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

NCT07156578 | Enrolling By Invitation Phase 2 FDA Drug

• 1 other identifier: RM-MC72-002
• Study Type: interventional
• Target: 25
• Locations: 2 countries
• Sites: 9

Brief 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.

Conditions

Hypothalamic Obesity

Outcome Measures

Primary Outcomes (1)

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

  Baseline to up to 2 years

Secondary Outcomes (7)

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

  Baseline to up to 2 years

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

  Baseline to up to 2 years

• Mean change in and mean percentage change in weight

  Baseline to up to 2 years

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

  Baseline to up to 2 years

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

  Baseline to up to 2 years

Study Arms (1)

Bivamelagon (open-label)

EXPERIMENTAL

Drug: Bivamelagon

Interventions

Bivamelagon DRUG

daily dose of oral bivamelagon

Bivamelagon (open-label)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rhythm Pharmaceuticals, Inc.: lead

Study Sites (9)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

University of Iowa Children's Hospital

Iowa City, Iowa, 52242, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Columbia University

New York, New York, 10027, United States

Location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Birmingham Women's and Children's NHS Foundation Trust

Birmingham, B15 2TG, United Kingdom

Location

University of Cambridge

Cambridge, CB2 1TN, United Kingdom

Location

Great Ormond Street Hospital for Children

London, WC1N 3JH, United Kingdom

Location

MeSH Terms

Conditions

Sexual Infantilism

Condition Hierarchy (Ancestors)

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

Study Officials

• David Meeker, MD

  Rhythm Pharmaceuticals, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 5, 2025
• Study Start: November 10, 2025
• Primary Completion (Estimated): April 15, 2028
• Study Completion (Estimated): April 15, 2028
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3); US (6)