Actively Recruiting
Phase 3 Study of Setmelanotide Injections to Treat Congenital Hypothalamic Obesity in Patients Aged 4 and Older
Led by Rhythm Pharmaceuticals, Inc. · Updated on 2026-02-12
39
Participants Needed
11
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying how well setmelanotide works to reduce weight, hunger, and improve quality of life in patients aged 4 years and older with congenital Hypothalamic Obesity cHO. This phase 3 trial evaluates the safety and effectiveness of setmelanotide compared to placebo in this population. Participants have specific diagnoses related to hypothalamic injury and hormone deficiencies, with elevated body mass index BMI or BMI percentiles as criteria. Participants will receive a daily subcutaneous injection of either setmelanotide or a placebo in a randomized 21 ratio. The treatment period lasts for 26 weeks on a therapeutic regimen. The study is double-blind and placebo-controlled to objectively assess the effects of setmelanotide on weight and hunger measures. During the trial, participants will complete assessments measuring changes in BMI, hunger scores, weight, and quality of life related to weight impact. Safety will be monitored by tracking adverse events throughout the 26-week period. Additional evaluations include changes in BMI z-scores for pediatric patients and physical functioning scores. The trial is sponsored by Rhythm Pharmaceuticals, Inc. and will follow participants from baseline through the 26-week treatment duration.
CONDITIONS
Brief Title
A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)
Research Team
R
Rhythm Clinical Trials
P
Physician Inquiry Clinical Trials
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