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Once-Monthly GLP-1 RA | Gan & Lee Pharmaceuticals Initiates Phase 3 Clinical Study (GRADUAL-3) of the First Chinese Once-Monthly GLP-1 RA for Weight Management
Previously, Gan & Lee has conducted two phase 3 clinical studies (GRADUAL-1 and GRADUAL-2) of bofanglutide injection for weight management in adults with obesity or overweight. In GRADUAL-2 study, bofanglutide injection is the first GLP-1 RA globally to be evaluated in a head-to-head, parallel-group comparison with semaglutide 2.4 mg (Wegovy ) in Chinese adults with obesity or overweight, with or without type 2 diabetes. These studies are designed to comprehensively assess and confirm the efficacy and safety of bofanglutide injection in patients with obesity or overweight, as well as its overall impact on metabolic parameters and cardiovascular risk factors.
The GRADUAL clinical development program of bofanglutide injection is designed to comprehensively evaluate its efficacy and safety in adults with overweight or obesity. Three large-scale phase 3 clinical studies are currently ongoing in China , with a planned total enrollment of more than 1,000 participants.
Bofanglutide injection (research code: GZR18) is a novel GLP-1 RA developed by Gan & Lee Pharmaceuticals. Its clinical development currently focuses on two indications: obesity/overweight and type 2 diabetes. Bofanglutide injection has demonstrated outstanding weight-loss and glucose-lowering effects in clinical studies, while also providing comprehensive metabolic benefits. The overall safety and tolerability profile of bofanglutide is consistent with that of marketed GLP-1 RAs. Currently, the global development of bofanglutide has advanced to the phase 3 stage.
Forward-looking statements are based on our expectations and assumptions as of the date of the statements. Actual results may differ materially from those expressed in these forward-looking statements due to a variety of factors, and we can give no assurance that such results will be achieved in the future. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
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