Status:
ENROLLING_BY_INVITATION
A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)
Lead Sponsor:
Rhythm Pharmaceuticals, Inc.
Conditions:
Hypothalamic Obesity
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
This is a long-term, open-label extension study of bivamelagon in participants with Hypothalamic Obesity (HO) who have transitioned from the index study, LG-MCCL005. The study will last up to 2 years.
Eligibility Criteria
Inclusion
- Key
- Completed LG-MCCL005 and participant demonstrated adequate safety and tolerability in that study as determined by the Investigator.
- Agree to use a highly effective form of contraception and follow contraception requirements throughout the study and for 90 days after.
- Key
Exclusion
- Willing to remain off of: CYP3A4 inhibitors, strong CYP3A4 inducers, and P-glycoprotein inhibitors or substrates for the duration of the study.
- In the opinion of the Investigator, participant is not suitable to participate in the study.
- Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
November 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 15 2028
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT07156578
Start Date
November 10 2025
End Date
April 15 2028
Last Update
November 13 2025
Active Locations (9)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
2
University of Iowa Children's Hospital
Iowa City, Iowa, United States, 52242
3
Tufts Medical Center
Boston, Massachusetts, United States, 02111
4
Columbia University
New York, New York, United States, 10027