Chinese biopharmaceutical company Gan & Lee Pharmaceuticals Co., Ltd. (SHA: 603087) announced on Thursday that it has begun GRADUAL-3, its third large-scale phase 3 study of the GLP-1 receptor agonist bofanglutide (GZR18) in overweight adults and adults with obesity.
The 24-week study will assess the efficacy and safety of a once-monthly subcutaneous dose in maintaining weight loss, with primary endpoints focused on absolute and percentage changes in body weight.
GRADUAL-3 follows two earlier phase 3 trials, GRADUAL-1 and GRADUAL-2, which evaluated weight-loss outcomes in similar patient groups. GRADUAL-2 was the first global head-to-head phase 3 parallel-group comparison between bofanglutide and semaglutide 2.4 mg (Wegovy) in overweight or obese Chinese adults, with or without type 2 diabetes.
Across the GRADUAL programme, more than 1,000 participants in China are enrolled in three ongoing phase 3 trials examining weight-loss efficacy, metabolic effects and cardiovascular risk factors. The company said GRADUAL-3 is intended to determine whether a once-monthly regimen can improve long-term adherence and help prevent weight regain.
Bofanglutide, now in global phase 3 development, is being studied for obesity, overweight and type 2 diabetes and has shown weight-loss, glucose-lowering and broader metabolic benefits with a safety profile consistent with other marketed GLP-1 receptor agonists.
Gan & Lee Pharmaceuticals launches third phase 3 trial of once-monthly bofanglutide
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