Gan & Lee commences Phase III clinical trial of GLP-1 RA in China

Gan & Lee Pharmaceuticals has commenced the Phase III GRADUAL-3 clinical trial to assess the once-monthly administration of the glucagon-like peptide-1 receptor agonist (GLP-1 RA) bofanglutide (GZR18) in adults with overweight or obesity in China. The trial aims to evaluate the safety and effectiveness of the injection for weight management, focusing on sustaining weight loss and promoting long-term treatment adherence.

In GRADUAL-3, bofanglutide will be administered subcutaneously every four weeks over a 24-week period. The primary outcomes being measured are the percentage change in body weight and absolute change from baseline at week 24.

Professor Linong Ji of Peking University People's Hospital is serving as the principal investigator for the study. This trial follows Gan & Lees prior Phase III studies, GRADUAL-1 and GRADUAL-2, which examined bofanglutide for weight management in adults with overweight or obesity.

GRADUAL-3 is designed to determine whether a monthly dosing schedule can enhance long-term adherence and help participants maintain weight loss, thanks to reduced injection frequency. The GRADUAL programme, encompassing these three Phase III trials, targets over 1,000 participants across China to evaluate the injections effectiveness for weight reduction.

GRADUAL-1 was a 52-week study involving approximately 630 adults who did not achieve sufficient weight loss through diet and exercise alone. GRADUAL-2, also lasting 52 weeks, included around 471 adults and compared bofanglutide with Wegovy in participants with or without type 2 diabetes.

The GRADUAL-3 trial focuses on sustaining weight loss through once-monthly dosing. Bofanglutides safety and tolerability profile remains consistent with other GLP-1 receptor agonists, and its global clinical development is currently in Phase III.

Author: Sophia Brooks