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

Not Applicable

Not yet recruiting

• Conditions: Hypothalamic Obesity
• Interventions: Drug: Bivamelagon

• Registration Number: NCT07156578
• Lead Sponsor: Rhythm Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-25
• Study First Submitted QC: 2025-08-27
• Last Update Submitted: 2025-08-27
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05
• Study Start: 2025-11-03
• Primary Completion: 2028-04-15
• Study Completion: 2028-04-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bivamelagon (open-label)	Bivamelagon	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of bivamelagon as assessed by the number and frequency of AEs	Baseline to up to 2 years

Secondary Outcome Measures

Name	Time	Method
Mean change in BMI z-score in participants >18 years of age.	Baseline to up to 2 years
Mean change and mean percentage change from Baseline in 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
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
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	Baseline to up to 2 years
Change from Baseline in total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides	Baseline to up 2 years