Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment

Kowa Research Institute, Inc.471 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

471

Conditions

Severe Hypertriglyceridemia

Interventions

K-877DRUG

FenofibrateDRUG

Placebo (for K-877)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Able to understand and willing to comply with all study requirements and procedures throughout the duration of the study and give written informed consent; 2. Aged ≥18 years; 3. 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): 1. 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); 2. 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); 3. 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 4. 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; 4. Patients currently on a low-intensity statin or not on a statin, must meet one of the following criteria; 1. Patient does not meet any criteria for moderate- or high-intensity statin therapy listed above (see inclusion criteria, 3.a. through 3.d.); 2. 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 3. 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; 5. 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 Exclusion Criteria: 1. 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; 2. Body mass index (BMI) \>45 kg/m2 at Visit 1 (Week -8 or Week -6); 3. Patients with type 1 diabetes mellitus; 4. 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);

Locations (241)

Outcomes

Primary Outcomes

Percent Change in Fasting TG From Baseline to Week 12

Time frame: 12 Weeks

Secondary Outcomes

Percent Change From Baseline to Week 12 in Remnant Cholesterol

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in HDL-C

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Apo A1

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Non-HDL-C

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Total Cholesterol

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in LDL-C

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in FFAs

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Apo A2

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Apo B

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Apo B48

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Apo B100

Data from ClinicalTrials.gov

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Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Apo C2

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Apo C3

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Apo E

Time frame: 12 Weeks

Change From Baseline to Week 12 in FGF21

Time frame: 12 Weeks

Change From Baseline to Week 12 in hsCRP

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Large)

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Intermediate)

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Small)

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 1)

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 2)

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins I)

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIa)

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIb)

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIa)

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIb)

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVa)

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVb)

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVc)

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 2b)

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 3 and 2a)

Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction.

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Ion Mobility (Diameter of the Major LDL Particle (Å))

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Particles)

Two types of lipoprotein particles were analyzed together as one measurement without distinction.

Time frame: 12 Weeks

Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Particles-Large)

Two types of lipoprotein particles were analyzed together as one measurement without distinction.

Time frame: 12 Weeks

Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Medium)

Time frame: 12 Weeks

Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Small)

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles)

Time frame: 12 Weeks

Change From Baseline to Week 12 in Lipoprotein Fraction (IDL Particles)

Time frame: 12 Weeks

Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Large)

Time frame: 12 Weeks

Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Small)

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles)

Time frame: 12 Weeks

Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Large)

Time frame: 12 Weeks

Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Medium)

Time frame: 12 Weeks

Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Small)

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particle Size)

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particle Size)

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particle Size)

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Lipoprotein Fraction (Triglyceride)

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Triglyceride)

Two types of lipoprotein particles were analyzed together as one measurement without distinction.

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Lipoprotein Fraction HDL Cholesterol (Total)

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TG:HDL-C

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TC:HDL-C

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C

Time frame: 12 Weeks

Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo B:Apo A1

Time frame: 12 Weeks

Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2

Time frame: 12 Weeks

Percent Change From Baseline to Week 52 in Fasting TG

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Remnant Cholesterol

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in HDL-C

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Apo A1

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Non-HDL-C

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in TC

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in LDL-C

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in FFAs

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Apo A2

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Apo B

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Apo B48

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Apo B100

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Apo C2

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Apo C3

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Apo E

Time frame: 52 Weeks

Change From Baseline to Week 52 in FGF21

Time frame: 52 Weeks

Change From Baseline to Week 52 in hsCRP

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Large)

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Intermediate)

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Small)

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 1)

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 2)

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins I)

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIa)

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIb)

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIa)

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIb)

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVa)

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVb)

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVc)

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Ion Mobility (High Density Lipoproteins 2b)

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Ion Mobility (High Density Lipoproteins 3 and 2a)

Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction.

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Ion Mobility (Diameter of the Major LDL Particle (Å))

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Particles)

Two types of lipoprotein particles were analyzed together as one measurement without distinction.

Time frame: 52 Weeks

Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Particles-Large)

Two types of lipoprotein particles were analyzed together as one measurement without distinction.

Time frame: 52 Weeks

Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Medium)

Time frame: 52 Weeks

Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Small)

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles)

Time frame: 52 Weeks

Change From Baseline to Week 52 in Lipoprotein Fraction (IDL Particles)

Time frame: 52 Weeks

Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Large)

Time frame: 52 Weeks

Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Small)

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles)

Time frame: 52 Weeks

Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Large)

Time frame: 52 Weeks

Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Medium)

Time frame: 52 Weeks

Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Small)

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particle Size)

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particle Size)

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particle Size)

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Lipoprotein Fraction (Triglyceride)

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Triglyceride)

Two types of lipoprotein particles were analyzed together as one measurement without distinction.

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Cholesterol)

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TG:HDL-C

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TC:HDL-C

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C

Time frame: 52 Weeks

Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo B:Apo A1

Time frame: 52 Weeks

Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2

Time frame: 52 Weeks