NCT03011450已完成3 期
A Phase 3, Multi-Center, Placebo-Controlled, Randomized, Double--Blind, 12-Week Study With a 40-Week, Active-Controlled, Open-Label Extension to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting Triglyceride Levels ≥500 mg/dL and <2000 mg/dL and Mild or Moderate Renal Impairment
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
- 471
- 试验地点
- 236
- 主要终点
- Percent Change in Fasting TG From Baseline to Week 12
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients With Fasting High Triglyceride Levels ≥500 mg/dL and <2000 mg/dL and Mild or Moderate Renal Impairment.
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
- •Able to understand and willing to comply with all study requirements and procedures throughout the duration of the study and give written informed consent;
- •Aged ≥18 years;
- •Patients receiving moderate- or high-intensity statin therapy must meet one of the following criteria¹ unless they have any exceptional conditions (see inclusion criterion 4):
- •Aged ≥21 years with clinical atherosclerotic cardiovascular disease (ASCVD) (history of acute coronary syndrome or myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack [TIA] presumed to be of atherosclerotic origin, or peripheral arterial disease or revascularization), on a high-intensity statin (or moderate-intensity statin if not a candidate for high-intensity statin due to safety concerns);
- •Aged ≥21 years with a history of LDL-C ≥190 mg/dL, which is not due to secondary modifiable causes, on a high-intensity statin (or moderate-intensity statin if not a candidate for high-intensity statin due to safety concerns);
- •Aged 40 to 75 years, inclusive, without clinical ASCVD but with diabetes and a history of LDL-C of 70 to 189 mg/dL, inclusive, on a moderate- or high-intensity statin; or
- •Aged 40 to 75 years, inclusive, without clinical ASCVD or diabetes, with a history of LDL-C of 70 to 189 mg/dL, inclusive, with estimated 10-year risk for ASCVD of ≥7.5% by the Pooled Cohort Equation on a moderate- or high-intensity statin;
- •Patients currently on a low-intensity statin or not on a statin, must meet one of the following criteria;
- •Patient does not meet any criteria for moderate- or high-intensity statin therapy listed above (see inclusion criteria, 3.a. through 3.d.);
- •Patient does meet one or more criteria for moderate- or high-intensity statin therapy listed above (see inclusion criteria 3.a. through 3.d.); but the patient is not a candidate for moderate or high-intensity statin due to safety concerns, or due to partial or complete statin intolerance; or
- •Patient does meet one or more criteria for moderate- or high intensity statin therapy listed above (see inclusion criteria 3.b. through 3.d., except for 3.a.); but the patient is not a candidate for moderate or high intensity statin for primary prevention after considering individual risk evaluation (e.g. current LDL C ≤70mg/dL) and patient preference;
- •Fasting TG levels ≥500 mg/dL (5.65 mmol/L) and <2000 mg/dL (22.60 mmol/L) based on the mean of Visit 2 (Week -2) and Visit 3 (Week -1).
- •Mild to moderate renal impairment eGFR >= 30mL/min/1.73 and < 90 mL/min/1.73 at Visit 1
排除标准
- •Patients who will require lipid-altering treatments other than study drugs (K-877 or fenofibrate), statins, ezetimibe, or PCSK9 inhibitors during the course of the study. These include bile acid sequestrants, non-study fibrates, niacin (>100 mg/day), omega-3 fatty acids (>1000 mg/day), or any supplements used to alter lipid metabolism including, but not limited to, red rice yeast supplements, garlic supplements, soy isoflavone supplements, sterol/stanol products, or policosanols;
- •Body mass index (BMI) >45 kg/m2 at Visit 1 (Week -8 or Week -6);
- •Patients with type 1 diabetes mellitus;
- •Patients with newly diagnosed (within 3 months prior to Visit 2 [Week -2]) or poorly controlled type 2 diabetes mellitus (T2DM), defined as hemoglobin A1c >9.5% at Visit 1 (Week -8 or Week -6);
研究组 & 干预措施
12 Week Efficacy
Placebo Comparator
K-877 or placebo comparator for 12 weeks
干预措施: K-877 (Drug)
12 Week Efficacy
Placebo Comparator
K-877 or placebo comparator for 12 weeks
干预措施: Placebo (for K-877) (Drug)
40 week extension
Active Comparator
K-877 or fenofibrate comparator for 40 weeks
干预措施: K-877 (Drug)
40 week extension
Active Comparator
K-877 or fenofibrate comparator for 40 weeks
干预措施: Fenofibrate (Drug)
结局指标
主要结局
Percent Change in Fasting TG From Baseline to Week 12
时间窗: 12 Weeks
次要结局
- Percent Change From Baseline to Week 52 in Fasting TG(52 Weeks)
- Percent Change From Baseline to Week 52 in HDL-C(52 Weeks)
- Percent Change From Baseline to Week 12 in Apo A1(12 Weeks)
- Percent Change From Baseline to Week 52 in Apo A2(52 Weeks)
- Percent Change From Baseline to Week 52 in Apo B(52 Weeks)
- Percent Change From Baseline to Week 52 in Apo C2(52 Weeks)
- Percent Change From Baseline to Week 12 in Apo A2(12 Weeks)
- Percent Change From Baseline to Week 12 in Apo B(12 Weeks)
- Percent Change From Baseline to Week 12 in Apo C2(12 Weeks)
- Percent Change From Baseline to Week 12 in HDL-C(12 Weeks)
- Percent Change From Baseline to Week 12 in Non-HDL-C(12 Weeks)
- Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo B:Apo A1(52 Weeks)
- Percent Change From Baseline to Week 12 in Remnant Cholesterol(12 Weeks)
- Percent Change From Baseline to Week 12 in Total Cholesterol(12 Weeks)
- Percent Change From Baseline to Week 12 in LDL-C(12 Weeks)
- Percent Change From Baseline to Week 12 in Apo B48(12 Weeks)
- Percent Change From Baseline to Week 12 in Lipoprotein Fraction HDL Cholesterol (Total)(12 Weeks)
- Percent Change From Baseline to Week 12 in FFAs(12 Weeks)
- Percent Change From Baseline to Week 12 in Apo B100(12 Weeks)
- Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TG:HDL-C(12 Weeks)
- Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins I)(12 Weeks)
- Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIa)(12 Weeks)
- Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 2b)(12 Weeks)
- Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Particles-Large)(12 Weeks)
- Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particle Size)(12 Weeks)
- Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B(12 Weeks)
