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

LEPR Deficiency Obesity Clinical Trial

Official title:

A Phase 2, Single-arm, Open-label Study to Assess Efficacy and Safety of LB54640 in Patients With Obesity Due to POMC, PCSK1, or LEPR Deficiency.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06041841
• Other study ID #: LG-MCCL004
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 2023
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: LG Chem
• Contact: LG CHEM
• Phone: +82-2-3777-1114
• Email: pathway[@]lgchem.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• LEPR Deficiency Obesity
• Obesity
• PCSK1 Deficiency Obesity
• POMC Deficiency Obesity

Intervention

Drug:
• LB54640
LB54640 QD Oral

Locations

Country	Name	City	State
France	Pitié Salpêtrière hospital and Sorbonne Université	Paris
United Kingdom	Cambridge university	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Countries where clinical trial is conducted

France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of BMI		From baseline to Week 16
Secondary	Frequency and severity of adverse events (AE)		From first dose up to Week 52
Secondary	Frequency and severity of adverse events of special interest (AESI)		From first dose up to Week 52
Secondary	Mean change and mean percentage change from baseline in body weight		From baseline up to Week 52
Secondary	Mean change and mean percentage change from baseline in waist circumference.		From baseline up to Week 52
Secondary	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).	From baseline up to Week 52
Secondary	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	From baseline up to Week 52