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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-11

Study Completion Date

2026-01-31

Brief Summary

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The goal of this study is to determine how well LB54640 works and how safe it is in patients with Hypothalamic Obesity (HO). The study will evaluate the effect of LB54640 on safety, weight reduction, hunger, and quality of life in patients 12 years of age and older with HO. Patients will take an oral daily dose of either LB54640 (low, middle, or high dose) or placebo through Week 14. Eligible patients who consent to continue in the study after Week 14 will take an oral daily dose of LB54640 through Week 56.

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Detailed Description

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Conditions

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Hypothalamic Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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LB54640 Low dose

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.

Group Type EXPERIMENTAL

LB54640

Intervention Type DRUG

Oral daily administration

LB54640 Middle dose

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.

Group Type EXPERIMENTAL

LB54640

Intervention Type DRUG

Oral daily administration

LB54640 High dose

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.

Group Type EXPERIMENTAL

LB54640

Intervention Type DRUG

Oral daily administration

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matched to LB54640

Open-label LB54640

Eligible participants who provide consent to continue into the open-label portion of the study will receive open-label LB54640.

Group Type EXPERIMENTAL

LB54640

Intervention Type DRUG

Oral daily administration

Interventions

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LB54640

Oral daily administration

Intervention Type DRUG

Placebo

Placebo matched to LB54640

Intervention Type DRUG

Eligibility Criteria

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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 \<18 years of age
* Male and female participants agree to follow study contraception requirements and 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 3 months for patients ≥18 years of age or \>2% reduction in BMI for patients \<18 years of age
* History of major surgical procedure within 30 days
* HbA1c \>10.9%
* Fasting glucose level \>270 mg/dL
* Previous use of MC4R agonists
* Diagnosis of Prader-Willi syndrome (PWS) or Rapid-onset obesity with hypoventilation, hypothalamic, autonomic dysregulation, neuroendocrine tumor syndrome (ROHHADNET).
* Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior
* History or close family history of skin cancer or melanoma
* Current clinically significant pulmonary, cardiac, or oncologic disease considered severe enough to interfere with the study and/or confound the results

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No