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MinorTrial status: Recruiting to Active, Not RecruitingEnrollment target: estimated 20 to confirmed 18 · Site details revised · Eligibility criteria shortened, about 1 wordv7Show 3 more changesShow less
NotablePrimary completion date: Jan 31, 2026 to Oct 31, 2026Completion date: Jan 31, 2026 to Oct 31, 2027 · Secondary endpoints: details revised at 6 of 6 entries · Study title shortened, about 1 wordv6Show 3 more changesShow less
Completion date: Jan 31, 2026 to Oct 31, 2027
Secondary endpoints: details revised at 6 of 6 entries
MinorStart date changed from estimate of Mar 3, 2025 to Mar 4, 2025v4
NotableTrial status: Not Yet Recruiting to RecruitingSite details revisedv3Show 1 more changeShow less
Site details revised
MinorStart date: Feb 7, 2025 to Mar 3, 2025v2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.