Safety and Efficacy of IBI306 in Chinese Non-familial Hypercholesterolemia Subjects at Very High or High Cardiovascular Risk: a Randomized, Double-blind and Placebo-controlled Phase III Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 804
- 试验地点
- 1
- 主要终点
- Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at week 48
研究概览
简要总结
IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol(LDL-C) uptake. This study is being done to investigate the effects of IBI306 in Chinese people with non-familial hypercholesterolemia with very high or high cardiovascular risk. This study will see if IBI306 will reduce low density lipoprotein cholesterol (LDL-C) in Chinese people who are taking a certain type of lipid-lowering medication (statins with or without ezetimibe) and whether it causes any side effects
详细描述
This is a phase 3, multicenter, double-blind, randomized, placebo-controlled study of IBI306 in Chinese non-familial hypercholesterolemia Subjects with very high or high cardiovascular risk. A total of around 600 subjects who meet admission criteria will be randomized and receive one of the two dose levels of IBI306 or matching placebo: 450mg Q4W, or 600mg Q6W. The double blind period for both groups will be 48 weeks. The study will last 52 weeks
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
IBI306 450mg SC Q4W
干预措施: IBI306 450mg SC Q4W (Drug)
Placebo SC Q4W
干预措施: Placebo SC Q4W (Drug)
IBI306 600mg SC Q6W
干预措施: IBI306 600mg SC Q6W (Drug)
Placebo SC Q6W
干预措施: Placebo SC Q6W (Other)
结局指标
主要结局
Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at week 48
时间窗: Week 48
次要结局
- The percent of subjects with LDL-C<70mg/dL(1.8 mmol/L)(Week 48)
- The percent of subjects with LDL-C reduction no less than 50% from baseline(Week 48)
- The percent change in Lp(a),ApoB, non-HDL-c, ApoB/ApoA1 from baseline(Week 48)