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

Launched by LG CHEM · Sep 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called LB54640 for people who are struggling with obesity due to specific genetic conditions, namely POMC deficiency, PCSK1 deficiency, and LEPR deficiency. These conditions make it difficult for individuals to manage their weight effectively. The trial aims to see how well LB54640 works and how safe it is for patients with these rare genetic forms of obesity.

To participate in the study, individuals must be at least 12 years old and have been diagnosed with one of the mentioned genetic disorders that cause obesity. Eligible participants should have a body mass index (BMI) that indicates obesity, which is a measure of body fat based on height and weight. However, there are some restrictions; for example, people who have lost a significant amount of weight recently, undergone weight loss surgery, or have certain health conditions will not be able to join. If you decide to participate, you will be closely monitored throughout the study to assess the treatment's effectiveness and safety. This trial is not yet recruiting participants, so there will be more information available once it starts.

Gender

ALL

Eligibility 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