NCT04720534已完成2 期
A Double-Blind, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of ARO-APOC3 in Adults With Severe Hypertriglyceridemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 229
- 试验地点
- 74
- 主要终点
- Percent Change From Baseline at Week 24 in Fasting Triglycerides (TG)
研究概览
简要总结
The purpose of AROAPOC3-2001 is to evaluate the efficacy and safety of ARO-APOC3 in participants with severe hypertriglyceridemia. Participants will receive 2 subcutaneous injections of ARO-APOC3.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Based on medical history, evidence of triglycerides (TG) ≥ 500 mg/dL and ≤ 4000 mg/dL at Screening
- •Fasting TG ≥ 500 mg/dL at Screening
- •Willing to follow diet counseling per Investigator judgment based on local standard of care
- •Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception
- •Willing to provide written informed consent and to comply with study requirements
排除标准
- •Active pancreatitis within 12 weeks prior to first dose
- •Any planned bariatric surgery or similar procedures to induce weight loss from consent to end of study
- •Acute coronary syndrome event within 24 weeks of first dose
- •Major surgery within 12 weeks of first dose
- •Planned coronary intervention (e.g., stent placement or heart bypass) or any non-cardiac major surgical procedure throughout the study
- •Uncontrolled hypertension
- •Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B (HBV), seropositive for Hepatitis C (HCV)
- •Uncontrolled hypothyroidism or hyperthyroidism
- •Hemorrhagic stroke within 24 weeks of first dose
- •Malignancy within the last 2 years prior to date of consent requiring systemic treatment (some exceptions apply)
- •Note: additional inclusion/exclusion criteria may apply per protocol
研究组 & 干预措施
Placebo, Day 1 and Week 12
Experimental
Participants received a total of 2 placebo SC injections on Day 1 and Week 12 for a total of 2 injections.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline at Week 24 in Fasting Triglycerides (TG)
时间窗: Baseline, Week 24
次要结局
- Percent Change From Baseline Over Time Through Week 48 in ApoC-III(Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET))
- Percent Change From Baseline at Week 24 in Fasting Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)(Baseline, Week 24)
- Percent Change From Baseline Over Time Through Week 48 in Fasting Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)(Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET))
- Percent Change From Baseline at Week 24 in Fasting High-Density Lipoprotein Cholesterol (HDL-C)(Baseline, Week 24)
- Percent Change From Baseline Over Time Through Week 48 in Fasting HDL-C(Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET))
- Percent Change From Baseline Over Time Through Week 48 in Fasting TG(Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET))
- Percent Change From Baseline at Week 24 in Apolipoprotein (Apo)C-III(Baseline, Week 24)
- Percent Change From Baseline at Week 24 in Fasting Total Apolipoprotein B (ApoB)(Baseline, Week 24)
- Percent Change From Baseline Over Time Through Week 48 in Fasting Total ApoB(Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET))
- Percent Change From Baseline at Week 24 in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C)(Baseline, Week 24)
- Percent Change From Baseline Over Time Through Week 48 in Fasting LDL-C(Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET))
- Change From Baseline in Plasma Concentrations of ARO-APOC3 Over TimeThrough Week 12(Day 1: pre-dose, 15 minutes, 1, 3, 6, 24 hours post-dose; Week 12: pre-dose, 15 minutes, 1, 3, 6, 24 hours post-dose)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(From first dose of study drug up to Week 48)
研究者
研究点 (74)
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