NCT04709536已完成3 期
A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of IBI306 in Patients With Hypercholesterolemia in China (CREDIT-4)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- 1. Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at weeks 12
研究概览
简要总结
This study is designed for multi-center, double-blind, randomized, placebo-controlled phase III trial to evaluate the safety and tolerability of subcutaneous injection of IBI306 in hypercholesterolemia patients.
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
- Triple (Participant, 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
Experimental
IBI306 administered subcutaneously (SC)
干预措施: IBI306 (Drug)
Placebo
Placebo Comparator
administered subcutaneously (SC)
干预措施: Placebo (Drug)
结局指标
主要结局
1. Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at weeks 12
时间窗: Baseline to week12
次要结局
- The percent of subjects with LDL-C<70mg/dL(1.8 mmol/L)(Baseline to week24)
- The percent of subjects with LDL-C reduction no less than 50% from baseline(Baseline to week24)
- The percent change in Lp(a),ApoB, non-HDL-c, ApoB/ApoA1 from baseline(Baseline to week24)
研究者
研究点 (1)
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