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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)
At a glance
Conditions
Where it's being run
11 sites across 11 statesStudy leadership
- David Meeker, MD · STUDY_CHAIR · Rhythm Pharmaceuticals, Inc.
Who to contact
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What this trial measures
- Mean % change in BMIFrom Baseline after 26 weeks on a therapeutic regimen