Status: Recruiting
A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)
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.
Participants needed: 39
Trial details
Phase: Phase 3Age: 4+Biological sex: AllType: InterventionalSponsor: Rhythm Pharmaceuticals, Inc.Updated: Feb 12, 2026Locations: 11
Eligibility criteria
Diagnosis of multiple pituitary hormone deficiency (MPHD), or septo-optic dyspla... [+3]
Diagnosis of Prader-Willi syndrome (PWS) or Rapid-onset obesity with hypoventila... [+11]