NCT06723652已完成3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia
Beijing Suncadia Pharmaceuticals Co., Ltd1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2025年2月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Percent change in calculated LDL-C from baseline to week 12
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by SHR-1918 in patients with homozygous familial hypercholesterolemia (HoFH).
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of functional HoFH by either genetic or clinical criteria as defined in the protocol
- •LDL-C ≥2.6mmol/L at the screening visit
- •Body weight ≥40 kg
- •Receiving stable lipid-lowering therapy for at least 28 days before enrollment.
排除标准
- •Treatment with an ANGPTL3 inhibitor within 24 weeks prior before screening
- •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 12
时间窗: week 12
次要结局
- Change in calculated LDL-C from baseline to week 12(week 12)
- Percent change and changer in calculated LDL-C from baseline to week 24(week 24)
研究者
研究点 (1)
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