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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 408
- 试验地点
- 65
- 主要终点
- Percentage (%) of body weight loss
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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:
- •Alanine aminotransferase (ALT)> 2.5× upper limit of normal (ULN), aspartate aminotransferase (AST)>2.5 ULN;
- •Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2;
- •calcitonin ≥ 50 ng/L (pg/mL);
- •Triglyceride (TG) ≥500 mg/dl (5.7mmol/L);
- •Thyroid stimulating hormone (TSH) >6 mIU/L or <0.4 mIU/L.
- •When virological tests at the time of screening show any of the following:
- •Hepatitis C virus (HCV) antibody positive, and HCV virus titer detection value exceeds the upper limit of normal value;
- •HBsAg positive and Hepatitis B virus (HBV) DNA test value exceeds the upper limit of normal value;
- •HIV positive;
- •Active syphilis: the screening period of treponema pallidum antibody positive and non-Treponema pallidum serum test (RPR or TRUST) positive;
- •Uncontrolled or poorly treated hypertension;
- •Clinically significant cardiovascular and cerebrovascular disease in the 6 months prior to screening;
- •People who are allergic to Semaglutide injection or any component of Wegovy®, or to other GLP-1 receptor agonists, or who have a pre-existing allergic disorder;
- •Participated in any other clinical trial within 3 months prior to screening;
- •The subject is unable to comply with the treatment plan and diet and exercise plan established by the investigator;
- •There are secondary causes affecting body weight;
- •There is hypothyroidism at the time of screening that is not controlled with stable drug dosages;
- •Have a history of major surgery within 6 months prior to screening;
- •A history of drug abuse or alcohol dependence within the 6 months prior to screening;
- •History of malignant tumor within 5 years before screening;
- •Patients with other diseases that the researchers assessed would affect the safety of the subjects, affect the efficacy evaluation or compliance, or other conditions that the researchers considered unsuitable for enrollment.
研究组 & 干预措施
Wegovy®
Wegovy® : The drug treatment cycle consisted of a dose escalation period of 16w and a stable dose period of 28w.
干预措施: Wegovy® (Drug)
TQF3510
TQF3510: The drug treatment cycle was 44 weeks, including a dose escalation period of 16w and a stable dose period of 28w.
干预措施: TQF3510 (Semaglutide Injection) (Drug)
结局指标
主要结局
Percentage (%) of body weight loss
时间窗: Baseline to week 44
Percentage (%) of body weight loss relative to baseline in both groups at week 44.
次要结局
- Proportion of subjects with a body weight loss of ≥5%(Baseline to week 44)
- Waist circumference change from baseline(Baseline to week 44)