Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Normal Renal Function
Phase 3
Completed
- Conditions
- Severe Hypertriglyceridemia
- Interventions
- Registration Number
- NCT03001817
- Lead Sponsor
- Kowa Research Institute, Inc.
- Brief Summary
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 normal renal function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 551
Inclusion Criteria
-
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, criterion 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;
Exclusion Criteria
- 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);
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 40 Week Extension Placebo (for K-877) K-877 with placebo matching fenofibrate or fenofibrate with placebo matching K-877 for 40 weeks 12 Week Efficacy Placebo (for K-877) K-877 or placebo comparator twice daily for 12 weeks 40 Week Extension Placebo (for Fenofibrate) K-877 with placebo matching fenofibrate or fenofibrate with placebo matching K-877 for 40 weeks 40 Week Extension K-877 K-877 with placebo matching fenofibrate or fenofibrate with placebo matching K-877 for 40 weeks 12 Week Efficacy K-877 K-877 or placebo comparator twice daily for 12 weeks 40 Week Extension Fenofibrate K-877 with placebo matching fenofibrate or fenofibrate with placebo matching K-877 for 40 weeks
- Primary Outcome Measures
Name Time Method Percent Change of Fasting Triglyceride(TG) Levels From Baseline to Week 12 12 Weeks
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline to Week 52 in Fasting TG 52 Weeks Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins I 12 Weeks Percent Change From Baseline to Week 52 in FFAs 52 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 12 in LDL-C 12 Weeks Percent Change From Baseline to Week 12 in Apo A2 12 Weeks Percent Change From Baseline to Week 12 in Apo B100 12 Weeks Percent Change From Baseline to Week 12 in Apo C2 12 Weeks Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Small 12 Weeks Percent Change From Baseline to Week 12 in Remnant Cholesterol 12 Weeks Percent Change From Baseline to Week 12 in Apo B48 12 Weeks Percent Change From Baseline to Week 12 in Apo C3 12 Weeks Percent Change From Baseline to Week 12 in Apo E 12 Weeks Change From Baseline to Week 12 in Fibroblast Growth Factor 21 (FGF21) 12 Weeks Change From Baseline to Week 12 in hsCRP 12 Weeks Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Large 12 Weeks Percent Change From Baseline to Week 12 in Apo A1 12 Weeks Percent Change From Baseline to Week 12 in Total Cholesterol 12 Weeks Percent Change From Baseline to Week 12 in Free Fatty Acids (FFAs) 12 Weeks Percent Change From Baseline to Week 12 in Apo B 12 Weeks Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Intermediate 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 - Intermediate Density Lipoproteins 2 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 IIIa 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 Lipoprotein Fraction - VLDL & Chylomicron Particles 12 Weeks Two types of lipoprotein particles were analyzed together as one measurement without distinction.
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Particles-Large 12 Weeks Two types of lipoprotein particles were analyzed together as one measurement without distinction.
Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particles-Medium 12 Weeks Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles (Total) 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 52 in HDL-C 52 Weeks Percent Change From Baseline to Week 52 in Non-HDL-C 52 Weeks Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVc 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 B48 52 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 IIIb 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 Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction.
Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particles-Small 12 Weeks Percent Change From Baseline to Week 12 in Lipoprotein Fraction - Triglyceride (Total) 12 Weeks Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B 12 Weeks Percent Change From Baseline to Week 12 in Ion Mobility - High Density Lipoproteins 2b 12 Weeks Percent Change From Baseline to Week 12 in Ion Mobility - Major LDL Particle Measurement 12 Weeks Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles (Total) 12 Weeks Change From Baseline to Week 12 in Lipoprotein Fraction - Intermediate-density Lipoprotein (IDL) Particles 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 - LDL Particles-Small 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 - HDL Particles-Small 12 Weeks Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particle Size 12 Weeks Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Medium 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 Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C 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 Remnant Cholesterol 52 Weeks Percent Change From Baseline to Week 52 in Apo A1 52 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 - VLDL & Chylomicron Triglyceride 12 Weeks Two types of lipoprotein particles were analyzed together as one measurement without distinction.
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Cholesterol 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 52 in TC 52 Weeks Percent Change From Baseline to Week 52 in LDL-C 52 Weeks Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Total Cholesterol (TC):HDL-C 12 Weeks Percent Change From Baseline to Week 52 in Apo B100 52 Weeks Percent Change From Baseline to Week 52 in Apo C2 52 Weeks Percent Change From Baseline to Week 52 in Apo C3 52 Weeks Percent Change From Baseline to Week 52 in Apo E 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 - VLDL Cholesterol-Intermediate 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 I 52 Weeks Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIIa 52 Weeks Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Large 52 Weeks Change From Baseline to Week 52 in hsCRP 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 - 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 - High Density Lipoproteins 3 and 2a 52 Weeks Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction.
Percent Change From Baseline to Week 52 in Ion Mobility - Diameter of the Major LDL Particle 52 Weeks Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Particles 52 Weeks Two types of lipoprotein particles were analyzed together as one measurement without distinction.
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 - LDL 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 - VLDL & Chylomicron Triglyceride 52 Weeks Two types of lipoprotein particles were analyzed together as one measurement without distinction.
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TC:HDL-C 52 Weeks Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C 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 Ion Mobility - Low Density Lipoproteins IIIb 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 IVb 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 Lipoprotein Fraction - VLDL & Chylomicron Particles-Large 52 Weeks Two types of lipoprotein particles were analyzed together as one measurement without distinction.
Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particles-Medium 52 Weeks Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particles-Small 52 Weeks Change From Baseline to Week 52 in Lipoprotein Fraction - IDL Particles 52 Weeks Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles-Large 52 Weeks Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVc 52 Weeks Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles (Total) 52 Weeks Change From Baseline to Week 52 in Lipoprotein Fraction - LDL 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 - Triglyceride 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 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 52 in Lipoprotein Fraction - HDL Particles-Small 52 Weeks Percent 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 Lipid and Lipoprotein Ratios of Apo B:Apo A1 52 Weeks
Trial Locations
- Locations (220)
Central Research Associates, Inc.
🇺🇸Birmingham, Alabama, United States
Central Alabama Research
🇺🇸Birmingham, Alabama, United States
Cahaba Research, Inc.
🇺🇸Birmingham, Alabama, United States
Boyett Health Services Inc
🇺🇸Hamilton, Alabama, United States
Longwood Research - Saadat Ansari, MD, LLC
🇺🇸Huntsville, Alabama, United States
Terence T. Hart, MD
🇺🇸Tuscumbia, Alabama, United States
Arrowhead Health Centers
🇺🇸Glendale, Arizona, United States
Phoenix Medical Research Institute, LLC
🇺🇸Peoria, Arizona, United States
Elite Clinical Studies
🇺🇸Phoenix, Arizona, United States
Clinical Research Institute of Arizona, LLC
🇺🇸Surprise, Arizona, United States
Scroll for more (210 remaining)Central Research Associates, Inc.🇺🇸Birmingham, Alabama, United States