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

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completed without a posted recruiting period Primary completion date changed from estimate of Jul 2026 to Mar 7, 2026 · Study completion date changed from estimate of Aug 2026 to May 26, 2026 · Start date changed from estimate of Mar 2025 to Mar 20, 2025 · 2 more Show 5 more changesShow less
    • Primary completion date changed from estimate of Jul 2026 to Mar 7, 2026
    • Study completion date changed from estimate of Aug 2026 to May 26, 2026
    • Start date changed from estimate of Mar 2025 to Mar 20, 2025
    • Eligibility criteria expanded, about 16 words
    • Site details revised at 66 of 66 sites
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06738979
Lead Sponsor Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions Obesity
Enrollment 408 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov