Open-Label Extension Study of Setmelanotide
- Conditions
- Obesity Associated With Defects in Leptin-melanocortin Pathway
- Interventions
- Registration Number
- NCT06596135
- Lead Sponsor
- Rhythm Pharmaceuticals, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 30
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Setelanotide (Open-label) Setmelanotide Once daily (QD) subcutaneous injection of setmelanotide
- Primary Outcome Measures
Name Time Method Safety and tolerability of setmelanotide assessed by frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) Up to 3 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
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