LB54640 in Patients with Obesity
Research type
Research Study
Full 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
IRAS ID
1008526
Contact name
LG Chem Clinical Research n/s
Contact email
Sponsor organisation
LG Chem, Ltd.
Clinicaltrials.gov Identifier
Research summary
Genetic obesity is related to a specific pathway in the body, called MC4R, which helps to control appetite, energy levels, and body weight. Certain specific gene mutations (changes), including those in POMC (pro-opiomelanocortin), PCSK1 (prohormone convertase 1), and LEPR (leptin receptor), have been found to alter the MC4R pathway, “turning off” the action in the brain that controls hunger and energy output, which can lead to early onset severe obesity. This study is testing a potential new medication, LB54640, to see if it is safe and effective at controlling appetite and reducing weight in participants who have these specific gene mutations by helping to activate the MC4R pathway.
A total of at least 5 participants will be enrolled onto this study at approximately 7 study centers in the European Union, United Kingdom, and United States.
The study drug LB54640 is investigational - this means that it has not yet been approved for the treatment of genetic obesity by any health authority .
Participants will sign the Informed Consent Form prior to having any study procedures. Participants taking part in the study will be in the study for about 20 weeks, this includes:
• A screening period of approximately 8 weeks
• A treatment period of 16 weeks
• A follow-up period of 4 weeks
If participants are eligible and agree to participate in a long-term extension phase, their participation in the study will last for an additional 36 weeks. Participants will be given a separate information sheet and consent form before they decide whether to take part in this extension phase.
Once Informed Consent Form has been signed, the Study Doctor will check the participants medical history. Participants have a
physical exam, blood tests and urine tests. The tests and procedures will confirm if the participant is eligible for the study.REC name
London - Harrow Research Ethics Committee
REC reference
23/LO/0954
Date of REC Opinion
19 Dec 2023
REC opinion
Further Information Favourable Opinion