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Clinical Trials in the UK / NCT07156578
Enrolling by invitation Phase 2

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

NCT07156578 · tracked via the Priya Life Science UK tracker
Sponsor
Rhythm Pharmaceuticals, Inc
Phase
Phase 2
Started
2025-11-10
Last updated
2026-02-10

Condition(s) studied

Hypothalamic Obesity

Investigational drug(s) / intervention(s)

Bivamelagon

Bivamelagon: daily dose of oral bivamelagon

Study 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

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)

FacilityCityRegionStatus
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

A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756) Recruiting
A Trial of Setmelanotide in Acquired Hypothalamic Obesity Active, not recruiting

Other trials for the same condition

A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756) Recruiting
A Trial of Setmelanotide in Acquired Hypothalamic Obesity Active, not recruiting
Official registry record

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.

View NCT07156578 on ClinicalTrials.gov ↗ ← All trials in the UK