2022-503022-13-00已完成3 期
ISIS 678354-CS9: A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) in Patients with Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), or with Severe Hypertriglyceridemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 577
- 试验地点
- 88
- 主要终点
- Percent change in fasting TG from Baseline at Week 25 compared to placebo.
研究概览
简要总结
To evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Participants must fall into 1 of the following groups (a or b): a. Hypertriglyceridemia with fasting TG ≥ 200 mg/dL (2.26 mmol/L) and < 500 mg/dL (5.65 mmol/L) b. Severe hypertriglyceridemia with fasting TG ≥ 500 mg/dL (5.65 mmol/L)
- •Clinical diagnosis of atherosclerotic cardiovascular disease (ASCVD) or
- •At increased risk for ASCVD
- •Participants should be on standard of care (SOC) lipid-lowering medications per local guidelines. Lipid-lowering medications should be optimized and stabilized for at least 4 weeks prior to Screening to minimize changes in these medications during the study.
排除标准
- •Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening
- •Alanine aminotransferase or aspartate aminotransferase > 3.0 × upper limit of normal
- •Total bilirubin > upper limit of normal unless due to Gilbert's syndrome
- •Estimated GFR < 30 mL/min/1.73 m2
结局指标
主要结局
Percent change in fasting TG from Baseline at Week 25 compared to placebo.
Percent change in fasting TG from Baseline at Week 25 compared to placebo.
次要结局
- Percent change in fasting TG from Baseline at Week 53 compared to placebo
- Proportion of patients who achieve fasting TG < 150 mg/dL (1. 69 mmol/L) at Week 25 and proportion of patients who achieve fasting TG < 150 mg/dL at Week 53 compared to placebo
- Percent change in fasting apoC-III, VLDL-C, remnant cholesterol, non-HDL-C, HDL-C, apoB, and LDL-C from Baseline at Week 25 and at Week 53 compared to placebo
- Safety and tolerability assessments include: adverse events (AEs), vital signs and weight, physical examinations, clinical laboratory tests, electrocardiogram (ECG), and use of concomitant medications. Safety and tolerability results in patients receiving olezarsen will be compared with those receiving placebo.
研究者
Global Regulatory Affairs
Scientific
Ionis Pharmaceuticals Inc.
研究点 (88)
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