DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway
Completed · Phase 2 · Has a placebo group
Conditions studied: Genetic Obesity
In brief
The purpose of this study was to evaluate the safety and efficacy of once daily subcutaneous (SC) administration of setmelanotide in participants with obesity and specific gene variants in the MC4R pathway.
Key facts
- Study ID
- NCT04963231
- Run by
- Rhythm Pharmaceuticals, Inc.
- People needed
- 164
- Starts
- 2021-11-30
- Expected to finish
- 2024-09-30
- Last updated by the study team
- 2025-07-02
Who can join
Age: 6 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
Where it is running
- HonorHealth Bariatric Center — Scottsdale, Arizona, United States
- InQuest Medical Reseacrh — Suwanee, Georgia, United States
- UMass Memorial Medical Center — Worcester, Massachusetts, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Metro Detroit Endocrinology Center — Dearborn, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Mississippi Center for Advanced Medicine — Madison, Mississippi, United States
- Mount Sinai — New York, New York, United States
- Columbia University — New York, New York, United States
- Ten's Medical Center - Pediatric Endocrinology Clinic — Staten Island, New York, United States
- University of North Carolina — Chapel Hill, North Carolina, United States
- Geisinger Clinic — Danville, Pennsylvania, United States
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- Texas Tech — Amarillo, Texas, United States
- Endocrine Associates of Dallas and Plano — Dallas, Texas, United States
- Hector Granados PA — El Paso, Texas, United States
- Texas Children's Hospital — Houston, Texas, United States
- Accurate Clinical Research — Houston, Texas, United States
- Rio Grande Valley Endocrine Center — McAllen, Texas, United States
- Clinical Trials of Texas — San Antonio, Texas, United States
- Javara Research — The Woodlands, Texas, United States
- University of Alberta — Edmonton, Alberta, Canada
- Charite - Universitatsmedizin Berlin — Berlin, Germany
- Universitaetsklinikum Leipzig — Leipzig, Germany
- Universitaetsklinikum Ulm — Ulm, Germany
Full record on ClinicalTrials.gov
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