Open-Label Extension Study of Setmelanotide
Completed · Phase 3
Conditions studied: Obesity Associated With Defects in Leptin-melanocortin Pathway
In brief
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.
Key facts
- Study ID
- NCT06596135
- Run by
- Rhythm Pharmaceuticals, Inc.
- People needed
- 28
- Starts
- 2024-10-21
- Expected to finish
- 2026-06-24
- Last updated by the study team
- 2026-07-15
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- HonorHealth Research Institute — Scottsdale, Arizona, United States
- UC San Diego- Rady Children's Hospital — San Diego, California, United States
- University of Florida at Gainesville — Gainesville, Florida, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Mayo Clinic - Rochester — Rochester, Minnesota, United States
- Children's Minnesota — Saint Paul, Minnesota, United States
- University of Buffalo — Getzville, New York, United States
- M3 Wake Research, Inc — Raleigh, North Carolina, United States
- Geisinger Health System — Danville, Pennsylvania, United States
- WR-ClinSearch — Chattanooga, Tennessee, United States
- Vanderbilt University School of Medicine — Nashville, Tennessee, United States
- Seattle Children's Research Institute — Seattle, Washington, United States
- Marshfield Clinical Research Institute — Marshfield, Wisconsin, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.