2024-510696-38-00已完成3 期
ISIS 678354-CS5: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 678354 Administered Subcutaneously to Patients with Severe Hypertriglyceridemia.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 368
- 试验地点
- 83
- 主要终点
- Percent Change from Baseline in Fasting TG at 6 Months (Average of Weeks 25 and 27) Compared to Placebo.
研究概览
简要总结
To evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting TG from Baseline.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Fasting TG ≥ 500 mg/dL (5.65 mmol/L) at Screening and Qualification.
- •Patients must be on lipid-lowering therapy that should adhere to standard of care (SOC) 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.
- •18 Years and older (Adult, Older Adult).
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.
结局指标
主要结局
Percent Change from Baseline in Fasting TG at 6 Months (Average of Weeks 25 and 27) Compared to Placebo.
Percent Change from Baseline in Fasting TG at 6 Months (Average of Weeks 25 and 27) Compared to Placebo.
次要结局
- Percent Change from Baseline in Fasting TG Compared to Placebo [Time Frame: Baseline and Month 12]
- Percent Change from Baseline in Fasting Apolipoprotein C-III (ApoC-III), Remnant Cholesterol and Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) Compared to Placebo (Time Frame: Baseline, Month 6 and 12]
- Proportion of Patients who Achieve Fasting TG <500 mg/dL (5.65 mmol/L) Compared to Placebo [Time Frame: Month 12]
- Proportion of Patients Who Achieve Fasting TG < 880 mg/dL (10 mmol/L) Compared to Placebo in the Subgroup of Patients with Baseline TG ≥ 880 mg/dL [Time Frame: Month 12]
- Adjudicated Acute Pancreatitis Event Rate During the Treatment Period Compared to Placebo [Time Frame: Week 1 through Week 53]
- Absolute Change in Hepatic Fat Fraction (HFF) Between Olezarsen Treatment Group and Placebo
研究者
Global Regulatory Affairs
Scientific
Ionis Pharmaceuticals Inc.
研究点 (83)
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