Gan & Lee Pharmaceuticals is now entering its third large-scale phase 3 clinical study, GRADUAL-3, of its glucagon-like peptide-1 receptor agonist (GLP-1 RA) bofanglutide injection in the adult population with overweight or obesity. This study will be covering bofanglutide injection administration once every four weeks, every month, to discover its capability to manage the improved long-standing adherence and potent weight loss.
The phase 3 study is engineered to assess the safety and efficacy of one-time monthly bofanglutide injection for body weight after a total of 24 weeks of consistent treatment. The Peking University People’s Hospital’s Professor Linong Ji is the former principal investigator for this study. The initial endpoints were the percentage and fluctuation impact from the first week in body weight to the last week.
Describing GRADUAL-3 from descending order after its GRADUAL1 and 2 studies, this third clinical study will discover the capability of once-monthly bofanglutide injection. By alleviating injection volume and delivering a comfort treatment regimen, the study might contribute to identifying the main challenges and long-standing treatment adherence linked with GLP-1 RA therapy, consisting of suboptimal durability and weight regain of the weight-loss efficacy to date.
The company had also organised the two-phase 3 clinical studies named ‘GRADUAL-1 and GRADUAL-2’ of bofanglutide injection for the adult population weight management with overweight or obesity. Under the GRADUAL-2 study, the bofanglutide injection marked as a first-ever GLP-1 RA worldwide to be examined in a parallel, differentiated and one-on-one comparison with semaglutide 2.4 mg, Wegovy® in the Chinese adult group with overweight or obesity, regardless of type 2 diabetes.
These studies are engineered to effectively evaluate and prove the safety and efficacy of bofanglutide injection, including its impact on cardiovascular risk factors and metabolic parameters.
The GRADUAL clinical development program chain of bofanglutide injection is engineered to sharply assess its safety and efficacy frequency in the adult population with obesity or overweight. The GRADUAL-1 study was led for 52 weeks in around 630 Chinese overweight adults who failed to achieve weight loss with exercise and diet. The GRADUAL-2 took 52 weeks, covering 471 Chinese overweight adults who hadn’t yet achieved weight loss despite exercise and diet, regardless of type 2 diabetes.
Whereas, now GRADUAL-3 took 24 weeks of study initiated to discover the safety and efficacy of once-monthly bofanglutide injection on managing the weight-loss impact.
Holding M.Pharm in Pharmaceutical Chemistry, Chandni crafts cutting-edge, research-driven healthcare news for Towards Healthcare, combining scientific depth with innovative storytelling to simplify complex topics for global readers.
