Status change: Not Yet Recruiting → Recruiting 2025-02-26
Trial Details
NCT Number NCT06772597
Lead Sponsor Rhythm Pharmaceuticals, Inc.
Conditions Prader-Willi Syndrome, Obesity, Hyperphagia
Enrollment 18 participants
Start Date 2025-03-04
Primary Completion 2026-10-31 (estimated)
Study Completion 2027-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-12