Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07156578

A Long-Term 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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Hypothalamic Obesity Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gonadal Disorders Gonadal Dysgenesis Hypogonadism Male Urogenital Diseases Sexual Infantilism Urogenital Abnormalities Urogenital Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Birmingham Women's and Children's NHS Foundation Trust, Birmingham, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bivamelagon

Drug

daily dose of oral bivamelagon

Primary outcomes

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

    Time frame: Baseline to up to 2 years

Secondary outcomes

  1. Mean change and mean percentage change from Baseline in BMI in participants ≥18 years of age.

    Time frame: Baseline to up to 2 years

  2. Mean change in BMI z-score in participants >18 years of age.

    Time frame: Baseline to up to 2 years

  3. Mean change in and mean percentage change in weight

    Time frame: Baseline to up to 2 years

  4. Mean change in percentage of the 95th percentile of BMI in participants <18 years of age.

    Time frame: Baseline to up to 2 years

  5. Percentage of patients who achieve ≥5%,≥10%, ≥15%, and ≥20% reduction in BMI from baseline

    Time frame: Baseline to up to 2 years

  6. Mean change from Baseline in Physical function (and total score) for the Impact of Weight on Quality of Life-Lite (IWQoL) in participants ≥18 years of age

    Time frame: Baseline to up to 2 years

  7. Change from Baseline in total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides

    Time frame: Baseline to up 2 years

Sponsors and collaborators

Lead sponsor

Rhythm Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 5, 2025
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.