Enrolling by invitation NCT07156578
A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bivamelagon.
- Who it may be relevant to
- Registry conditions: Hypothalamic Obesity. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Long-Term, Open-Label Extension Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)
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.
Interventions
- Drug Bivamelagon
daily dose of oral bivamelagon
Primary outcome measures
- Safety and tolerability of bivamelagon as assessed by the number and frequency of AEs [Time frame: Baseline to up to 2 years]
Secondary outcome measures (7)
- 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]
Eligibility criteria
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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 6 centers
- Children's Hospital Colorado — Aurora
- University of Iowa Children's Hospital — Iowa City
- Tufts Medical Center — Boston
- Columbia University — New York
- The University of North Carolina at Chapel Hill — Chapel Hill
- St. Jude Children's Research Hospital — Memphis
United Kingdom · 3 centers
- Birmingham Women's and Children's NHS Foundation Trust — Birmingham
- University of Cambridge — Cambridge
- Great Ormond Street Hospital for Children — London
Identifiers
NCT: NCT07156578 · RM-MC72-002