Clinical Trial

A Trial of Setmelanotide in Acquired Hypothalamic Obesity

Active, Not Recruiting Phase 3
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Summary
The goal of this trial is to learn how well Setmelanotide works to improve weight reduction, hunger, and quality of life in patients 4 years of age and older with acquired Hypothalamic Obesity (HO). To determine how well setmelanotide works and how safe it is, patients with HO will take a daily injection of either setmelanotide or placebo and complete trial assessments for 52 weeks on a therapeutic regimen. A separate sub-study in patients with congenital HO is detailed under NCT06760546.
Protocol Amendment History 34 amendments
This ClinicalTrials.gov record has been amended 34 times since 2023-03-16; most recent amendment 2026-05-04.
Status change: Enrolling by Invitation → Active, Not Recruiting 2025-02-11
Status change: Recruiting → Enrolling by Invitation 2024-01-02
Trial Details
NCT Number NCT05774756
Lead Sponsor Rhythm Pharmaceuticals, Inc.
Conditions Hypothalamic Obesity
Enrollment 143 participants
Start Date 2023-04-26
Primary Completion 2025-03-18 (estimated)
Study Completion 2027-04-16 (estimated)
Updated on ClinicalTrials.gov 2026-08-10