A Long-Term, Open-Label Extension Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)

Rhythm Pharmaceuticals, Inc.

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

Age range: 12+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Key Inclusion Criteria: * 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 Criteria: * 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/Ex…

Interventions

Drug
Bivamelagon
daily dose of oral bivamelagon

Locations (9)

Children's Hospital Colorado
Aurora, Colorado
University of Iowa Children's Hospital
Iowa City, Iowa
Tufts Medical Center
Boston, Massachusetts
Columbia University
New York, New York
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina
St. Jude Children's Research Hospital
Memphis, Tennessee