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

Phase 3

Completed

Brief Summary: 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).

Recruitment & Eligibility

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 screening
Other protocol specific inclusion criteria may apply

Exclusion Criteria

Females who are pregnant or breast-feeding or who have a positive pregnancy test (urine) result at screening or baseline visits
Patients 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 visit
Uncontrolled hypertension, defined as sitting systolic blood pressure after resting 5 minutes of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg at screening
Patients with uncontrolled and serious hematologic or coagulation disorders or with hemoglobin of <10.0 g/dL at screening
Patients with uncontrolled diabetes with HbA1c of ≥9% at screening
Patients with uncontrolled hypothyroidism with thyroid-stimulating hormone (TSH) of >1.5 × ULN at screening
Patients with liver disease or dysfunction, including:
- Positive serology for hepatitis B surface antigen (HBsAg) or a positive hepatitis C virus (HCV) antibody test at screening
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of ≥3 × ULN or total bilirubin of ≥2 × ULN at screening
Patients with creatine kinase (CK) of >3 × ULN at screening
Patients 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 screening
Other protocol specific exclusion criteria may apply

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
ETC-1002 180mg	180mg of ETC-1002(bempedoic acid)	-

Primary Outcome Measures

Name	Time	Method
Percent Change in LDL-C From Baseline to Week 12	Baseline, week12	Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week -1 and Day 1.

Secondary Outcome Measures

Name	Time	Method
Percent Change in Non-HDL Cholesterol From Baseline to Week 12	Baseline, week12	Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100.
Percent Change in Total Cholesterol From Baseline to Week 12	Baseline, week12	Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100.
Percent Change in Apolipoprotein B From Baseline to Week 12	Baseline, week12	Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100.
Percent Change in Hemoglobin A1c From Baseline to Week 12	Baseline, week12	Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100.
Percent Change in High Sensitivity C Reactive Protein From Baseline to Week 12	Baseline, week12	Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100.
Proportion of Subjects Whose LDL-C Value Achieved the Lipid Management Goals Based on Risk Assessment at Week 12	Baseline, week12	The proportion of subjects whose LDL-C value achieves the lipid management goal at Week 12.