2022-501420-20-00招募中3 期
ISIS 678354-CS6 A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients with Severe Hypertriglyceridemia
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 248
- 试验地点
- 80
- 主要终点
- Percent Change from Baseline in Fasting TG Compared to Placebo [Time Frame: Baseline and Month 6]
研究概览
简要总结
To evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (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 both the Run-in period and the Qualification Period
- •Participants 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.
- •Participants must be willing to comply with diet and lifestyle
排除标准
- •Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening
- •Alanine aminotransferase or aspartate aminotransferase > 3.0 × upper
- •Total bilirubin > 1.5 ULN unless due to Gilbert’s syndrome
- •Estimated GFR < 30 mL/min/1.73 m^2
结局指标
主要结局
Percent Change from Baseline in Fasting TG Compared to Placebo [Time Frame: Baseline and Month 6]
Percent Change from Baseline in Fasting TG Compared to Placebo [Time Frame: Baseline and Month 6]
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 (80)
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