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

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ID
NCT06738979
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • TQF3510 (Semaglutide Injection) — DRUG
    Semaglutide injection is a long-acting Glucagon-like peptide-1 (GLP-1) receptor agonist.
  • Wegovy® — DRUG
    Active Comparator

Study Details

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.

Key Dates

Start date
Mar 31, 2025
Status verified
Nov 2024
Primary completion
Jul 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
408 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TQF3510
    TQF3510: The drug treatment cycle was 44 weeks, including a dose escalation period of 16w and a stable dose period of 28w.
  • Active Comparator: Wegovy®
    Wegovy® : The drug treatment cycle consisted of a dose escalation period of 16w and a stable dose period of 28w.

Primary Outcome Measure

Percentage (%) of body weight loss [ Time Frame: Baseline to week 44 ]

Central Contacts

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