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