NCT06772597Active, not recruitingPhase 2
A Study of Setmelanotide in Patients With Prader-Willi Syndrome
A Phase 2 Open-label Study of Setmelanotide in Patients With Prader-Willi Syndrome
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 18 (actual)
- First submitted
- 10 Jan 2025
- Start date
- 4 Mar 2025
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Rhythm Pharmaceuticals, Inc.
- Diseases
- Obesity
- NCT number
- NCT06772597
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 18
- From 4 Mar 2025 to the primary completion date, 31 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of weight modulating medications
- Participation in any clinical trial with an investigational drug/device within 3 months or 5 half-lives, whichever is longer, prior to the first trial dose
Other illness
- Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease considered severe enough to interfere with the trial and/or confound the results.
- Hypersensitivity to setmelanotide
- Diagnosis of severe psychiatric disorders
Lab values
- Abnormal eGFR, ALT, AST, and bilirubin values
Other
- Pregnant and/or breastfeeding
- Other protocol defined Inclusion/Exclusion criteria may apply.
Who the study is looking for
- Confirmed diagnosis of Prader-Willi Syndrome (PWS)
- Age 6 to 65
- BMI ≥30 kg/m2 for patients ≥18 years of age or BMI ≥95th Percentile for age and sex
- Agree to use a highly effective form of contraception and follow the study contraception requirements throughout study duration and for 90 days after.
- Patient and/or guardian is able to communicate well with the Investigator, understand and comply with the requirements of the study, and understand English and sign the written informed consent.
Age in the registry: 6 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.