study to evaluate the efficacy and safety of k-877 in adult patients with fasting high triglyceride levels and mild or moderate renal impairment

Conditions: Severe Hypertriglyceridemia

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 mild or moderate renal impairment.


Eligibility criteria:
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);