Status:
ENROLLING_BY_INVITATION
Open-Label Extension Study of Setmelanotide
Lead Sponsor:
Rhythm Pharmaceuticals, Inc.
Conditions:
Obesity Associated With Defects in Leptin-melanocortin Pathway
Eligibility:
All Genders
2+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
October 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06596135
Start Date
October 21 2024
End Date
October 30 2027
Last Update
September 4 2025
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
2
UC San Diego- Rady Children's Hospital
San Diego, California, United States, 92123
3
University of Florida at Gainesville
Gainesville, Florida, United States, 32611
4
University of Michigan
Ann Arbor, Michigan, United States, 48109