A Confirmatory Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia

The purpose of this study is to confirm the superiority of ETC-1002 after 12 weeks of administration at 180 mg/day to placebo in patients with hyper-LDL cholesterolemia who have inadequate control of low-density lipoprotein cholesterol (LDL C).

Inclusion Criteria:Patients with inadequate response to statins or statin intolerance as defined below [Inadequate response to statins] Patients with hyper-LDL cholesterolemia who have been taking statins[and other lipid-modifying therapies(LMTs) if needed] and cannot achieve the lipid management goals of LDL-C [Statin intolerance] Patients with hyper-LDL cholesterolemia for whom safety problems have occurred while taking at least one type of statin, and who experienced resolution of the problems after discontinuation or dose reduction, and who cannot achieve the lipid management goals of LDL-C. Patients must be on the lowest or under the dosage of the approved dose of statin and/or on stable LMT(s).Patients with fasting TG levels of <400 mg/dL at screeningOther protocol specific inclusion criteria may applyExclusion Criteria:Females who are pregnant or breast-feeding or who have a positive pregnancy test (urine) result at screening or baseline visitsPatients with homozygous familial hypercholesterolemia (HoFH)Patients who currently have or who have had within the past 3 months prior to screening any cardiovascular diseases, or those who have developed any cardiovascular diseases during the screening or before baseline visitUncontrolled hypertension, defined as sitting systolic blood pressure after resting 5 minutes of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg at screeningPatients with uncontrolled and serious hematologic or coagulation disorders or with hemoglobin of <10.0 g/dL at screeningPatients with uncontrolled diabetes with HbA1c of ≥9% at screeningPatients with uncontrolled hypothyroidism with thyroid-stimulating hormone (TSH) of >1.5 × ULN at screeningPatients with liver disease or dysfunction, including:Positive serology for hepatitis B surface antigen (HBsAg) or a positive hepatitis C virus (HCV) antibody test at screeningAlanine aminotransferase (ALT) or aspartate aminotransferase (AST) of ≥3 × ULN or total bilirubin of ≥2 × ULN at screeningPatients with creatine kinase (CK) of >3 × ULN at screeningPatients with a history or current renal dysfunction, nephritic syndrome, or nephritis, and with estimated glomerular filtration rate (eGFR) of ≤30 mL/min/1.73 m2 at screeningOther protocol specific exclusion criteria may apply