NCT04270760已完成2 期
A Double-blind, Randomized, Placebo-controlled Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of Olpasiran (AMG 890) in Subjects With Elevated Lipoprotein(a)
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
- Amgen
- 入组人数
- 281
- 试验地点
- 36
- 主要终点
- Percentage Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 36
研究概览
简要总结
Evaluate the effect of olpasiran administered subcutaneously (SC) compared with placebo, on percent change from baseline in lipoprotein(a) (Lp[a]).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80 years
- •Lipoprotein (a) > 150 nmol/L
- •Evidence of atherosclerotic cardiovascular disease
排除标准
- •Severe renal dysfunction
- •History or clinical evidence of hepatic dysfunction
- •Malignancy within the last 5 years
- •Currently receiving, or less than 3 months at Day 1 since receiving > 200 mg/day Niacin
研究组 & 干预措施
Arm 1 Olpasiran Dose 1
Active Comparator
干预措施: Olpasiran (Drug)
Arm 2 Olpasiran Dose 2
Active Comparator
干预措施: Olpasiran (Drug)
Arm 3 Olpasiran Dose 3
Active Comparator
干预措施: Olpasiran (Drug)
Arm 4 Olpasiran Dose 4
Active Comparator
干预措施: Olpasiran (Drug)
Arm 5 Placebo Dose 5
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 36
时间窗: Baseline and Week 36
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.
次要结局
- Percentage Change From Baseline in Lp(a) at Week 48(Baseline and Week 48)
- Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 36 and Week 48(Baseline; Week 36 and Week 48)
- Percentage Change From Baseline in Apolipoprotein (B) (ApoB) at Week 36 and Week 48(Baseline; Week 36 and Week 48)
- Mean Serum Olpasiran Concentrations at Day 1, Week 24 and Week 48(Pre-dose and 1, 3, 6-12, and 24-72 hours post-dose on Day 1 and Week 24; Week 48)
研究者
研究点 (36)
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