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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06041841
Recruitment Status : Not yet recruiting
First Posted : September 18, 2023
Last Update Posted : November 2, 2023
Sponsor:
Information provided by (Responsible Party):
LG Chem

Study Description
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Brief Summary:
The purpose of the study was to assess the efficacy of LB54640 in participants with rare genetic disorders of obesity

Condition or disease Intervention/treatment Phase
POMC Deficiency Obesity PCSK1 Deficiency Obesity LEPR Deficiency Obesity Drug: LB54640 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Estimated Study Start Date : December 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: POMC/PCSK1/LEPR cohort
LB54640 once daily by oral administration
 Drug: LB54640
LB54640 QD Oral


Outcome Measures
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Primary Outcome Measures :
  1. Change of BMI [ Time Frame: From baseline to Week 16 ]

Secondary Outcome Measures :
  1. Frequency and severity of adverse events (AE) [ Time Frame: From first dose up to Week 52 ]
  2. Frequency and severity of adverse events of special interest (AESI) [ Time Frame: From first dose up to Week 52 ]
  3. Mean change and mean percentage change from baseline in body weight [ Time Frame: From baseline up to Week 52 ]
  4. Mean change and mean percentage change from baseline in waist circumference. [ Time Frame: From baseline up to Week 52 ]
  5. Mean change and mean percentage change from baseline in Hunger Questionnaire Scores [ Time Frame: 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).

  6. Mean change and mean percentage change from baseline in body composition assessed by dual energy x-ray absorptiometry [ Time Frame: From baseline up to Week 52 ]
    Fat mass and lean mass will be measured through dual energy x-ray absorptiometry


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06041841


Contacts
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Contact: LG CHEM +82-2-3777-1114 pathway@lgchem.com

Locations
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France
Pitié Salpêtrière hospital and Sorbonne Université
Paris, France
United Kingdom
Cambridge university
Cambridge, United Kingdom
Sponsors and Collaborators
LG Chem
More Information
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Responsible Party: LG Chem
ClinicalTrials.gov Identifier: NCT06041841    
Other Study ID Numbers: LG-MCCL004
First Posted: September 18, 2023    Key Record Dates
Last Update Posted: November 2, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight