A Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of ETC-1002 in Subjects With Hypercholesterolemia and Either Normal or Elevated Triglycerides.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 177
- 主要终点
- Percent Change From Baseline to Week 12 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C)
研究概览
简要总结
This Phase 2 proof-of-concept study will assess the lipid regulating efficacy and safety of ETC-1002 in subjects with hypercholesterolemia and either normal or elevated triglycerides.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of written informed consent prior to any study-specific procedure
- •Fasting LDL-C between 130 and 220 mg/dL following wash-out of all lipid regulating medications and supplements
- •Fasting triglyceride <400 mg/dL following wash-out of all lipid regulating medications and supplements
- •BMI between 18 and 35 mg/kg2
排除标准
- •Clinically significant cardiovascular disease, diabetes or uncontrolled hypertension
- •Females of child bearing potential (i.e., females who are not surgically sterile or post-menopausal)
研究组 & 干预措施
Placebo (Group 4)
Subjects with hypercholesterolemia and normal triglycerides
干预措施: Placebo (Drug)
ETC-1002 120 mg (Group 1)
Subjects with hypercholesterolemia and normal triglycerides
干预措施: ETC-1002 (Drug)
ETC-1002 80 mg (Group 2)
Subjects with hypercholesterolemia and normal triglycerides
干预措施: ETC-1002 (Drug)
ETC-1002 40 mg (Group 3)
Subjects with hypercholesterolemia and normal triglycerides
干预措施: ETC-1002 (Drug)
ETC-1002 120 mg (Group 5)
Subjects with hypercholesterolemia and elevated triglycerides
干预措施: ETC-1002 (Drug)
ETC-1002 80 mg (Group 6)
Subjects with hypercholesterolemia and elevated triglycerides
干预措施: ETC-1002 (Drug)
ETC-1002 40 mg (Group 7)
Subjects with hypercholesterolemia and elevated triglycerides
干预措施: ETC-1002 (Drug)
Placebo (Group 8)
Subjects with hypercholesterolemia and elevated triglycerides
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline to Week 12 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C)
时间窗: Baseline; 12 weeks
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Weeks -1 and 0. Least square (LS) mean percent change from Baseline to Week 12 was based on an analysis of covariance (ANCOVA) model with effects of treatment and triglyceride (TG) stratum and Baseline value as a covariate. Missing LDL-C values at Week 12 were imputed using the last observation carried forward (LOCF) procedure (only post-Baseline values were carried forward).
Percent Change From Baseline to Week 12 in LDL-C by Triglyceride (TG) Stratum
时间窗: Baseline; 12 weeks
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Weeks -1 and 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and center and Baseline value as a covariate. Missing LDL-C values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward).
次要结局
- Percent Change From Baseline to Week 12 in Free Fatty Acids (FFA)(Baseline; 12 weeks)
- Percent Change From Baseline to Week 12 in High-Sensitivity C-Reactive Protein (hsCRP)(Baseline; 12 weeks)
- Percent Change From Baseline to Week 12 in Total LDL Particles(Baseline; 12 weeks)
- Percent Change From Baseline to Week 12 in High-Density Lipoprotein-Cholesterol (HDL-C)(Baseline; 12 weeks)
- Percent Change From Baseline to Week 12 in Non-HDL-C(Baseline; 12 weeks)
- Percent Change From Baseline to Week 12 in Total Cholesterol (TC)(Baseline; 12 weeks)
- Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB)(Baseline; 12 weeks)
- Percent Change From Baseline to Week 12 in Apolipoprotein AI (ApoAI)(Baseline; 12 weeks)
- Percent Change From Baseline to Week 12 in TG(Baseline; 12 weeks)
- Percent Change From Baseline to Week 12 in Total HDL Particles(Baseline; 12 weeks)
- Number of Participants With Clinically Important Changes From Baseline in Vital Sign Values(Baseline; up to 12 weeks)
- Percent Change From Baseline to Week 12 in Lipoprotein (a)(Baseline; 12 weeks)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(up to 12 weeks)
- Number of Participants With Clinically Important Changes From Baseline in Electrocardiogram Values(Baseline; up to 12 weeks)
- Number of Participants With Clinically Significant Physical Examination Findings(up to 12 weeks)
- Number of Participants With the Indicated Abnormal Laboratory Parameter Values at Week 12(Week 12)