A Clinical Study Comparing Semaglutide Injection and Wegovy® for Weight Management in Obese Subjects

This is a multicenter, randomized, open, parallel, positive-controlled clinical study to evaluate the efficacy and safety of Semaglutide injection (TQF3510) developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. in obese subjects (BMI≥28 kg/m2). Equivalence tests were performed for the percentage (%) of weight loss at 44w relative to baseline at the primary endpoint. A meta-analysis was performed based on multiple registration studies of the original drug Wegovy® (semaglutide), and the final equivalence threshold was determined (-4.16%, 4.16%). It was assumed that the sample size ratio of the experimental group and the control group was 1:1, the overall difference between the experimental group and the control group was 0, the standard deviation of the reference original drug was 11%, and the degree of assurance (1-β) was 85%. Double unilateral t test was adopted, and double unilateral α=0.025. The sample size was 326 cases by the Power Analysis \& Sample Size (PASS) 2019 Software. Considering the 20% shedding rate, 408 patients were enrolled in this study, 204 in each group.

Inclusion Criteria: * Age 18-70 years old, gender is not limited; * Body mass index (BMI) ≥ 28 kg/m2; * Self-report at least one unsuccessful diet and weight loss history; * Patients must give informed consent to this study before the trial and sign the informed consent voluntarily. Exclusion Criteria: * Pregnant or lactating women or men or women of childbearing age who had a pregnancy plan during the study period (including a spouse), or who refused to take the contraceptive measures specified in the programme during the study period; * Have a history of diabetes of any type; * Patients who had used any hypoglycemic drugs within 90 days before screening; * Personal or first-degree relatives have a personal or family history of thyroid C-cell tumor or multiple endocrine tumor syndrome type 2; * Use of any drugs for weight management within 90 days prior to screening; * Previous or planned weight loss related treatment through surgery or other weight loss means during the study period; * Have a history of major depression or serious mental illness; * Mental Health Scale (PHQ-9) score ≥ 15 during screening; * History of acute pancreatitis within 180 days prior to screening; * Have a history of chronic pancreatitis or pancreatic surgery; * Laboratory tests during screening meet any of the following criteria: 1. Alanine aminotransferase (ALT)\> 2.5× upper limit of normal (ULN), aspartate aminotransferase (AST)\>2.5 ULN; 2. Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2; 3. calcitonin ≥ 50 ng/L (pg/mL); 4. Triglyceride (TG) ≥500 mg/dl (5.7mmol/L); 5. Thyroid stimulating hormone (TSH) \>6 mIU/L or \