Long Term Extension Trial of Setmelanotide
Completed · Phase 2/Phase 3
Conditions studied: Obesity Associated With Defects in Leptin-melanocortin Pathway
In brief
This was a long-term extension trial to study the safety and tolerability of continued setmelanotide treatment in participants who had completed a previous clinical trial on treatment with setmelanotide for obesity associated with genetic defects upstream of the Melanocortin-4 (MC4) receptor in the leptin-melanocortin pathway.
Key facts
- Study ID
- NCT03651765
- Run by
- Rhythm Pharmaceuticals, Inc.
- People needed
- 205
- Starts
- 2018-07-15
- Expected to finish
- 2025-01-09
- Last updated by the study team
- 2025-05-31
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Synexus Clinical Research US, Inc. - Phoenix Southeast — Chandler, Arizona, United States
- Honor Health Research Institute — Scottsdale, Arizona, United States
- San Diego Wake Research — San Diego, California, United States
- University of Florida College of Medicine — Gainesville, Florida, United States
- Baystate Medical Center — Springfield, Massachusetts, United States
- University at Buffalo — Buffalo, New York, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Wake Research — Raleigh, North Carolina, United States
- Obesity Institute, Geisinger Clinic — Danville, Pennsylvania, United States
- Childrens Hospital of Philadephia — Philadelphia, Pennsylvania, United States
- Synexus Clinical Research US, Inc.- Primary Care Associates, PC — Anderson, South Carolina, United States
- Wake Research TN — Chattanooga, Tennessee, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
- Seattle Children's Research Institute — Seattle, Washington, United States
- Marshfield Clinic Research Institute — Marshfield, Wisconsin, United States
- University of Alberta — Edmonton, Alberta, Canada
- Hôpital Trousseau — Paris, France
- Hôpital de la Pitié Salpêtrière — Paris, France
- Charité - Universitätsmedizin Berlin — Berlin, Germany
- University of Leipzig — Leipzig, Germany
- University of Ulm — Ulm, Germany
- University General Hospital of Patras — Rio, Greece
- Erasmus MC — Rotterdam, Netherlands
- Universidad Autónoma de Madrid — Madrid, Spain
- University Hospitals Birmingham NHS Foundation Trust — Birmingham, United Kingdom
Full record on ClinicalTrials.gov
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