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

Completed · Phase 3 · Has a placebo group

Conditions studied: Severe Hypertriglyceridemia

In brief

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.

Key facts

Study ID

NCT03011450

Run by

Kowa Research Institute, Inc.

People needed

471

Starts

2016-11-26

Expected to finish

2019-07-05

Last updated by the study team

2022-10-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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);

Where it is running

• 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
• iResearch — Little Rock, Arkansas, United States
• Lynn Institute of the Ozarks — Little Rock, Arkansas, United States
• Advanced Research Center — Anaheim, California, United States
• Torrance Clinical Research Institute Inc. — Lomita, California, United States
• Downtown L.A. Research Center, Inc. — Los Angeles, California, United States
• Catalina Research Institute, LLC — Montclair, California, United States
• Pacific Coast Cardiology and Research — Newport Beach, California, United States
• Lucita M. Cruz, MD., Inc. — Norwalk, California, United States
• Integrated Research Center — San Diego, California, United States
• Optimus Medical Group — San Francisco, California, United States
• Creekside Endocrine Associates, PC — Denver, Colorado, United States
• Atlantic Clinical Research Collaborative — Boynton Beach, Florida, United States
• ALL Medical Research, LLC — Cooper City, Florida, United States
• S & W Clinical Research — Fort Lauderdale, Florida, United States
• Indago Research and Health Center — Hialeah, Florida, United States
• Central Research Associates, Inc. — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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