NCT05413135已完成2 期
A Phase 2 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of ARO-APOC3 in Adults With Dyslipidemia
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
- 418
- 试验地点
- 120
- 主要终点
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
This is an open-label extension of the parent studies AROAPOC3-2001 and AROAPOC3-2002. Adult participants with dyslipidemia who completed the blinded 12-month period from either parent study and continued to meet eligibility criteria had the option to be enrolled into this study. Eligible enrolled participants initially received open-label ARO-APOC3 every three or six months at the assigned dose level of the parent study until a final dose of 25 mg was selected, at which point all participants transitioned to the selected dosing regimen of 25 mg every 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adults who are nonpregnant, nonlactating and do not plan to become pregnant during the study
- •Able and willing to provide written informed consent
- •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 elevated glycated hemoglobin (HbA1c), aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
- •Any new condition or worsening of existing condition or any other situation that 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
研究组 & 干预措施
ARO-APOC3
Experimental
1 dose of ARO-APOC3 by subcutaneous (sc) injection every 3 months
干预措施: ARO-APOC3 (Drug)
结局指标
主要结局
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
时间窗: Through 24 months
次要结局
- Percent Change from Baseline in Fasting HDL-C Over Time(Through 24 months)
- Change from Baseline in Fasting Triglycerides (TG) Over Time(Through 24 months)
- Change from Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time(Through 24 months)
- Percent Change from Baseline in Fasting Total ApoB Over Time(Through 24 months)
- Change from Baseline in Apolipoprotein (Apo) C-III Over Time(Through 24 months)
- Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time(Through 24 months)
- Percent Change from Baseline in Fasting TG Over Time(Through 24 months)
- Change from Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) Over Time(Through 24 months)
- Percent Change from Baseline in Fasting Non-HDL-C Over Time(Through 24 months)
- Percent Change from Baseline in ApoC-III Over Time(Through 24 months)
- Change from Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) Over Time Using Ultracentrifugation(Through 24 months)
- Percent Change from Baseline in Fasting LDL-C Over Time Using Ultracentrifugation(Through 24 months)
研究者
研究点 (120)
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