A Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg QD When Added to Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)-Inhibitor Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Month 2
研究概览
简要总结
The purpose of this study is to determine if bempedoic acid (ETC-1002) 180mg added to PCSK9 inhibitor (evolocumab) therapy is effective and safe in patients with elevated LDL cholesterol.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years or legal age of majority depending on regional law
- •Fasting, calculated LDL-C at screening ≥160 mg/dL and following PCSK9i therapy ≥70 mg/dL
- •Men and nonpregnant, nonlactating women
排除标准
- •Heterozygous (HeFH) or Homozygous (HoFH) Familial Hypercholesterolemia
- •Total fasting TG ≥500 mg/dL
- •Renal dysfunction or a glomerulonephropathy; eGFR <30 mL/min/1.73 m2
- •Known cardiovascular disease (CVD), peripheral arterial disease (PAD), or cerebrovascular disease (CD)
- •History of type 1 or type 2 diabetes
- •Uncontrolled hypertension
- •Uncontrolled hypothyroidism
- •Liver disease or dysfunction
- •Gastrointestinal conditions or procedures (including Lap-Band® or gastric bypass)
- •History of hematologic or coagulation disorders
- •History of malignancy (except non-metastatic basal or squamous cell carcinoma of the skin and cervical carcinoma in situ)
- •Unexplained creatine kinase (CK) >3 × ULN
- •Use of a cholesterylester transfer protein (CETP) inhibitor in the last 12 months prior to screening, such as: anacetrapib, dalcetrapib, or evacetrapib
- •Pregnant or breast feeding, or planning to become pregnant during treatment and/ or within 30 days after the end of treatment
研究组 & 干预措施
bempedoic acid
Bempedoic acid 180mg tablet taken orally, once daily plus evolocumab (Repatha) 420mg injection once monthly
干预措施: bempedoic acid 180mg (Drug)
bempedoic acid
Bempedoic acid 180mg tablet taken orally, once daily plus evolocumab (Repatha) 420mg injection once monthly
干预措施: evolocumab (Drug)
placebo
Matching placebo tablet taken orally, once daily plus evolocumab (Repatha) 420mg injection once monthly
干预措施: placebo (Other)
placebo
Matching placebo tablet taken orally, once daily plus evolocumab (Repatha) 420mg injection once monthly
干预措施: evolocumab (Drug)
结局指标
主要结局
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Month 2
时间窗: Baseline; Month 2
Percent change from Baseline is calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value ) x 100. Baseline is defined as the average of the last two non-missing values within Month -1 (Screening Visit 4) and Day 1 (Treatment Visit 1) values (including unscheduled assessments). If only one value was available, then that single value was used at Baseline. Percent change from Baseline was analyzed using analysis of covariance (ANCOVA), with treatment group as a factor and Baseline as a covariate. Missing data were imputed using last observation carried forward (LOCF) (only post-Baseline values were carried forward).
次要结局
- Absolute Change From Baseline in LDL-C at Month 1 and Month 2(Baseline; Month 1 and Month 2)
- Percent Change From Baseline in LDL-C at Month 1(Baseline; Month 1)
- Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE)(up to Month 2 (until 30 days after last dose))
- Percent Change From Baseline in Lipid Profile Parameters at Month 1 and Month 2(Baseline; Month 1 and Month 2)
- Number of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >3x the Upper Limit of Normal (ULN) at Month 1 and Month 2(Month 1 and Month 2)
- Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Month 1 and Month 2(Baseline; Month 1 and Month 2)