Trial of ARI-3037MO to Reduce Triglyceride Levels in Adults With Severe (≥500 mg/dl) Hypertriglyceridemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- Change in Triglyceride levels
研究概览
简要总结
This study is to evaluate the efficacy and safety of ARI-3037MO 3g BID compared to placebo in reducing triglyceride (TG) levels of subjects with severe (≥500 mg/dL and <2,000 mg/dL) hypertriglyceridemia. Eligible patients will enter a 4- to 6-week lead-in period (6-week washout for subjects on non-statin lipid-lowering therapy [subjects may remain on statins during this period], 4 weeks for patients on statins only or not receiving any type of lipid-lowering therapy), followed by qualifying fasting TG measurements at visits 2 and 3, at least 7 days apart. If the baseline TG value is > 500 mg/dL and < 2,000 mg/dL, the qualified subjects will be randomized at visit 4 and enter the double-blind, 12-week efficacy and safety assessment phase. End-of-study lipid levels will be assessed on visits 6 and 7 (weeks 11 and 12 average). A final closeout and safety assessment visit will be done 14 weeks post randomization
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ARI-3037MO
ARI-3037MO 3g bid orally for 12 weeks
干预措施: ARI-3037MO (Drug)
Placebo
Matching placebo 3g bid orally for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Triglyceride levels
时间窗: 12 weeks
次要结局
- Change in LDL cholesterol(12 weeks)
- Change in HDL cholesterol(12 weeks)
