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

LG Chem4 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

POMC Deficiency Obesity PCSK1 Deficiency Obesity LEPR Deficiency Obesity

Interventions

LB54640DRUG

LB54640 QD Oral

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (2)

Pitié Salpêtrière hospital and Sorbonne Université

Paris, France

Cambridge university

Cambridge, United Kingdom

Outcomes

Primary Outcomes

Change of BMI

Time frame: From baseline to Week 16

Secondary Outcomes

Frequency and severity of adverse events (AE)

Time frame: From first dose up to Week 52

Frequency and severity of adverse events of special interest (AESI)

Time frame: From first dose up to Week 52

Mean change and mean percentage change from baseline in body weight

Time frame: From baseline up to Week 52

Mean change and mean percentage change from baseline in waist circumference.

Time frame: From baseline up to Week 52

Mean change and mean percentage change from baseline in Hunger Questionnaire Scores

The question will asked using the Hunger Questionnaire. The questionnaire consists of a new 5-item, patient-reported scale assessing major eating-related factors (worst and average hunger, appetite, craving, and satiety).

Time frame: From baseline up to Week 52

Mean change and mean percentage change from baseline in body composition assessed by dual energy x-ray absorptiometry

Fat mass and lean mass will be measured through dual energy x-ray absorptiometry

Time frame: From baseline up to Week 52

Central Contacts

LG CHEM

CONTACT

+82-2-3777-1114 pathway@lgchem.com

Data from ClinicalTrials.gov

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