Setmelanotide for Congenital Hypothalamic Obesity

This study is looking at how well Setmelanotide works to help people aged 4 and older with congenital Hypothalamic Obesity (cHO) lose weight, feel less hungry, and improve their quality of life. cHO is a type of obesity linked to certain genetic conditions like multiple pituitary hormone deficiency (MPHD) or septo-optic dysplasia (SOD). You would receive daily injections of either Setmelanotide or a placebo (an inactive substance) for up to 26 weeks. The main goal is to see how much your Body Mass Index (BMI) changes. The study is currently unclear on its recruitment status and plans to enroll 39 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It involves a comparison between Setmelanotide and a placebo in about 39 participants.
What's involved
Participants will take a daily injection of either Setmelanotide or a placebo. You will complete trial assessments for up to 26 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes after 26 weeks on a therapeutic regimen, but further follow-up is not specified.

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NCT06760546

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

Recruiting
PHASE3Ages 4+InterventionalTreatment
Rhythm Pharmaceuticals, Inc.
~39 participants
Updated 2026-02-12 on ClinicalTrials.gov
What's tested:SetmelanotidePlacebo

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean % change in BMI
Measured over From Baseline after 26 weeks on a therapeutic regimen
Hypothalamic Obesity
Multiple Pituitary Hormone Deficiency Genetic Form
Septo-Optic Dysplasia
Optic Nerve Hypoplasia
Childhood-onset Combined Pituitary Hormone Deficiency
Pituitary Stalk Interruption Syndrome
11 sites across 11 states
Alabama1
Colorado1
Illinois1
Massachusetts1
Minnesota1
New York1
Pennsylvania1
Washington1
  • David Meeker, MD · STUDY_CHAIR · Rhythm Pharmaceuticals, Inc.

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  • Mean % change in BMIFrom Baseline after 26 weeks on a therapeutic regimen