drugset / Trial / NCT06760546

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

NCT06760546

Phase 3 Recruiting 39 enrolled Rhythm Pharmaceuticals, Inc.
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2025-09-23
Primary completion
2027-03-13
Completion
2028-03-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Setmelanotide Protein / enzyme biologic Subcutaneous