A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Safety, Efficacy and Pharmacodynamics of CAT-2003 Alone and In Combination With A Statin in Patients With Hyperlipidemia (PATHWAYS I)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 主要终点
- Absolute and percent change from baseline in plasma triglycerides in patients with hypertriglyceridemia
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of different doses of CAT-2003 in patients with hyperlipidemia when CAT-2003 is taken for 4 weeks. The study will evaluate effects of CAT-2003 on (1) fasting triglycerides and non-HDL-C in patients with moderate hypertriglyceridemia and (2) fasting LDL-C levels in combination with a statin in patients with hypercholesterolemia who are on a statin.
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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 69 years at Screening
- •Hypertriglyceridemia (TG ≥ 200 mg/dL and < 500 mg/dL and non-HDL-C ≥ 100 mg/dL and < 220 mg/dL) OR
- •Hypercholesterolemia (LDL-C ≥ 100 mg/dL and < 190 mg/dL and TG value < 200 mg/dL) plus a stable dose of statin 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
- •Any condition that may predispose the patient to secondary hyperlipidemia, such as uncontrolled hypothyroidism
- •Any statin at the highest approved dose
- •Non-statin lipid-altering drugs other than cholesterol absorption inhibitors.
- •Active peptic ulcer disease or a history of muscle disease or myopathy
研究组 & 干预措施
CAT-2003 or Placebo Dose 3
Daily for 28 days in patients with moderate hypertriglyceridemia
干预措施: CAT-2003 (Drug)
CAT-2003 or Placebo Dose 1
Daily for 28 days in patients with moderate hypertriglyceridemia
干预措施: CAT-2003 (Drug)
CAT-2003 or Placebo Dose 1
Daily for 28 days in patients with moderate hypertriglyceridemia
干预措施: Placebo (Drug)
CAT-2003 or Placebo Dose 2
Daily for 28 days in patients with moderate hypertriglyceridemia
干预措施: CAT-2003 (Drug)
CAT-2003 or Placebo Dose 2
Daily for 28 days in patients with moderate hypertriglyceridemia
干预措施: Placebo (Drug)
CAT-2003 or Placebo Dose 3
Daily for 28 days in patients with moderate hypertriglyceridemia
干预措施: Placebo (Drug)
CAT-2003 or Placebo Dose 4
Daily for 28 days in patients with hypercholesterolemia who are on a statin
干预措施: CAT-2003 (Drug)
CAT-2003 or Placebo Dose 4
Daily for 28 days in patients with hypercholesterolemia who are on a statin
干预措施: Placebo (Drug)
CAT-2003 or Placebo Dose 4
Daily for 28 days in patients with hypercholesterolemia who are on a statin
干预措施: Statin (Drug)
结局指标
主要结局
Absolute and percent change from baseline in plasma triglycerides in patients with hypertriglyceridemia
时间窗: 4 weeks
Absolute and percent change from baseline in plasma low density lipoprotein-cholesterol in patients with hypercholesterolemia
时间窗: 4 weeks
次要结局
- Absolute and percent change from baseline in plasma non-high-density lipoprotein cholesterol(4 weeks)
- Pharmacodynamic effects of CAT-2003 on other lipid biomarkers in patients with hyperlipidemia(4 weeks)
- Frequency of adverse events(4 weeks)