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A Trial of Setmelanotide in Acquired Hypothalamic Obesity
NCT05774756 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05774756
The ClinicalTrials.gov registry entry for NCT05774756 describes a study currently listed as active not 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 120 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 1 condition, 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: NCT05774756 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Other, Massachusetts, New York. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05774756?
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 NCT05774756?
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 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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