A Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of ETC-1002 Versus Placebo in Patients With Hypercholesterolemia Receiving Ongoing Statin Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 133
- 主要终点
- Percent change from baseline in calculated low density lipoprotein-cholesterol (LDL-C)
研究概览
简要总结
The purpose of this research study is to see how ETC-1002 is tolerated in the body and how ETC-1002 affects the levels of LDL-C (bad cholesterol) in patients receiving ongoing statin therapy.
详细描述
Approximately 132 hypercholesterolemic patients already taking statin therapy to treat elevated LDL-C will be randomized in a ratio of 1:1:1 to receive either ETC-1002 (120 mg or 180 mg dose), or placebo for 12 weeks in addition to ongoing statin therapy. This study will explore the safety and efficacy of ETC-1002 when given to patients receiving statin therapy.
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
- •Fasting, calculated mean LDL-C ≥130 mg/dL and ≤220 mg/dL
- •Fasting mean TG level ≤400 mg/dL
- •Stable statin therapy for at least 3 months prior to screening: atorvastatin (10 or 20 mg daily), simvastatin (5, 10 or 20 mg daily), rosuvastatin (5 or 10 mg daily), or pravastatin (10, 20 or 40 mg daily)
排除标准
- •Clinically significant cardiovascular disease within 12 months of screening
- •Current muscle-related symptoms that may be due to ongoing statin therapy or a history of certain lab abnormalities that occurred during statin therapy and resolved when statin therapy was discontinued
- •Type 1 diabetes or uncontrolled type 2 diabetes
- •Use of metformin or thiazolidinediones (TZD) within 4 weeks of screening
- •History of chronic musculoskeletal symptoms such as fibromyalgia
- •Uncontrolled hypothyroidism
- •Liver disease or dysfunction
- •Renal dysfunction or nephritic syndrome
- •Gastrointestinal conditions or procedures or surgeries
- •Hematologic or coagulation disorders or low hemoglobin levels
- •HIV or AIDS
- •History of malignancy
- •History of drug or alcohol abuse within 2 years
- •Use of experimental or investigational drugs within 30 days of screening
- •Use of ETC-1002 in a previous clinical study
研究组 & 干预措施
ETC-1002 120 mg/day
Orally, once daily in morning as capsules
干预措施: ETC-1002 (Drug)
ETC-1002 120 mg/day
Orally, once daily in morning as capsules
干预措施: Statin Therapy (Drug)
ETC-1002 180 mg/day
Orally, once daily in morning as capsules
干预措施: ETC-1002 (Drug)
ETC-1002 180 mg/day
Orally, once daily in morning as capsules
干预措施: Statin Therapy (Drug)
Placebo
Orally, once daily in morning
干预措施: Placebo (Drug)
Placebo
Orally, once daily in morning
干预措施: Statin Therapy (Drug)
结局指标
主要结局
Percent change from baseline in calculated low density lipoprotein-cholesterol (LDL-C)
时间窗: 12 weeks
次要结局
- Percent change in total cholesterol (TC)(12 weeks)
- Percent change in non-high-density lipoprotein cholesterol (non-HDL-C)(12 weeks)
- Percent change in lipoprotein particle number(12 weeks)
- Percent change in apolipoprotein B (ApoB)(12 weeks)
- Percent change in high-sensitivity C-reactive protein (hsCRP)(12 weeks)
- Percent change in triglycerides (TG)(12 weeks)
- Safety using adverse event reports; clinical laboratory results(12 weeks)
- Safety using adverse event reports; vital signs(12 weeks)
- Pharmacokinetic plasma trough concentrations of ETC-1002 and metabolite 15228(12 weeks)