[Edaily Reporter KIM SAE-MI ] JWPHARMACEUTICAL(001060)announced on the 14th that it has submitted an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety for a Phase 3 clinical trial in Korea of the obesity treatment “Bofanglutide” for adult patients who are obese or overweight.
This clinical trial will involve 300 Korean adult patients who are obese or overweight. It will be conducted as a multicenter, randomized, double-blind, placebo-controlled, parallel-group study comparing the Bofanglutide treatment group with the placebo group.
The primary endpoints are the percentage change in body weight at Week 52 compared to baseline and the proportion of subjects achieving at least a 5% reduction in body weight. The study aims to evaluate whether the Bofanglutide group demonstrates superior weight loss efficacy compared to the placebo group.
JWPHARMACEUTICAL aims to begin the clinical trial this December following IND approval, with the goal of completing it in March 2029.
A key feature of Bopanglutide is that it is being developed for once-every-two-weeks dosing. JWPHARMACEUTICAL expects that, compared to major glucagon-like peptide-1 (GLP-1) agonists currently used as obesity treatments—most of which are administered once weekly—the number of injections can be reduced from 52 to 26 per year.
A JWPHARMACEUTICAL official stated, “By demonstrating the efficacy and safety of Bopanglutide through this clinical trial, we will be able to broaden the range of treatment options for patients with obesity and provide a new therapeutic option with excellent clinical efficacy.”