NCT06046443

A Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Rhythm Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hypothalamic Obesity

Interventions

Type	Name	Description
DRUG	LB54640	Oral daily administration
DRUG	Placebo	Placebo matched to LB54640

Timeline

• Start date: 2024-07-11
• Primary completion: 2026-02-09
• Completion: 2026-02-09
• First posted: 2023-09-21
• Last updated: 2026-02-12

Locations

10 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study