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

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LG Chem

Criteria

Inclusion Criteria:

• Participants aged ≥12 years at the time of enrollment and diagnosed with genetic obesity due to POMC, PCSK1, or LEPR deficiency mutations.

• Obesity is defined as BMI ≥30 kg/m2 for participants ≥18 years of age or BMI ≥95th percentile for age and gender for participants <18 years of age.

Exclusion Criteria:

• Participants with recent (within 2 months, prior to Screening and up to enrollment) intensive diet/exercise regimen that resulted in >2% weight loss, use of medication to treat obesity (within 3 months of first dose of LB54640 with certain exceptions), or weight loss surgery within 6 months prior to Screening or prior surgery which resulted in >10% weight loss with no evidence of weight regain are excluded

• History of major surgical procedure

• Weight loss surgery within the previous 6 months

• Any history of a suicide attempt, or any suicidal behavior

• HbA1c >10.9%

• Fasting glucose level >270 mg/dL