NCT05687071已完成3 期
A Multicenter, Open-label, Uncontrolled, Long-term Trial to Assess the Safety and Efficacy of ETC-1002 in Patients With Hyper-LDL Cholesterolemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
A Multicenter, Open-label Study to assess the safety and efficacy of ETC-1002 at 180 mg administered for 52 weeks in patients with hyper-LDL cholesterolemia
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 who have difficulty in treatment with statins as defined below [Inadequate response to statins] Patients with hyper-LDL cholesterolemia who are currently taking or have previously taken statins[and other lipid-modifying therapies(LMTs) if needed] and cannot achieve the lipid management goals of LDL-C [Difficulty in treatment with statins] 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, or of those patients who have a history of statin administration and who are judged to have concerns of safety problems associated with the administration or dose increase of statins 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
- •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)
结局指标
主要结局
Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs)
时间窗: From baseline to week 52
Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52
时间窗: Baseline, week52
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100.
次要结局
- Percent Change in Non-HDL Cholesterol From Baseline to Week 52(Baseline, week52)
- Percent Change in Total Cholesterol From Baseline to Week 52(Baseline, week52)
- Percent Change in Apolipoprotein B From Baseline to Week 52(Baseline, week52)
- Percent Change in High Sensitivity C Reactive Protein From Baseline to Week 52(Baseline, week52)
- Percent Change in Hemoglobin A1c From Baseline to Week 52(Baseline, week52)
- Proportion of Subjects Whose LDL-C Value Achieved the Lipid Management Goals Based on Risk Assessment at Week 52(Baseline, week52)
研究者
研究点 (1)
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