Clinical trial
A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)
Invitation only Β· Phase 2 Β· 2 countries Β· Registry ID NCT07156578
Invitation onlyPhase 2Interventional
What this study is 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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age12 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionHypothalamic Obesity
Full registry 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.
Treatments and study arms
Bivamelagon
Drug
daily dose of oral bivamelagon
Primary outcomes
Safety and tolerability of bivamelagon as assessed by the number and frequency of AEsBaseline to up to 2 years
Study locations
9 locations were listed when this page was built. The first 40 are shown.
Birmingham Women's and Children's NHS Foundation Trustπ¬π§ Birmingham, United Kingdom
University of Cambridgeπ¬π§ Cambridge, United Kingdom
Great Ormond Street Hospital for Childrenπ¬π§ London, United Kingdom
Children's Hospital ColoradoπΊπΈ Aurora, Colorado, United States
Tufts Medical CenterπΊπΈ Boston, Massachusetts, United States
The University of North Carolina at Chapel HillπΊπΈ Chapel Hill, North Carolina, United States
University of Iowa Children's HospitalπΊπΈ Iowa City, Iowa, United States
St. Jude Children's Research HospitalπΊπΈ Memphis, Tennessee, United States
Columbia UniversityπΊπΈ New York, New York, United States