[Translation] A multicenter, randomized, open, positive-controlled Phase III clinical trial comparing the efficacy and safety of semaglutide injection from United Biopharma and the original drug in the treatment of obese patients
本研究使用珠海联邦生物医药有限公司(简称“联邦生物”)研制的司美格鲁肽注射液和诺和诺德研制生产的司美格鲁肽注射液对肥胖患者进行为期44周的治疗,比较两组治疗前后体重、腰围等较基线的变化;同时比较两组胃肠道事件、低血糖事件的发生率和其他相关安全性指标。主要目的是评估联邦生物研制的司美格鲁肽注射液治疗肥胖患者的有效性及安全性。
[Translation] This study used semaglutide injection developed by Zhuhai United Biopharmaceutical Co., Ltd. (hereinafter referred to as "United Bio") and semaglutide injection developed and produced by Novo Nordisk to treat obese patients for 44 weeks, and compared the changes in body weight, waist circumference, etc. from baseline before and after treatment between the two groups; at the same time, the incidence of gastrointestinal events, hypoglycemia events and other related safety indicators between the two groups were compared. The main purpose is to evaluate the efficacy and safety of semaglutide injection developed by United Bio in the treatment of obese patients.