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A Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity
Sponsor: Rhythm Pharmaceuticals, Inc.
Summary
The goal of this study was to determine how well LB54640 (also known as bivamelagon) worked and how safe it was in participants with Hypothalamic Obesity (HO). The study evaluated the effect of bivamelagon on safety, weight reduction, hunger, and quality of life in participants 12 years of age and older with HO. Participants took an oral daily dose of either bivamelagon (low, middle, or high dose) or placebo through Week 14. Eligible participants who consented to continue in the study after Week 14 took an oral daily dose of bivamelagon through Week 52.
Official title: A Randomized, Placebo-controlled, Double-Blind Phase 2 Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity, With an Open-Label Extension
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2024-07-11
Completion Date
2026-02-09
Last Updated
2026-10-30
Healthy Volunteers
No
Conditions
Interventions
Bivamelagon
Oral daily administration
Placebo
Placebo matched to LB54640
Locations (10)
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
Columbia University
New York, New York, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 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