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

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

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

Eligibility basics and study details

Study type

Interventional

Phase

Phase 3

Ages

4 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

Rhythm Pharmaceuticals, Inc.

Last updated on ClinicalTrials.gov

February 12, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites