NCT06109831已完成2 期
An Efficacy, Safety Study to Evaluate Multiple Subcutaneous SHR-1918 in Combination With Lipid-Lowering Drugs for the Stable Treatment of Hyperlipidemic Patients With Poor Lipid Control-A Multicenter, Randomized, Double-Blind, Placebo-Parallel-Controlled, Phase II Clinical Study
Beijing Suncadia Pharmaceuticals Co., Ltd1 个研究点 分布在 1 个国家目标入组 335 人开始时间: 2023年11月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 335
- 试验地点
- 1
- 主要终点
- Percent change in calculated LDL-C from baseline to week 16
研究概览
简要总结
This is a Multicenter, Randomized, Double-Blind, Placebo-Parallel-Controlled, Phase II Clinical Stud to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by SHR-1918 in patients with Hyperlipidemic.
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
- •Regularly taking any moderate-intensity or higher dose* of statin stabilization therapy for ≥4 weeks at screening:
- •ASCVD risk is ultra-high risk Fasting LDL-C ≥ 1.4 mmol/L;
- •ASCVD risk very high risk Fasting LDL-C ≥1.8 mmol/L;
- •ASCVD risk is intermediate or high risk Fasting LDL-C ≥ 2.6 mmol/L.
- •Any other condition that is not met at screening Regularly taking any moderate intensity and higher dose* statin stabilization therapy for ≥4 weeks;
- •a) Fasting LDL-C ≥ 2.6 mmol/L.
- •Fasting triglycerides ≤ 5.6 mmol/L.
排除标准
- •Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (HbA1c > 8.5%).
- •eGFR <30ml/min/1.73m2 at the screening visit.
- •CK >5times ULN at the screening visit.
研究组 & 干预措施
SHR-1918
Experimental
干预措施: SHR-1918 (Drug)
SHR-1918 placebo
Placebo Comparator
干预措施: SHR-1918 placebo (Drug)
结局指标
主要结局
Percent change in calculated LDL-C from baseline to week 16
时间窗: from baseline to week 16
次要结局
- Change in calculated LDL-C from baseline to week 16(from baseline to week 16)
研究者
研究点 (1)
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