NCT07156578

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

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

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Rhythm Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Bivamelagon	daily dose of oral bivamelagon

Timeline

• Start date: 2025-11-10
• Primary completion: 2028-04-15
• Completion: 2028-04-15
• First posted: 2025-09-05
• Last updated: 2026-02-10

Locations

9 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study