A Multicenter, Randomized, Double-Blind, Placebo-Controlled 28- Day Phase II Proof of Concept Study to Evaluate the Efficacy and Safety of NST-1024 400 mg BID Versus Placebo in Statin-Naïve or Statin-Stable Hypertriglyceridemic Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 31
- 主要终点
- Evaluate the efficacy of NST-1024 by percentage change in TG
研究概览
简要总结
This is a Phase IIa,multicentre proof of concept study consisting of 2 study periods to study Treatment with NST-1024 as an adjunct to diet to reduce triglyceride (TG) levels in subjects with TG levels of ≥500 mg/dL and ≤2000 mg/dL; determined by percentage change in TG from baseline after 28 days of treatment.
The two periods consist of:
- A 3-week screening period that includes a TG qualifying period, and
- A 28-days, double-blind, randomized, parallel group, placebo-controlled treatment period.
Subjects will return to the study site for a follow-up visit 2 weeks after the last dose.
Approximately 50 subjects will be randomized at approximately 15-30 centres in USA.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 79 Years（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
Matched Placebo
干预措施: Placebo (Other)
NST-1024
NST-1024 400 mg BID
干预措施: NST-1024 (Drug)
结局指标
主要结局
Evaluate the efficacy of NST-1024 by percentage change in TG
时间窗: 4 weeks
Evaluate the efficacy of NST-1024 400 mg BID by assessment of the percentage change in TG from baseline after 28 days of treatment
次要结局
- Safety Assessments(~ 8 weeks)
- Change in insulin resistance.(4 weeks)
- Change in lipoprotein associated phospholipase A2(4 weeks)
- Percent Change in Lipoprotein a(4 weeks)
- Percent Change in remnant-like particle cholesterol (RLP-C)(4 weeks)
- Change in hsCRP(4 weeks)
- Percent change in Apolipoprotein B and Apolipoprotein C3(4 weeks)
- Changes in fasting plasma glucose, fasting plasma insulin, and HbA1c(4 weeks)
- Percent Change in Cholesterol Values(4 weeks)