- Males and females at the age or over 18 years of age.
- With primary hyperlipidemia or mixed dyslipidemia.
- Treated with stable daily dose of statins
- At high or very high risk of incurring a CV event
- Fasting LDL-C >=70 mg/dL (1.81 mmol/L) for subjects on the highest approved dose of
statins; Fasting LDL C >=77 mg/dL (1.99 mmol/L) for subjects not on highest approved
dose.
- Fasting TG ≤400 mg/dL (4.51 mmol/L)
- Prior exposure to bococizumab or other investigational PCSK9 inhibitor
- NYHA class IV, or Left Ventricular Ejection Fraction
- Poorly controlled hypertension
- History of hemorrhagic stroke or lacunar infarction resulting in a stroke
- Untreated hyperthyroidism or TSH >1 × ULN
- Undergoing apheresis or have planned start of apheresis.