NCT06596135CompletedPhase 3
Open-Label Extension Study of Setmelanotide
Open-Label Extension Study of Setmelanotide in Patients With a Rare Genetic, Syndromic or Acquired Disease of the MC4R Pathway
Source: ClinicalTrials.gov · Last updated 15 Jul 2026
Brief summary (registry, in English)
This is an open-label extension study designed to evaluate the long-term safety and tolerability of continued setmelanotide treatment in male and female patients ≥2 years of age who have completed or transitioned from a previous study with setmelanotide for rare genetic, syndromic, or acquired diseases of obesity upstream of the MC4R pathway.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 28 (actual)
- First submitted
- 10 Sept 2024
- Start date
- 21 Oct 2024
- Primary completion date
- 24 Jun 2026
- Lead sponsor
- Rhythm Pharmaceuticals, Inc.
- Diseases
- Obesity
- NCT number
- NCT06596135
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 28
- From 21 Oct 2024 to the primary completion date, 24 Jun 2026
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Discontinuation from a previous setmelanotide study.
Other illness
- Any gene variant, syndromic, or acquired disease for which setmelanotide is currently approved in the United States (i.e., patients eligible for commercial setmelanotide (IMCIVREE®).
Other
- Any new or worsening depression resulting in suicidal thoughts and/or behaviors.
- History or close family history (parents or siblings) of melanoma.
- Pregnant and/or breastfeeding women
- Other protocol defined Inclusion/Exclusion criteria may apply.
Who the study is looking for
- Males and females ≥2 years of age who have completed a previous setmelanotide clinical study and who have a condition or indication for which Rhythm plans further clinical development.
- Agree to use a highly effective form of contraception and follow the study contraception requirements throughout study duration and for 90 days after.
- Demonstrated clinical benefit in the previous setmelanotide study, as determined by the Investigator.
Age in the registry: 2 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| WR-ClinSearch Coordinator of this site? Confirm its status | Chattanooga | United States | Unknown status |
| Geisinger Health System Coordinator of this site? Confirm its status | Danville | United States | Unknown status |
| University of Florida at Gainesville Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| University of Buffalo Coordinator of this site? Confirm its status | Getzville | United States | Unknown status |
| Marshfield Clinical Research Institute Coordinator of this site? Confirm its status | Marshfield | United States | Unknown status |
| Vanderbilt University School of Medicine Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| M3 Wake Research, Inc. Coordinator of this site? Confirm its status | Raleigh | United States | Unknown status |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Children's Minnesota Coordinator of this site? Confirm its status | Saint Paul | United States | Unknown status |
| UC San Diego- Rady Children's Hospital Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| HonorHealth Research Institute Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| Seattle Children's Research Institute Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.