DRUG
Setmelanotide
Open-label daily injections of setmelanotide
Status
Completed
Phase
Phase 3
Enrollment
28
Locations
13
Results
Not posted
Publications
0
Study summary
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.
Interventions
DRUG
Open-label daily injections of setmelanotide
Timeline
First posted
Sep 19, 2024
Study start
Oct 21, 2024
Primary completion
Jun 24, 2026
Study completion
Jun 24, 2026
Results posted
Not reported
Registry updated
Jul 15, 2026
Outcomes
Safety and tolerability of setmelanotide assessed by frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame · Up to 3 years
Not reported in the indexed record.
Eligibility
Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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®). * Any new or worsening depression resulting in suicidal thoughts and/or behaviors. * Discontinuation from a previous setmelanotide study. * History or close family history (parents or siblings) of melanoma. * Pregnant and/or breastfeeding women Other protocol defined Inclusion/Exclusion criteria may apply.
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.