RecruitingPhase 3NCT06760546

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

A Phase 3, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients With Acquired Hypothalamic Obesity

Sponsor

Rhythm Pharmaceuticals, Inc.

Enrollment

39 participants

Start Date

Sep 23, 2025

Study Type

INTERVENTIONAL

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

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.

Eligibility

Min Age: 4 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called Setmelanotide for people with childhood-onset combined pituitary hormone deficiency, hypothalamic obesity, and other related conditions. The study is currently recruiting participants at 11 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSetmelanotide

Solution for daily subcutaneous injection

DRUGPlacebo

Placebo matched to setmelanotide for daily subcutaneous injection

Locations(11)

University of Alabama

Birmingham, Alabama, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Lurie Children's Hospital

Chicago, Illinois, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Children's Minnesota

Saint Paul, Minnesota, United States

Columbia University Irving Medical Center

New York, New York, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Seattle Children's Research Institute

Seattle, Washington, United States

UCL Great Ormond Street Institute of Child Health

London, Greater London, United Kingdom

Birmingham Women and Children's Hospital NHS Trust

Birmingham, West Midlands, United Kingdom

Hull Royal Infirmary

Hull, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06760546

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