A Randomized, Double-Blind, Parallel Group, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of CVI-LM001 in Patients With Hypercholesterolemia
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)
研究概览
简要总结
The purpose of this study is to determine if CVI-LM001 is effective and safe versus placebo in drug-naive subjects with elevated LDL cholesterol. There will be 4 groups receiving 100mg, 200mg, 300 mg and placebo treatment for 12 weeks respectively.
详细描述
This study is a phase II study in subjects with elevated LDL cholesterol. As designed, the study will start with a 4-week, single-blind, placebo run-in period based on diet and exercise interventions for screening eligible subjects. After run-in, eligibility is confirmed with required laboratory tests at Day -1 prior to randomization. The eligible subjects are randomly assigned to CVI-LM001 100 mg, 200 mg, 300mg QD group or placebo QD group with ratio 1:1:1:1 to receive a 12-week double-blind treatment. After 12-week treatment, all investigational compound and placebo should be discontinued, followed by 4 week for safety evaluation.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-70 years, inclusive
- •Men and nonpregnant, nonlactating women
- •Hypercholesterolemic subjects with LDL-C level between 3.36mmol/L~4.88mmol/L at screening, inclusive
排除标准
- •Fasting TG ≥3.99 mmol/L before randomization
- •History of significant cardiovascular , renal, pulmonary and liver diseases
- •History of diabetes
- •ALT or AST>1.5XULN at screening
研究组 & 干预措施
100 mg
干预措施: 100 mg (Drug)
200 mg
干预措施: 200 mg (Drug)
300 mg
干预措施: 300 mg (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)
时间窗: 12 weeks
The percent change of LDL-C from baseline by comparing CVI-LM001 arms with placebo after 12 weeks of treatment
From Baseline to Week 12 in Number of Participants with Treatment-Emergent Adverse Events
时间窗: 12 weeks
Comparison treatment-emergent adverse events of LM001 arms with placebo arm after 12 weeks of treatment
次要结局
- Percent Change From Baseline to Week 12 in Total Cholesterol (TC)(12 weeks)
- Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB)(12 weeks)
- Percent Change From Baseline to Week 12 in Triglyceride (TG)(12 weeks)
- Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)(12 weeks)
- Percent Change From Baseline to Week 12 in Lipoprotein（ a）(Lp(a))(12 weeks)
- Percent Change From Baseline to Week 12 in Proprotein Convertase Subtilisin/Kexin Type 9(PCSK9)(12 weeks)
- Percent Change From Baseline to Week 12 in Apolipoprotein A1 (Apo A1)(12 weeks)
- Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)(12 weeks)