By InvitationPhase 2

A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)

United States25 participantsStarted 2025-11-10

Plain-language 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.

Who can participate

Age range12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Safety and tolerability of bivamelagon as assessed by the number and frequency of AEs

Timeframe: Baseline to up to 2 years

Trial details

NCT IDNCT07156578

SponsorRhythm Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-04-15

View on ClinicalTrials.gov More Hypothalamic Obesity trials