Reduction of Low-Density Lipoprotein Cholesterol (LDL-C) With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Subject With Heterozygous Familial Hypercholesterolemia

The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with placebo, on percent change from baseline in LDL-C in adults with heterozygous familial hypercholesterolemia (HeFH).

Inclusion Criteria:

• Male or female ≥ 18 to ≤ 75 years of age
• Diagnosis of heterozygous familial hypercholesterolemia by having met the diagnostic criteria outlined by the Simon Broome Register Group (Scientific Steering Committee 1991)
• On an approved statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks
• Fasting Low-Density Lipoprotein Cholesterol (LDL-C) ≥ 100 mg/dL
• Fasting triglycerides ≤ 400 mg/dL

Exclusion Criteria:

• Homozygous familial hypercholesterolemia
• Low-Density Lipoprotein (LDL) or plasma apheresis within 12 months prior to randomization
• New York Heart Association (NYHA) III or IV heart failure, or known left ventricular ejection fraction < 30%
• Uncontrolled cardiac arrhythmia
• Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
• Type 1 diabetes; newly diagnosed or poorly controlled type 2 diabetes (HbA1c > 8.5%)
• Uncontrolled hypertension