Trial Assessing Evolocumab(AMG145) Compared to LDL-C Apheresis in Subjects Receiving LDL-C Apheresis Prior to Study Enrollment

Inclusion Criteria:

- Male or female, ≥ 18 years of age

- Subject has been receiving regular apheresis for LDL-C lowering for at least 3 months
immediately prior to lipid screening and has a treatment goal of LDL-C < 100 mg/dL
(2.6 mmol/L), and has been receiving LDL-C apheresis during the last ≥ 4 weeks prior
to lipid screening at regular QW or Q2W schedule and with no changes in apheresis
type

- Subject is receiving lipid-lowering pharmacological background therapy which includes
a high-intensity statin dose (moderate-intensity statin dose with attestation that a
higher dose is not appropriate for the subject) unless the subject has a history of
statin intolerance

- Lipid-lowering therapy status (ie, any therapy for lowering lipids, including
apheresis type and frequency) must be unchanged for ≥ 4 weeks prior to LDL-C
screening

- Pre-apheresis LDL-C is ≥ 100 mg/dL (≥ 2.6 mmol/L) and ≤ 190 mg/dL (≤ 4.9 mmol/L) at
screening

- Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L) at screening.

Exclusion criteria:

- Known homozygous familial hypercholesterolemia

- Missing any apheresis session is medically contraindicated or inappropriate

- Stopping apheresis would be inappropriate in the opinion of the investigator even if
LDL-C is controlled to < 100 mg/dL with other therapies

- Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI),
coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization.

- Uncontrolled hypertension