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

Primary Purpose

Hypothalamic Obesity

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
LB54640
Placebo
Sponsored by
LG Chem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypothalamic Obesity

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Documented evidence of acquired hypothalamic obesity (HO) Age 12 years and older Weight gain associated with the hypothalamic injury and a BMI of ≥30 kg/m2 for patients ≥18 years of age or BMI ≥95th percentile for age and sex for patients 12 to <18 years of age Agree to use a highly effective form of contraception throughout the study and for 90 days after the study Exclusion Criteria: Weight loss >2% in the previous 2 months for patients Use of any medication that is approved to treat obesity within 3 months of first dose of study drug. History of major surgical procedure within 30 days HbA1c >10.9% Fasting glucose level >270 mg/dL Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior History or close family history of skin cancer or melanoma

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    LB54640 Low dose

    LB54640 Middle dose

    LB54640 High dose

    Placebo

    Arm Description

    Participants will be randomized to receive LB54640 low dose, middle dose, or high dose, or placebo by oral administration in a 1:1:1:1 ratio.

    Participants will be randomized to receive LB54640 low dose, middle dose, or high dose, or placebo by oral administration in a 1:1:1:1 ratio.

    Participants will be randomized to receive LB54640 low dose, middle dose, or high dose, or placebo by oral administration in a 1:1:1:1 ratio.

    Participants will be randomized to receive LB54640 low dose, middle dose, or high dose, or placebo by oral administration in a 1:1:1:1 ratio.

    Outcomes

    Primary Outcome Measures

    Change of BMI

    Secondary Outcome Measures

    Frequency and severity of adverse events (AE)
    Frequency and severity of adverse events of special interest (AESI)
    Mean change and mean percentage change from baseline in body weight
    Mean change and mean percentage change from baseline in waist circumference.
    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).
    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

    Full Information

    First Posted
    September 14, 2023
    Last Updated
    October 15, 2023
    Sponsor
    LG Chem
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06046443
    Brief Title
    A Phase 2 Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity
    Official Title
    A Randomized, Placebo-controlled, Double-Blind Phase 2 Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity, With an Open-Label Extension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 31, 2023 (Anticipated)
    Primary Completion Date
    March 31, 2025 (Anticipated)
    Study Completion Date
    March 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    LG Chem

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The goal of this trial is to determine the effect of LB54640 on weight reduction, hunger, and quality of life in patients 12 years of age and older with Hypothalamic Obesity (HO). To determine how well LB54640 works and how safe it is, patients with HO will take a daily dosing of either LB54640 or placebo and complete trial assessments for up to 56 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypothalamic Obesity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    28 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    LB54640 Low dose
    Arm Type
    Experimental
    Arm Description
    Participants will be randomized to receive LB54640 low dose, middle dose, or high dose, or placebo by oral administration in a 1:1:1:1 ratio.
    Arm Title
    LB54640 Middle dose
    Arm Type
    Experimental
    Arm Description
    Participants will be randomized to receive LB54640 low dose, middle dose, or high dose, or placebo by oral administration in a 1:1:1:1 ratio.
    Arm Title
    LB54640 High dose
    Arm Type
    Experimental
    Arm Description
    Participants will be randomized to receive LB54640 low dose, middle dose, or high dose, or placebo by oral administration in a 1:1:1:1 ratio.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will be randomized to receive LB54640 low dose, middle dose, or high dose, or placebo by oral administration in a 1:1:1:1 ratio.
    Intervention Type
    Drug
    Intervention Name(s)
    LB54640
    Intervention Description
    Oral daily administration
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo matched to LB54640
    Primary Outcome Measure Information:
    Title
    Change of BMI
    Time Frame
    From baseline to Week 14
    Secondary Outcome Measure Information:
    Title
    Frequency and severity of adverse events (AE)
    Time Frame
    From first dose up to Week 52
    Title
    Frequency and severity of adverse events of special interest (AESI)
    Time Frame
    From first dose up to Week 52
    Title
    Mean change and mean percentage change from baseline in body weight
    Time Frame
    From first dose up to Week 52
    Title
    Mean change and mean percentage change from baseline in waist circumference.
    Time Frame
    From first dose up to Week 52
    Title
    Mean change and mean percentage change from baseline in Hunger Questionnaire Scores
    Description
    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 first dose up to Week 52
    Title
    Mean change and mean percentage change from baseline in body composition assessed by dual energy x-ray absorptiometry
    Description
    Fat mass and lean mass will be measured through dual energy x-ray absorptiometry
    Time Frame
    From first dose up to Week 52

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Documented evidence of acquired hypothalamic obesity (HO) Age 12 years and older Weight gain associated with the hypothalamic injury and a BMI of ≥30 kg/m2 for patients ≥18 years of age or BMI ≥95th percentile for age and sex for patients 12 to <18 years of age Agree to use a highly effective form of contraception throughout the study and for 90 days after the study Exclusion Criteria: Weight loss >2% in the previous 2 months for patients Use of any medication that is approved to treat obesity within 3 months of first dose of study drug. History of major surgical procedure within 30 days HbA1c >10.9% Fasting glucose level >270 mg/dL Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior History or close family history of skin cancer or melanoma
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    LG CHEM
    Phone
    +82-2-3777-1114
    Email
    pathway@lgchem.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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