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

Phase 2

Not yet recruiting

• Conditions: LEPR Deficiency Obesity; POMC Deficiency Obesity; PCSK1 Deficiency Obesity
• Interventions: Drug: LB54640

• Registration Number: NCT06041841
• Lead Sponsor: LG Chem

Brief 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.

Study Timeline

• Study First Submitted: 2023-09-11
• Study First Submitted QC: 2023-09-11
• Study First Posted: 2023-09-18
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02
• Study Start: 2023-12
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
POMC/PCSK1/LEPR cohort	LB54640	LB54640 once daily by oral administration

Primary Outcome Measures

Name	Time	Method
Change of BMI	From baseline to Week 16

Secondary Outcome Measures

Name	Time	Method
Frequency and severity of adverse events (AE)	From first dose up to Week 52
Mean change and mean percentage change from baseline in body weight	From baseline up to Week 52
Mean change and mean percentage change from baseline in body composition assessed by dual energy x-ray absorptiometry	From baseline up to Week 52	Fat mass and lean mass will be measured through dual energy x-ray absorptiometry
Frequency and severity of adverse events of special interest (AESI)	From first dose up to Week 52
Mean change and mean percentage change from baseline in waist circumference.	From baseline up to Week 52
Mean change and mean percentage change from baseline in Hunger Questionnaire Scores	From baseline up to Week 52	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).

Trial Locations

Locations (2)

Pitié Salpêtrière hospital and Sorbonne Université; 🇫🇷 Paris, France

Cambridge university; 🇬🇧 Cambridge, United Kingdom