China Phase 3 trial showed up to 18.54% weight loss after 52 weeks
JW Pharmaceutical has moved a step closer to developing a next-generation obesity treatment with a less frequent dosing schedule.
The company said Tuesday that it has submitted an Investigational New Drug (IND) application to South Korea’s Ministry of Food and Drug Safety for a Phase 3 clinical trial of bofanglutide, a GLP-1 receptor agonist being developed as an obesity treatment.
The Korean trial will enroll 300 adults who are obese or overweight. JW Pharmaceutical plans to begin the study in December and evaluate the drug’s efficacy and safety against placebo through March 2029.
Bofanglutide was licensed exclusively to JW Pharmaceutical in April from China-based Gan & Lee Pharmaceuticals for development and commercialization in South Korea. The drug activates GLP-1 receptors, stimulating insulin secretion and slowing gastric emptying to increase satiety and help reduce appetite and body weight.
One of its key potential advantages is its dosing schedule. Unlike many currently marketed GLP-1 obesity treatments that are administered once a week, bofanglutide is being developed as a subcutaneous injection given once every two weeks.
If approved, the biweekly regimen could reduce the number of annual injections from 52 to 26, potentially improving treatment convenience and patient adherence.
The candidate has already demonstrated weight-loss potential in a Phase 3 study conducted in China. In the GRADUAL-1 trial, patients receiving bofanglutide for 52 weeks experienced weight reductions of 15.12% in the 24 mg group and 18.54% in the 48 mg group from baseline, with the company reporting favorable tolerability.
The global obesity-drug market is becoming increasingly competitive as GLP-1 therapies gain wider adoption. While weight-loss efficacy remains a key factor, the industry is also paying greater attention to dosing frequency, convenience and long-term treatment adherence.
JW Pharmaceutical plans to use the Korean Phase 3 program to further validate bofanglutide’s clinical benefits and safety in local patients. The company is also considering additional Phase 3 trials for indications beyond obesity as part of its broader strategy to strengthen its metabolic disease portfolio.
A JW Pharmaceutical spokesperson said the company aims to confirm the drug’s weight-loss efficacy and tolerability in Korean patients and accelerate development of a new obesity treatment option combining clinical benefits with greater dosing convenience.
