Clinical Trial

A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)

Recruiting Phase 3
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Summary
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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2024-12-31; most recent amendment 2026-02-10.
Status change: Not Yet Recruiting → Recruiting 2025-08-19
Trial Details
NCT Number NCT06760546
Lead Sponsor Rhythm Pharmaceuticals, Inc.
Conditions Hypothalamic Obesity, Multiple Pituitary Hormone Deficiency Genetic Form, Septo-Optic Dysplasia, Optic Nerve Hypoplasia, Childhood-onset Combined Pituitary Hormone Deficiency, Pituitary Stalk Interruption Syndrome
Enrollment 39 participants
Start Date 2025-09-23
Primary Completion 2027-03-13 (estimated)
Study Completion 2028-03-13 (estimated)
Updated on ClinicalTrials.gov 2026-02-12