Setmelanotide in Pediatric Participants With Rare Genetic Diseases of Obesity
Completed · Phase 3
Conditions studied: Bardet-Biedl Syndrome, POMC Deficiency Obesity, PCSK1 Deficiency Obesity, LEPR Deficiency Obesity
In brief
This is a phase 3 open-label, clinical study to evaluate the efficacy, safety and tolerability of setmelanotide over 1 year of treatment, in pediatric participants aged 2 to \<6 years with obesity due to either biallelic variants of the pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) genes or Bardet-Biedl Syndrome (BBS).
Key facts
- Study ID
- NCT04966741
- Run by
- Rhythm Pharmaceuticals, Inc.
- People needed
- 12
- Starts
- 2022-03-08
- Expected to finish
- 2024-11-08
- Last updated by the study team
- 2024-11-27
Who can join
Age: 2 and older, up to 5. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Children's Hospital Colorado — Aurora, Colorado, United States
- Columbia University Medical Center, Division of Pediatric Endocrinology, Diabetes and Metabolism — New York, New York, United States
- Marshfield Clinic Research Foundation — Marshfield, Wisconsin, United States
- Sydney Children's Hospital — Randwick, Australia
- Hospital Infantil Niño Jesus — Madrid, Spain
- Addenbrooke's Hospital, Wellcome Trust-MRC Institute of Metabolic Science — Cambridge, United Kingdom
Full record on ClinicalTrials.gov
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