Trial Profile

A Phase 2, Single-center, Open-label Study of Setmelanotide in Patients With Prader-Willi Syndrome

Status: Recruiting

Phase of Trial: Phase II

Latest Information Update: 16 Feb 2026

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At a glance

Drugs Setmelanotide (Primary)
Indications Prader-Willi syndrome
Focus Adverse reactions
Sponsors Rhythm

Most Recent Events

12 Feb 2026 Actual primary completion date changed to 31 Oct 2026.
09 Jan 2026 According to a Rhythm Pharmaceuticals media release, company anticipates announcing six-month results from 18 patients from the ongoing Phase 2 trial in the first half of 2026.
11 Dec 2025 According to a Rhythm Pharmaceuticals media release, ongoing 52-week trial has enrolled 18 patients with Prader-Willi syndrome (PWS) aged 6-65 years who meet defined BMI eligibility criteria, with additional data expected in the first half of 2026.

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