NCT05683340已完成3 期
A Placebo-controlled, Randomized, Multicenter, Double-blind, Parallel-group Trial to Confirm the Superiority of ETC-1002 in Patients With Hyper-LDL Cholesterolemia
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Percent Change in LDL-C From Baseline to Week 12
研究概览
简要总结
The purpose of this study is to confirm the superiority of ETC-1002 after 12 weeks of administration at 180 mg/day to placebo in patients with hyper-LDL cholesterolemia who have inadequate control of low-density lipoprotein cholesterol (LDL C).
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with inadequate response to statins or statin intolerance as defined below [Inadequate response to statins] Patients with hyper-LDL cholesterolemia who have been taking statins[and other lipid-modifying therapies(LMTs) if needed] and cannot achieve the lipid management goals of LDL-C [Statin intolerance] Patients with hyper-LDL cholesterolemia for whom safety problems have occurred while taking at least one type of statin, and who experienced resolution of the problems after discontinuation or dose reduction, and who cannot achieve the lipid management goals of LDL-C. Patients must be on the lowest or under the dosage of the approved dose of statin and/or on stable LMT(s).
- •Patients with fasting TG levels of <400 mg/dL at screening
- •Other protocol specific inclusion criteria may apply
排除标准
- •Females who are pregnant or breast-feeding or who have a positive pregnancy test (urine) result at screening or baseline visits
- •Patients with homozygous familial hypercholesterolemia (HoFH)
- •Patients who currently have or who have had within the past 3 months prior to screening any cardiovascular diseases, or those who have developed any cardiovascular diseases during the screening or before baseline visit
- •Uncontrolled hypertension, defined as sitting systolic blood pressure after resting 5 minutes of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg at screening
- •Patients with uncontrolled and serious hematologic or coagulation disorders or with hemoglobin of <10.0 g/dL at screening
- •Patients with uncontrolled diabetes with HbA1c of ≥9% at screening
- •Patients with uncontrolled hypothyroidism with thyroid-stimulating hormone (TSH) of >1.5 × ULN at screening
- •Patients with liver disease or dysfunction, including:
- •Positive serology for hepatitis B surface antigen (HBsAg) or a positive hepatitis C virus (HCV) antibody test at screening
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of ≥3 × ULN or total bilirubin of ≥2 × ULN at screening
- •Patients with creatine kinase (CK) of >3 × ULN at screening
- •Patients with a history or current renal dysfunction, nephritic syndrome, or nephritis, and with estimated glomerular filtration rate (eGFR) of ≤30 mL/min/1.73 m2 at screening
- •Other protocol specific exclusion criteria may apply
研究组 & 干预措施
ETC-1002 180mg
Experimental
干预措施: 180mg of ETC-1002(bempedoic acid) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change in LDL-C From Baseline to Week 12
时间窗: Baseline, week12
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 Week -1 and Day 1.
次要结局
- Percent Change in Non-HDL Cholesterol From Baseline to Week 12(Baseline, week12)
- Percent Change in Total Cholesterol From Baseline to Week 12(Baseline, week12)
- Percent Change in Apolipoprotein B From Baseline to Week 12(Baseline, week12)
- Percent Change in Hemoglobin A1c From Baseline to Week 12(Baseline, week12)
- Percent Change in High Sensitivity C Reactive Protein From Baseline to Week 12(Baseline, week12)
- Proportion of Subjects Whose LDL-C Value Achieved the Lipid Management Goals Based on Risk Assessment at Week 12(Baseline, week12)
研究者
研究点 (1)
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