🏛️ Verified NIH Record • Updated 2026-02-10
A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756) (NCT06760546)
🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Rhythm Pharmaceuticals, Inc.
🩺 Plain-English Summary (8th-Grade Level)
This is a sub-study of Study RM-493-040 (NCT05774756). The goal of this sub-study 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 congenital Hypothalamic Obesity (cHO). To determine how well setmelanotide works and how safe it is, patients with cHO will take a daily injection of either setmelanotide or placebo and complete trial assessments for up to 26 weeks on a therapeutic regimen.
Who can join: Review the eligibility criteria below.
Location: University of Alabama — Birmingham, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (11 Sites)
- University of Alabama — Birmingham, Alabama
- Children's Hospital Colorado — Aurora, Colorado
- Lurie Children's Hospital — Chicago, Illinois
- Boston Children's Hospital — Boston, Massachusetts
- Children's Minnesota — Saint Paul, Minnesota
- Columbia University Irving Medical Center — New York, New York
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- Seattle Children's Research Institute — Seattle, Washington
- UCL Great Ormond Street Institute of Child Health — London, Greater London
- Birmingham Women and Children's Hospital NHS Trust — Birmingham, West Midlands
- Hull Royal Infirmary — Hull,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.