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

Study Overview
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Brief Summary
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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).

Official Title
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A Placebo-controlled, Randomized, Multicenter, Double-blind, Parallel-group Trial to Confirm the Superiority of ETC-1002 in Patients With Hyper-LDL Cholesterolemia

Conditions
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Hyper-low-density Lipoprotein (LDL) Cholesterolemia

Intervention / Treatment
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* Drug: 180mg of ETC-1002(bempedoic acid)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ETC-1002 180mg<br> | Drug: 180mg of ETC-1002(bempedoic acid)<br>* 180mg, tablet, once daily, for 12 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* placebo, tablet, once daily, for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in LDL-C from baseline at Week 12 |  | Baseline, week12 |