Gan & Lee Pharmaceuticals has initiated the Phase III GRADUAL-3 clinical trial of once-monthly glucagon-like peptide-1 receptor agonist (GLP-1 RA) bofanglutide (GZR18) injection in adults with obesity or are overweight in China.
The study will evaluate the injection’s safety and efficacy for weight management in China, with an aim to maintain weight loss and support long-term adherence.
GRADUAL-3 involves administering bofanglutide subcutaneously every four weeks for 24 weeks.
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The primary endpoints of the trial are percentage change and change in body weight from baseline at week 24.
Professor Linong Ji from Peking University People’s Hospital is serving as the leading principal investigator.
Gan & Lee previously conducted two Phase III clinical studies, GRADUAL-1 and GRADUAL-2, to evaluate bofanglutide for weight management in adults with overweight or obesity.
The GRADUAL-3 trial specifically explores whether a once-monthly regimen can improve long-term adherence and help maintain achieved weight loss due to reduced injection frequency.
The GRADUAL clinical development programme comprising these three Phase III studies is assessing bofanglutide injection for weight loss and targets over 1,000 subjects in China.
GRADUAL-1 is a 52-week study in around 630 adults with overweight or obesity who failed to achieve adequate weight loss with diet and exercise.
With the same duration, GRADUAL-2 involves nearly 471 adult participants, comparing bofanglutide to Wegovy in those with or without type two diabetes.
The latest trial, GRADUAL-3, is focused on the maintenance of weight loss through once-monthly dosing.
The overall tolerability and safety profile of bofanglutide is said to be consistent with existing GLP-1 RAs. Its global development is currently at the Phase III stage.
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