A Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity
Market
0.0%
Details
- Resolved Date
- 7/9/25
- Study Completion
- 2/9/26
- Company
- Rhythm Pharmaceuticals, Inc.
- Ticker
- RYTM
- Type
- Trial Status
- Completed
- Trial Size
- 28
- Volume
- $0
- NCT
- NCT06046443
- Drug Description
- 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.
Resolution Evidence
- Outcome
- YES
- Status
- Resolved
- Settlement Date
- 4/1/26 UTC
- Executive Summary
Rhythm publicly reported positive topline results for this exact Phase 2 trial of bivamelagon (formerly LB54640) in acquired hypothalamic obesity, stating it achieved statistically significant, clinically meaningful BMI reductions at Week 14 and planned End-of-Phase 2 regulatory interactions.
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