- Percent Change From Baseline to Week 52 in Remnant Cholesterol(52 Weeks)
- Percent Change From Baseline to Week 52 in Apo A1(52 Weeks)
- Percent Change From Baseline to Week 52 in Non-HDL-C(52 Weeks)
- Change From Baseline to Week 12 in FGF21(12 Weeks)
- Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Small)(12 Weeks)
- Percent Change From Baseline to Week 12 in Apo C3(12 Weeks)
- Change From Baseline to Week 12 in hsCRP(12 Weeks)
- Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVb)(12 Weeks)
- Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 3 and 2a)(12 Weeks)
- Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Medium)(12 Weeks)
- Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Large)(12 Weeks)
- Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Large)(12 Weeks)
- Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Triglyceride)(12 Weeks)
- Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2(12 Weeks)
- Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Intermediate)(12 Weeks)
- Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 2)(12 Weeks)
- Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVa)(12 Weeks)
- Percent Change From Baseline to Week 12 in Ion Mobility (Diameter of the Major LDL Particle (Å))(12 Weeks)
- Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles)(12 Weeks)
- Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Medium)(12 Weeks)
- Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TC:HDL-C(12 Weeks)
- Percent Change From Baseline to Week 12 in Apo E(12 Weeks)
- Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Large)(12 Weeks)
- Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Small)(12 Weeks)
- Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 1)(12 Weeks)
- Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIa)(12 Weeks)
- Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIb)(12 Weeks)
- Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIb)(12 Weeks)
- Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVc)(12 Weeks)
- Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Particles)(12 Weeks)
- Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Small)(12 Weeks)
- Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles)(12 Weeks)
- Change From Baseline to Week 12 in Lipoprotein Fraction (IDL Particles)(12 Weeks)
- Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Small)(12 Weeks)
- Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particle Size)(12 Weeks)
- Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particle Size)(12 Weeks)
- Percent Change From Baseline to Week 12 in Lipoprotein Fraction (Triglyceride)(12 Weeks)
- Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo B:Apo A1(12 Weeks)
- Percent Change From Baseline to Week 52 in TC(52 Weeks)
- Percent Change From Baseline to Week 52 in Ion Mobility (High Density Lipoproteins 2b)(52 Weeks)
- Percent Change From Baseline to Week 52 in Apo B100(52 Weeks)
- Percent Change From Baseline to Week 52 in Apo C3(52 Weeks)
- Change From Baseline to Week 52 in FGF21(52 Weeks)
- Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Large)(52 Weeks)
- Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 1)(52 Weeks)
- Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIa)(52 Weeks)
- Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIb)(52 Weeks)
- Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVb)(52 Weeks)
- Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Particles-Large)(52 Weeks)
- Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Small)(52 Weeks)
- Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles)(52 Weeks)
- Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particle Size)(52 Weeks)
- Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TG:HDL-C(52 Weeks)
- Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2(52 Weeks)
- Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C(12 Weeks)
- Percent Change From Baseline to Week 52 in FFAs(52 Weeks)
- Percent Change From Baseline to Week 52 in Apo B48(52 Weeks)
- Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIb)(52 Weeks)
- Percent Change From Baseline to Week 52 in LDL-C(52 Weeks)
- Percent Change From Baseline to Week 52 in Apo E(52 Weeks)
- Change From Baseline to Week 52 in hsCRP(52 Weeks)
- Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Intermediate)(52 Weeks)
- Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 2)(52 Weeks)
- Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIa)(52 Weeks)
- Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVa)(52 Weeks)
- Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVc)(52 Weeks)
- Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Small)(52 Weeks)
- Percent Change From Baseline to Week 52 in Ion Mobility (High Density Lipoproteins 3 and 2a)(52 Weeks)
- Percent Change From Baseline to Week 52 in Ion Mobility (Diameter of the Major LDL Particle (Å))(52 Weeks)
- Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins I)(52 Weeks)
- Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Particles)(52 Weeks)
- Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Medium)(52 Weeks)
- Change From Baseline to Week 52 in Lipoprotein Fraction (IDL Particles)(52 Weeks)
- Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Small)(52 Weeks)
- Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles)(52 Weeks)
- Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Large)(52 Weeks)
- Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Medium)(52 Weeks)
- Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particle Size)(52 Weeks)
- Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particle Size)(52 Weeks)
- Percent Change From Baseline to Week 52 in Lipoprotein Fraction (Triglyceride)(52 Weeks)
- Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Small)(52 Weeks)
- Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Large)(52 Weeks)
- Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Cholesterol)(52 Weeks)
- Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C(52 Weeks)
- Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B(52 Weeks)
- Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Triglyceride)(52 Weeks)
- Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TC:HDL-C(52 Weeks)
研究者
研究点 (236)
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