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NCT06760546 · ClinicalTrials.gov registry record · Phase 3
A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)
A Phase 3 study of Hypothalamic Obesity and Septo-Optic Dysplasia, sponsored by Rhythm Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 39
- Enrollment target
- 11
- Study locations
NCT06760546 is a Phase 3 study of Hypothalamic Obesity and Septo-Optic Dysplasia that is actively recruiting participants, run by Rhythm Pharmaceuticals. The registered enrollment target is 39 participants, below the 70-participant average among 5 other Hypothalamic Obesity trials with a reported enrollment target (44% lower). The trial reports 11 study locations across 11 states.
The verdict
NCT06760546, a Phase 3 study of Hypothalamic Obesity and Septo-Optic Dysplasia, is actively recruiting participants, sponsored by Rhythm Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 39 participants
- Enrollment target
- 11
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 70-participant average among 5 other Hypothalamic Obesity trials with a reported enrollment target (44% lower). The listed sponsor is Rhythm Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov.
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.
NCT06760546 reports 11 study locations spanning 11 distinct geographic areas - top geographies include Alabama, Colorado, Illinois.
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.
What interventions are being tested in trial NCT06760546?
The interventions under investigation include: Placebo (DRUG), Setmelanotide (DRUG).
Who is sponsoring clinical trial NCT06760546?
This trial is sponsored by Rhythm Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
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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