A Multicenter, Randomized, Open, Parallel Controlled Phase III Study Comparing the Efficacy and Safety of Semaglutide Injection and Wegovy® for Weight Management in Obese Subjects
Overview
- Phase
- Phase 3
- Intervention
- Wegovy®
- Conditions
- Obesity
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Enrollment
- 408
- Locations
- 65
- Primary Endpoint
- Percentage (%) of body weight loss
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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;
Arms & Interventions
Wegovy®
Wegovy® : The drug treatment cycle consisted of a dose escalation period of 16w and a stable dose period of 28w.
Intervention: Wegovy®
TQF3510
TQF3510: The drug treatment cycle was 44 weeks, including a dose escalation period of 16w and a stable dose period of 28w.
Intervention: TQF3510 (Semaglutide Injection)
Outcomes
Primary Outcomes
Percentage (%) of body weight loss
Time Frame: Baseline to week 44
Percentage (%) of body weight loss relative to baseline in both groups at week 44.
Secondary Outcomes
- Proportion of subjects with a body weight loss of ≥5%(Baseline to week 44)
- Waist circumference change from baseline(Baseline to week 44)