2024-511331-96-00招募中2 期
A Phase 2 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of ARO-APOC3 in Adults with Dyslipidemia
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 178
- 试验地点
- 18
- 主要终点
- Subject incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
To evaluate the safety and efficacy of long-term treatment with ARO-APOC3 in adults with mixed dyslipidemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 主要目的
- Single arm open label extension of the parent studies AROAPOC3-2001 and AROAPOC3-2002
- 盲法
- None
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
- •Adults ≥18 years of age who are nonpregnant, nonlactating, and do not plan to become pregnant during the study
- •Able and willing to provide written informed consent prior to the performance of any study specific procedures
- •Completed the 48-week study treatment period in the parent study
排除标准
- •Subject was permanently discontinued from ARO-APOC3 in the parent study due to: a. Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT), or b. Elevated HbA1c. (hemoglobin A1c).
- •Any new condition or worsening of existing condition (eg, renal, hematologic, gastrointestinal, endocrine, cardiovascular, pulmonary, immunologic, psychiatric) or any other situation that, in the Investigator’s judgment, would make the subject unsuitable for enrollment, could interfere with the subject participating in or completing the study, would make it difficult to comply with protocol requirements, or put the subject at additional safety risk
- •Unwilling to limit alcohol consumption to within moderate limits for the duration of the study, as follows: not more than 14 units per week (1 unit approximately corresponds to 80 mL of wine, 200 mL of beer, or 25 mL of 40% alcohol)
结局指标
主要结局
Subject incidence of treatment-emergent adverse events (TEAEs)
Subject incidence of treatment-emergent adverse events (TEAEs)
次要结局
- Change and percent change from baseline over time in fasting TG (triglyceride)
- Change and percent change from baseline over time in apolipoprotein (Apo)C-III
- Change and percent change from baseline over time in fasting non-high-density lipoprotein cholesterol (non-HDL-C)
- Change and percent change from baseline over time in fasting HDL-C
- Change and percent change from baseline over time in fasting total apolipoprotein B (ApoB)
- Change and percent change from baseline over time in fasting LDL-C (low-density lipoprotein cholesterol) using ultracentrifugation
研究者
Armine Balian
Scientific
Arrowhead Pharmaceuticals Inc.
研究点 (18)
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