Hypothalamic Obesity
Conditions
Brief summary
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
DRUGBivamelagon
daily dose of oral bivamelagon
Sponsors
Rhythm Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of bivamelagon as assessed by the number and frequency of AEs | Baseline to up to 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Mean change and mean percentage change from Baseline in BMI in participants ≥18 years of age. | Baseline to up to 2 years |
| Mean change in BMI z-score in participants >18 years of age. | Baseline to up to 2 years |
| Mean change in and mean percentage change in weight | Baseline to up to 2 years |
| Mean change in percentage of the 95th percentile of BMI in participants <18 years of age. | Baseline to up to 2 years |
| Percentage of patients who achieve ≥5%,≥10%, ≥15%, and ≥20% reduction in BMI from baseline | 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 | Baseline to up to 2 years |
| Change from Baseline in total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides | Baseline to up 2 years |
Countries
United Kingdom, United States
Contacts
STUDY_CHAIRDavid Meeker, MD
Rhythm Pharmaceuticals, Inc.
Outcome results
None listed