NCT06041841

A Phase 2 Study to Assess Efficacy and Safety of LB54640 in Patients With Genetic Obesity

A Phase 2, Single-arm, Open-label Study to Assess Efficacy and Safety of LB54640 in Patients With Obesity Due to POMC, PCSK1, or LEPR Deficiency.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (estimated)
• Sponsor: LG Chem · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study was to assess the efficacy of LB54640 in participants with rare genetic disorders of obesity

Detailed description

Patients with obesity due to POMC, PCSK1 or LEPR deficiency will be enrolled to receive LB54640 by oral administration for 16 weeks. After 16 weeks of treatment, the participant may enter a long term extension phase and receive treatment for up to 1 year.

Conditions

• POMC Deficiency Obesity
• PCSK1 Deficiency Obesity
• LEPR Deficiency Obesity

Interventions

Type	Name	Description
DRUG	LB54640	LB54640 QD Oral

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2023-09-18
• Last updated: 2023-11-02

Locations

2 sites across 2 countries: France, United Kingdom

Regulatory

• FDA-regulated drug study