The goal of this study is to determine how well LB54640 works and how safe it is in patients with Hypothalamic Obesity (HO). The study will evaluate the effect of LB54640 on safety, weight reduction, hunger, and quality of life in patients 12 years of age and older with HO. Patients will take an oral daily dose of either LB54640 (low, middle, or high dose) or placebo through Week 14. Eligible patients who consent to continue in the study after Week 14 will take an oral daily dose of LB54640 through Week 56.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
28
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
Mean percentage change in BMI
Time frame: From Baseline to Week 14
Frequency and severity of adverse events (AEs)
Time frame: From Baseline to Week 52
Mean change in BMI
Time frame: Baseline to Weeks 6, 10, 14
Proportion of patients who achieve ≥5% reduction in body weight
Time frame: Baseline to Week 14
Mean change in the weekly average of the daily most hunger score
Time frame: Baseline to Week 14
Mean change and mean percentage change from baseline in body weight
Time frame: From Baseline to Week 52
Mean change and mean percentage change from baseline in waist circumference.
Time frame: From Baseline to Week 52
Mean change and mean percentage change from baseline in body composition assessed by dual energy x-ray absorptiometry
Fat mass and lean mass will be measured through dual energy x-ray absorptiometry
Time frame: From Baseline to Week 52
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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
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