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

LG Chem

Status and phase

Not yet enrolling

Phase 2

Conditions

PCSK1 Deficiency Obesity

POMC Deficiency Obesity

LEPR Deficiency Obesity

Treatments

Drug: LB54640

Study type

Interventional

Funder types

Industry

Identifiers

NCT06041841

LG-MCCL004

Details and patient eligibility

About

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

Full 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.

Enrollment

4 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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