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Enrolling by invitationPhase 2

Long-Term Study of Bivamelagon in Hypothalamic Obesity

Tests bivamelagon, a long-term extension, in people with hypothalamic obesity who joined a prior study.

Plain-language title generated from the registry record
Registry title: A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)

Key facts

Where
Birmingham, Cambridge, and London, United KingdomSee the 3 sites
Phase
Phase 2

Where in United Kingdom

  • Birmingham Women's and Children's NHS Foundation TrustBirmingham, United KingdomNo longer taking part
  • University of CambridgeCambridge, United KingdomNo longer taking part
  • Great Ormond Street Hospital for ChildrenLondon, United KingdomNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Rhythm Pharmaceuticals, Inc.
Trial code
NCT07156578
Record updated
10 February 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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.

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.

ClinicalTrials.gov NCT07156578