NCT07613294招募中3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of Lepodisiran to Investigate the Effect on Coronary Plaque in Adults With Elevated Lp(a) Who Have Established Atherosclerotic Cardiovascular Disease or Are at Risk for a First Cardiovascular Event
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 252
- 试验地点
- 58
- 主要终点
- Percent Change from Baseline in Noncalcified Plaque (NCP) Volume
研究概览
简要总结
Lipoprotein(a), also known as Lp(a), is a protein that carries cholesterol and proteins in your blood. People with high Lp(a) have a higher risk for heart disease. The main purpose of the study is to investigate how lepodisiran, compared to a placebo, affects the amount and type of plaque in the heart's vessels using an imaging technology known as Coronary Computed Tomography Angiography (CCTA) in adults who have high levels of Lp(a).
Participation will last about 120 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have an Lp(a) ≥175 nmol/L
- •Have established cardiovascular (CV) disease or are at risk for a first CV event
- •Have angiographic evidence of coronary artery disease on screening CCTA
- •If taking lipid-lowering medications, inclusive of statins or prescription strength niacin and PCSK9 inhibitors, these should be stable for 8 weeks
排除标准
- •Have had a major CV event less than 60 days before measurement of the Lp(a) level used for eligibility or uncontrolled high blood pressure at screening
- •Have moderate to severe renal dysfunction
- •Have severe heart failure
- •Have a history of coronary artery bypass graft surgery (CABG)
- •Have a planned coronary angiography, percutaneous coronary intervention (PCI), coronary artery bypass graft, or valvular intervention
- •Have had a procedure to remove lipoproteins from the blood or received therapy specifically targeting Lp(a)
- •Are unable to safely undergo CCTA due to medication intolerance, contrast allergies, or anatomical/technical factors
研究组 & 干预措施
Lepodisiran
Experimental
Participants will receive lepodisiran subcutaneously (SC)
干预措施: Lepodisiran (Drug)
Placebo
Placebo Comparator
Participants will receive placebo SC
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change from Baseline in Noncalcified Plaque (NCP) Volume
时间窗: Baseline, Week 104
次要结局
- Percent Change from Baseline in Mean Fat Attenuation Index (FAI) Score(Baseline, Week 104)
- Percent Change from Baseline in Lp(a) Level(Baseline through Week 104)
- Percentage of Participants Reporting Strongly Agree or Agree on the Subcutaneous Administration Assessment Questionnaire (SQAAQ) Version 3.0 Items(Week 26, Week 78)
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3819469(Predose through Week 52)
研究者
研究点 (58)
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