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

Rhythm Pharmaceuticals

Status and phase: Invitation-only; Phase 2

Conditions: Hypothalamic Obesity

Treatments: Drug: Bivamelagon

Study type: Interventional

Funder types: Industry

Identifiers

NCT07156578

RM-MC72-002

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

25 participants in 1 patient group

Bivamelagon (open-label)

Experimental group

Treatment:

Drug: Bivamelagon