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
Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
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/Exclusion criteria may apply.
Primary outcome measure(s)
Safety and tolerability of bivamelagon as assessed by the number and frequency of AEs — Baseline to up to 2 years
Trial sites (9)
Facility
City
Region
Status
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
Birmingham Women's and Children's NHS Foundation Trust
Birmingham
United Kingdom
University of Cambridge
Cambridge
United Kingdom
Great Ormond Street Hospital for Children
London
United Kingdom
More Rhythm Pharmaceuticals, Inc. trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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