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A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)
NCT06760546 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Setmelanotide
Study Locations (11)
Alabama
- University of Alabama — Birmingham
Colorado
- Children's Hospital Colorado — Aurora
Illinois
- Lurie Children's Hospital — Chicago
Massachusetts
- Boston Children's Hospital — Boston
Minnesota
- Children's Minnesota — Saint Paul
New York
- Columbia University Irving Medical Center — New York
Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia
Washington
- Seattle Children's Research Institute — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2025-09-23 |
| Est. Completion | 2028-03-13 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06760546
The ClinicalTrials.gov registry entry for NCT06760546 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rhythm Pharmaceuticals, which has 33 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Hypothalamic Obesity appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06760546 reports 11 study locations spanning 11 distinct geographic areas — top geographies include Alabama, Colorado, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06760546 about?
NCT06760546 is a clinical study titled "A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)". 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 wo...
What is the current status of trial NCT06760546?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 39 participants. The study started on 2025-09-23. Estimated completion is 2028-03-13.
What conditions does trial NCT06760546 study?
This clinical trial studies the following conditions: Hypothalamic Obesity, Septo-Optic Dysplasia, Multiple Pituitary Hormone Deficiency Genetic Form, Optic Nerve Hypoplasia, Childhood-onset Combined Pituitary Hormone Deficiency. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06760546?
The interventions under investigation include: Placebo (DRUG), Setmelanotide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06760546?
This trial is sponsored by Rhythm Pharmaceuticals, which has 33 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06760546 being conducted?
This trial has 11 study locations across Alabama, Colorado, Illinois, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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