Safety and Efficacy of LB54640 in Hypothalamic Obesity
Research type
Research Study
Full 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
IRAS ID
1008926
Contact name
LG Chem Clinical research N/A
Contact email
Sponsor organisation
LG Chem, Ltd.
Clinicaltrials.gov Identifier
Research summary
Hypothalamic obesity is a condition caused by physical damage to a part of the brain called the hypothalamus. This results in a disruption of a specific pathway in the brain, called MC4R, which helps to control appetite, energy levels, and body weight. The disrupted MC4R pathway leads to the “turning off” of an action in the brain that controls hunger and energy output (metabolism), which can contribute to increased food intake and 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 hypothalamic obesity by helping to activate the MC4R pathway.
Participants will be randomly assigned to receive either LB54640 (either 200, 400, or 600 mg/day) or placebo. Placebo looks like the study drug but contains no active medication. The study drug and placebo together will be known as “study medication” . Participants will have a 75% chance of receiving active study drug and a 25% chance of receiving placebo.
This study is "double-blinded", which means that neither the participant nor the study doctor will know which group they have been assigned to.
The study drug will be taken by mouth once a day with water, in the morning before eating. It is to be taken at the same time each day. On study visit days, the study drug will be taken in clinic, after blood sample collection.
Dosing will occur as follows during the treatment phase:
Group 1: 200mg per day for 14 weeks
Group 2: 200mg per day for 1 week, then 400mg per day for 13 weeks
Group 3: 200mg per day for 1 week, 400mg per day for 1 week, then 600mg per day for 12 weeks
Group 4: placebo for 14 weeks
If participants experience any symptoms of nausea, vomiting, diarrhoea, or loose stools, the study doctor may reduce the of study drug until those symptoms resolve.
At the end of the treatment phase, participants may be able to enter into a long-term extension phase. This will last 38 weeks.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
23/EE/0255
Date of REC Opinion
19 Feb 2024
REC opinion
Further Information Favourable Opinion