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.
Jacobio Pharma partners with Oceanpine Capital to focus on core oncology pipeline
Johnson & Johnson to separate its Orthopaedics business as standalone DePuy Synthes
Ascletis selects once-monthly SQ GLP-1R/GIPR dual peptide agonist, ASC35, for clinical development
Autonomix Medical secures new US patent to expand precision nerve-targeted therapies
Merck completes acquisition of Verona Pharma to expand cardio-pulmonary portfolio
Amgen offers Repatha through AmgenNow direct-to-patient programme
MedHub-AI's AutocathFFR receives national reimbursement approval in Japan
Early, Evidence-Led Cardiovascular Care Strengthened in High-Risk MENA Regions
Corstasis and U.S. Heart and Vascular partner to advance heart failure care with ENBUMYST
Eli Lilly and Company's orforglipron outperforms oral semaglutide in Phase 3 ACHIEVE-3 trial
Merck reports positive Phase 3 results for oral PCSK9 inhibitor enlicitide
Abbott's Navitor TAVI system granted CE Mark for expanded indication