A Phase 2 Study to Assess Efficacy and Safety of LB54640... | NCT06041841

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

NCT06041841

Sponsor

LG Chem

Status

Unknown status

Last Update Posted

Nov 2, 2023Actual

Enrollment

4Estimated

Phase

Phase 2

Conditions

POMC Deficiency Obesity
PCSK1 Deficiency Obesity
LEPR Deficiency Obesity

Interventions

LB54640

Countries

France
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2023Estimated

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Sep 11, 2023

First Submission Date that Met QC Criteria

Sep 11, 2023

First Posted Date

Sep 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2023

Last Update Posted Date

Nov 2, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
POMC/PCSK1/LEPR cohort	Experimental	LB54640 once daily by oral administration	Drug: LB54640

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LB54640	Drug	LB54640 QD Oral	POMC/PCSK1/LEPR cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of BMI		From baseline to Week 16

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
LG CHEM	Contact	+82-2-3777-1114		pathway@lgchem.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pitié Salpêtrière hospital and Sorbonne Université		Paris			France
Cambridge university

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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