A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Clinical Study Comparing the Efficacy and Safety of Semaglutide Injection and WEGOVY® in Chinese Obese Patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- The percentage change in body weight from baseline to week 44
研究概览
简要总结
This is a 48-week randomized, open-label, parallel-controlled biosimilar comparison study comparing the efficacy, safety and immunogenicity of the investigational drug and WEGOVY® in patients with obesity. Eligible participants will be screened and randomized to the experimental group and the active comparator group at a ratio of 1:1 , semaglutide injection or WEGOVY® injection will be given once weekly for 44 weeks, following by a safety follow up of 4 weeks. All participants received a lifestyle intervention that involved counselling on diet and physical activity.
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
盲法说明
Statistician, data manager and medical monitor are masked to the randomized allocation.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged ≥18 years and ≤75 years at the time of signing informed consent；
- •BMI ≥28 kg/m2；
- •A self-reported change in body weight no more than 5% within 90 days before screening.
排除标准
- •History of type 1 and type 2 diabetes;
- •Previous or planned (during the trial period) obesity treatment with surgery or a weight-loss device;
- •History or presence of chronic or acute pancreatitis;
- •Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma;
- •A history or presence of suspected depression or other mental disorders;
- •Patient Health Questionnaire-9 score of ≥15 at screening
- •Uncontrolled hypertension, any of the following: myocardial infarction, stroke, hospitalisation for unstable angina, or transient ischaemic attack within the past 6 months prior to screening;
- •History of malignant neoplasms within the past 5 years prior to screening;
研究组 & 干预措施
HDM1702
干预措施: HDM1702 (Drug)
WEGOVY®
干预措施: Wegovy ® (Drug)
结局指标
主要结局
The percentage change in body weight from baseline to week 44
时间窗: week 44
次要结局
- ADA and NAb(week 44)
- The proportion of participants reaching a body weight loss of at least 5%, 10% and 15% at week 44(week 44)
- Change in waist circumference, body weight and BMI at week 44(week 44)
- Change in blood pressure and lipids at week 44(week 44)
- Adverse events(week 44)