A Study of Setmelanotide in Patients With Prader-Willi Syndrome (NCT06772597) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Setmelanotide in Patients With Prader-Willi Syndrome
United States18 participantsStarted 2025-03-04
Plain-language 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.
Who can participate
Age range6 Years – 65 Years
SexALL
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Key Inclusion Criteria:
* 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.
Exclusion Criteria:
* Use of weight modulating medications
* Abnormal eGFR, ALT, AST, and bilirubin values
* Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease considered severe enough to interfere with the trial and/or confound the results.
* 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
* Hypersensitivity to setmelanotide
* Diagnosis of severe psychiatric disorders
* Pregnant and/or breastfeeding
Other protocol defined Inclusion/Exclusion criteria may apply.