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

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2025-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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POMC Deficiency Obesity PCSK1 Deficiency Obesity LEPR Deficiency Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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POMC/PCSK1/LEPR cohort

LB54640 once daily by oral administration

Group Type EXPERIMENTAL

LB54640

Intervention Type DRUG

LB54640 QD Oral

Interventions

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LB54640

LB54640 QD Oral

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No