Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg When Added to PCSK9 Inhibitor Therapy

A Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg QD When Added to Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)-Inhibitor Therapy

The purpose of this study is to determine if bempedoic acid (ETC-1002) 180mg added to PCSK9 inhibitor (evolocumab) therapy is effective and safe in patients with elevated LDL cholesterol.

Inclusion Criteria:

• Age ≥18 years or legal age of majority depending on regional law
• Fasting, calculated LDL-C at screening ≥160 mg/dL and following PCSK9i therapy ≥70 mg/dL
• Men and nonpregnant, nonlactating women

Exclusion Criteria:

• Heterozygous (HeFH) or Homozygous (HoFH) Familial Hypercholesterolemia
• Total fasting TG ≥500 mg/dL
• Renal dysfunction or a glomerulonephropathy; eGFR <30 mL/min/1.73 m2
• Known cardiovascular disease (CVD), peripheral arterial disease (PAD), or cerebrovascular disease (CD)
• History of type 1 or type 2 diabetes
• Uncontrolled hypertension
• Uncontrolled hypothyroidism
• Liver disease or dysfunction
• Gastrointestinal conditions or procedures (including Lap-Band® or gastric bypass)
• History of hematologic or coagulation disorders
• History of malignancy (except non-metastatic basal or squamous cell carcinoma of the skin and cervical carcinoma in situ)
• Unexplained creatine kinase (CK) >3 × ULN
• Use of a cholesterylester transfer protein (CETP) inhibitor in the last 12 months prior to screening, such as: anacetrapib, dalcetrapib, or evacetrapib
• Pregnant or breast feeding, or planning to become pregnant during treatment and/ or within 30 days after the end of treatment