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

Inclusion Criteria:

- Age ≥18 years or legal age of majority depending on regional law

- Fasting, calculated LDL-C at screening ≥160 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