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

NCT06041841 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: LG-MCCL004
• Study Type: interventional
• Target: 4
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

POMC Deficiency Obesity; PCSK1 Deficiency Obesity; LEPR Deficiency Obesity

Outcome Measures

Primary Outcomes (1)

• Change of BMI

  From baseline to Week 16

Secondary Outcomes (6)

• Frequency and severity of adverse events (AE)

  From first dose up to Week 52

• 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 body weight

  From baseline 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

Study Arms (1)

POMC/PCSK1/LEPR cohort

EXPERIMENTAL

LB54640 once daily by oral administration

Drug: LB54640

Interventions

LB54640 DRUG

LB54640 QD Oral

POMC/PCSK1/LEPR cohort

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• LG Chem: lead

Study Sites (2)

Pitié Salpêtrière hospital and Sorbonne Université

Paris, France

Location

Cambridge university

Cambridge, United Kingdom

Location

Central Study Contacts

LG CHEM

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a study where each participant participates for up to 56 weeks. The study consists up to 7 visits to study center which include a Screening period, treatment period, and a follow-up period. Eligible participants who are willing to enter the long-term extension period and who are judged by the study doctor to have no safety concerns, will continue to receive LB54640 at the same dose level from the treatment period. The long-term extension period will be followed by a follow-up period

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 18, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); GB (1)