NCT07839936尚未招募2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of VERVE-102, a One-Time Dose Gene Editing Medicine, in Adults With or at High Risk for Atherosclerotic Cardiovascular Disease (ASCVD) Who Require Additional Low-Density Lipoprotein-Cholesterol (LDL-C) Lowering
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Percent Change from Baseline in LDL-C
研究概览
简要总结
The purpose of this study is to measure the change in bad cholesterol (LDL-C) with VERVE-102 compared to placebo in adults who have plaque buildup in their arteries or are at high risk of developing it.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established atherosclerotic cardiovascular disease (ASCVD) and/or at a high risk of ASCVD
排除标准
- •History of confirmed or suspected homozygous familial hypercholesterolemia (HoFH)
- •Chronic liver disease
- •Current treatment with PCSK9 inhibitor or prior treatment within specified timeframe
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will receive a single dose of placebo IV
干预措施: Placebo (Drug)
VERVE-102 Dose 1
Experimental
Participants will receive a single dose of VERVE-102 intravenously (IV)
干预措施: VERVE-102 (Drug)
VERVE-102 Dose 2
Experimental
Participants will receive a single dose of VERVE-102 IV
干预措施: VERVE-102 (Drug)
VERVE-102 Dose 3
Experimental
Participants will receive a single dose of VERVE-102 IV
干预措施: VERVE-102 (Drug)
结局指标
主要结局
Percent Change from Baseline in LDL-C
时间窗: Baseline, Day 90
次要结局
- Percent Change from Baseline in LDL-C(Baseline to End of Study (up to Day 365))
- Percent Change from Baseline in Circulating Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)(Baseline to End of Study (up to Day 365))
- Percent Change from Baseline Total Cholesterol(Baseline to End of Study (up to Day 365))
- Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C)(Baseline to End of Study (up to Day 365))
- Percent Change from Baseline in Apolipoprotein B(Baseline to End of Study (up to Day 365))
研究者
研究点 (1)
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