Life sciences · Phase 3 Trial
ClinicalTrials.gov · September 25, 2026
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Phase 3 Trial.
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Registry record from ClinicalTrials.gov (NCT06738979). This is a study registration, not published results. Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Recruitment status: COMPLETED. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 408 participants (ACTUAL). Conditions: Obesity. Interventions: DRUG: TQF3510 (Semaglutide Injection); DRUG: Wegovy®. Primary outcome measures: Percentage (%) of body weight loss , Baseline to week 44. Brief summary: 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.