Trials / Active Not Recruiting
Active Not RecruitingNCT06772597
A Study of Setmelanotide in Patients With Prader-Willi Syndrome
A Phase 2 Open-label Study of Setmelanotide in Patients With Prader-Willi Syndrome
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Rhythm Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 6 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Setmelanotide | Setmelanotide (daily subcutaneous injection) |
Timeline
- Start date
- 2025-03-04
- Primary completion
- 2026-10-31
- Completion
- 2027-10-31
- First posted
- 2025-01-13
- Last updated
- 2026-02-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06772597. Inclusion in this directory is not an endorsement.