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NCT05774756 · ClinicalTrials.gov registry record · Phase 3
A Trial of Setmelanotide in Acquired Hypothalamic Obesity
A Phase 3 study of Hypothalamic Obesity, sponsored by Rhythm Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT05774756: Active Phase 3 study of Hypothalamic Obesity, sponsored by Rhythm Pharmaceuticals.
NCT05774756 is a Phase 3 study of Hypothalamic Obesity that is active but no longer recruiting, run by Rhythm Pharmaceuticals. The registered enrollment target is 120 participants, above the 54-participant average among 5 other Hypothalamic Obesity trials with a reported enrollment target (122% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05774756, a Phase 3 study of Hypothalamic Obesity, is active but no longer recruiting, sponsored by Rhythm Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this trial 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 acquired Hypothalamic Obesity (HO). To determine how well setmelanotide works and how safe it is, patients with HO will take a daily injection of either setmelanotide or placebo and complete trial assessments for 52 weeks on a therapeutic regimen. A separate sub-study in patients with congenital HO is detailed under NCT06760546.
Primary Outcome
BMI was calculated as weight (kg)/height (m\^2). Least square (LS) mean and standard error (SE) were calculated using analysis of covariance (ANCOVA) model.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Setmelanotide
Study Locations (20)
Other
- Universitaetsklinikum Hamburg-Eppendorf (UKE) - Ambulanzzentrum des UKE GmbH - Hamburg
- Medicover Neuroendokrinologie - München
- University Children's Hospital, Klinikum Oldenburg - Oldenburg
Massachusetts
- Boston Children's Hospital - Boston
- Brigham and Women's Hospital - Boston
New York
- Icahn School of Medicine at Mount Sinai - New York
- Columbia University Irving Medical Center - New York
Alabama
- UAN Pediatric Endocrinology - Birmingham
California
- Rady Children's Hospital - San Diego
Colorado
- Children's Hospital Colorado - Aurora
Florida
- University of Florida - Gainesville
Illinois
- Ann and Robert H. Lurie Children's Hospital - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-04-26 |
| Est. Completion | 2027-04-16 |
| Phase | Phase 3 |
What the registry record for NCT05774756 still lists
NCT05774756 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 54-participant average among 5 other Hypothalamic Obesity trials with a reported enrollment target (122% higher).
The record links to 1 condition, with Hypothalamic Obesity appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05774756 names 20 study sites across 16 states, led by Other, Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT05774756 about?
NCT05774756 is a clinical study titled "A Trial of Setmelanotide in Acquired Hypothalamic Obesity". The goal of this trial 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 acquired Hypothalamic Obesity (HO). To determine how well setmelanotide works and how safe it is, patients with HO will take a daily inje...
What is the current status of trial NCT05774756?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2023-04-26. Estimated completion is 2027-04-16.
What conditions does trial NCT05774756 study?
This clinical trial studies the following conditions: Hypothalamic Obesity.
What interventions are being tested in trial NCT05774756?
The interventions under investigation include: Placebo (DRUG), Setmelanotide (DRUG).
Who is sponsoring clinical trial NCT05774756?
This trial is sponsored by Rhythm Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05774756 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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