A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Hypothalamic Obesity, Multiple Pituitary Hormone Deficiency Genetic Form, Septo-Optic Dysplasia, Optic Nerve Hypoplasia, Childhood-onset Combined Pituitary Hormone Deficiency, Pituitary Stalk Interruption Syndrome
In brief
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.
Key facts
- Study ID
- NCT06760546
- Run by
- Rhythm Pharmaceuticals, Inc.
- People needed
- 39
- Starts
- 2025-09-23
- Expected to finish
- 2028-03-13
- Last updated by the study team
- 2026-02-12
Who can join
Age: 4 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Alabama — Birmingham, Alabama, United States (enrolling)
- Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
- Lurie Children's Hospital — Chicago, Illinois, United States (enrolling)
- Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
- Children's Minnesota — Saint Paul, Minnesota, United States (enrolling)
- Columbia University Irving Medical Center — New York, New York, United States (enrolling)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
- Seattle Children's Research Institute — Seattle, Washington, United States (enrolling)
- UCL Great Ormond Street Institute of Child Health — London, Greater London, United Kingdom (enrolling)
- Birmingham Women and Children's Hospital NHS Trust — Birmingham, West Midlands, United Kingdom (enrolling)
- Hull Royal Infirmary — Hull, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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