A Phase 2 Pilot Study to Assess the Safety and Efficacy of CAT-2003 in Patients With Severe Hypertriglyceridemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 主要终点
- Percent change from baseline in fasting triglycerides in patients with severe hypertriglyceridemia
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of multiple doses of CAT-2003 in patients with severe hypertriglyceridemia either naive or refractory to current therapy. The study will evaluate effects of CAT-2003 on fasting and postprandial total triglycerides and chylomicron triglyceride levels in patients with severe hypertriglyceridemia.
This is a single-blind study. All patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 74 years at Screening
- •Severe Hypertriglyceridemia (TG ≥ 500 mg/dL). If on lipid lowering therapy including statins, fibrates, and/or omega-3 fatty acids, stable dose for at least 4 weeks prior to Screening
- •Body mass index (BMI) ≤ 45 kg/m2
排除标准
- •History of any major cardiovascular event within 6 months of Screening
- •Type I diabetes mellitus or use of insulin
- •History of pancreatitis
研究组 & 干预措施
CAT-2003 or Placebo
All patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day treatment period.
干预措施: CAT-2003 (Drug)
CAT-2003 or Placebo
All patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day treatment period.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change from baseline in fasting triglycerides in patients with severe hypertriglyceridemia
时间窗: 4 weeks
次要结局
- Frequency of adverse events(4 weeks)
- Absolute and percent change from baseline on postprandial total and chylomicron triglyceride levels(4 weeks)