A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of IBI362 in Chinese Overweight and Obese Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 328
- 试验地点
- 1
- 主要终点
- Percent Change from Baseline in Body Weight
研究概览
简要总结
This is a multicenter, double-blind, randomized, placebo-controlled study conducted in overweight or obese subjects. This study is divided into the first stage and the second stage. The participant enrollment and data analysis in the two stage are independent and do not influence each other.
In the first stage of this study, about 240 subjects will be enrolled. Qualified subjects will receive placebo in a 2-week introduction period, after that, they will be randomized to IBI362 low dose, IBI362 moderate dose, IBI362 high dose groups, in every group, subjects will be randomized to IBI362 and placebo groups at a ratio of 3:1. Random stratification is performed based on BMI < 28.0 kg/㎡ and BMI≥28.0 kg/㎡. The subjects received drug administration once weekly. The entire trial covers a 3-week screening period, a 2-week placebo introduction period, a-24 week double-blind treatment period, and a 12-week drug discontinuation follow-up period. During the entire research period, the subjects shall maintain diet and exercise control.
The second stage is IBI362 extra high dose study, about 80 subjects will be enrolled. Qualified participants will receive placebo in a 2-week introduction period, after that, they will be randomized to IBI362 extra high dose and placebo groups at a ratio of 3:1. The subjects received drug administration once weekly. The entire trial covers a 3-week screening period, a 2-week placebo introduction period, a 24-week double-blind treatment period, a 24-week extended treatment period, and a 12-week drug discontinuation follow-up period. The 24-week extended treatment period is optional. During the entire research period, the subjects shall maintain diet and exercise control.
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
- Double (Participant, Investigator)
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
- •The first stage: Body mass Index (BMI) ≥28 kilograms per square meter (kg/m²), or ≥24 kg/m² with at least one of the following comorbidities: hyperphagia, pre-diabetes, hypertension, dyslipidemia, fatty liver disease, weight-bearing joint pain, obesity-induced dyspnea or obstructive sleep apnea syndrome; The second stage: Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²)
- •The weight change of the subjects before and after the introduction period was less than 5.0%
排除标准
- •Diabetes mellitus
- •Weight change > 5.0% after diet and exercise control for at least 12 weeks before screening
- •Have used or are currently using weight loss drugs within 3 months before screening
- •History of pancreatitis
- •Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- •History of moderate to severe depression，or have a history of serious mental illness
- •Any lifetime history of a suicide attempt
研究组 & 干预措施
placebo
placebo administered subcutaneously (SC) once a week.
干预措施: placebo (Other)
IBI362 high dose
high dose IBI362 administered subcutaneously (SC) once a week.
干预措施: IBI362 (Drug)
IBI362 low dose
Low dose IBI362 administered subcutaneously (SC) once a week.
干预措施: IBI362 (Drug)
IBI362 moderate dose
moderate dose IBI362 administered subcutaneously (SC) once a week.
干预措施: IBI362 (Drug)
IBI362 extra high dose
extra high dose IBI362 administered subcutaneously (SC) once a week.
干预措施: IBI362 (Drug)
结局指标
主要结局
Percent Change from Baseline in Body Weight
时间窗: Baseline ,week 24
Percent Change from Baseline in Body Weight
次要结局
- Change from Baseline in systolic blood pressure(Baseline, Week 24)
- Change from Baseline in diastolic blood pressure(Baseline, Week 24)
- Percentage of Participants who Achieve ≥5% Body Weight Reduction(Baseline, Week 24)
- Percentage of Participants who Achieve ≥10% Body Weight Reduction(Baseline, Week 24)
- Absolute change from Baseline in body weight(Baseline, Week 24)
- Change from Baseline in Waist Circumference(Baseline, Week 24)
- Change from Baseline in BMI(Baseline, Week 24)
- Change from Baseline in HbA1c(Baseline, Week 24)
- Change from Baseline in fasting plasma glucose(Baseline, Week 24)
- Change from Baseline in total cholesterol(Baseline, Week 24)
- Change from Baseline in low-density lipoprotein cholesterol(Baseline, Week 24)
- Change from Baseline in high-density lipoprotein cholesterol(Baseline, Week 24)
- Change from Baseline in triglyceride(Baseline, Week 24)
- Change from Baseline in serum uric acid(Baseline, Week 12, Week 24)
- Change from Baseline in IWQoL-Lite-CT questionnaire scores(Baseline, Week 24)