Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Normal Renal Function

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, criterion 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;

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);