Clinical trial
A Study of Setmelanotide in Patients With Prader-Willi Syndrome
Active, not recruiting · Phase 2 · 1 countries · Registry ID NCT06772597
Active, not recruitingPhase 2Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age6 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionPrader-Willi Syndrome, Obesity, Hyperphagia
Full registry criteria
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.
Treatments and study arms
Setmelanotide
Drug
Setmelanotide (daily subcutaneous injection)
Primary outcomes
Frequency and severity of adverse events (AEs)Baseline to Week 52
Study locations
1 locations were listed when this page was built. The first 40 are shown.
University of Florida🇺🇸 Gainesville, Florida, United States