Overview
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.
Principal investigator
Eligibility 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.
* 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.
For Referring Providers
Do you have a patient you think would be a good candidate for this trial? Learn more about enrolling your patient.