🏛️ Verified NIH Record • Updated 2026-02-10
A Study of Setmelanotide in Patients With Prader-Willi Syndrome (NCT06772597)
A Phase 2 Open-label Study of Setmelanotide in Patients With Prader-Willi Syndrome
🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Rhythm Pharmaceuticals, Inc.
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Florida — Gainesville, Florida
Age range: 6 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- University of Florida — Gainesville, Florida
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Prader-Willi Syndrome
- A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS — Palo Alto, California
- Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome — Orange, California
- A Study of Pitolisant in Patients With Prader-Willi Syndrome — Los Angeles, California
- Tirzepatide in PWS, HO and GNSO — Saint Paul, Minnesota
- Regulating Together for Prader-Willi Syndrome: A Group Behavioral Therapy for Emotion Dysregulation — Kansas City, Missouri
Explore by condition: All Prader-Willi Syndrome clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.