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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
daily dose of oral bivamelagon
Children's Hospital Colorado
Aurora, Colorado, United States
University of Iowa Children's Hospital
Iowa City, Iowa, United States
Tufts Medical Center
Boston, Massachusetts, United States
Safety and tolerability of bivamelagon as assessed by the number and frequency of AEs
Time frame: Baseline to up to 2 years
Mean change and mean percentage change from Baseline in BMI in participants ≥18 years of age.
Time frame: Baseline to up to 2 years
Mean change in BMI z-score in participants >18 years of age.
Time frame: Baseline to up to 2 years
Mean change in and mean percentage change in weight
Time frame: Baseline to up to 2 years
Mean change in percentage of the 95th percentile of BMI in participants <18 years of age.
Time frame: Baseline to up to 2 years
Percentage of patients who achieve ≥5%,≥10%, ≥15%, and ≥20% reduction in BMI from baseline
Time frame: 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
Time frame: Baseline to up to 2 years
Change from Baseline in total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides
Time frame: Baseline to up 2 years
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Columbia University
New York, New York, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, United Kingdom
University of Cambridge
Cambridge, United Kingdom
Great Ormond Street Hospital for Children
London, United Kingdom