Safety and Efficacy Following Repeat-Dose of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis

Key Inclusion Criteria:

1. Previous documentation in the patient's medical records of a fasting serum TG
measurement ≥ 1000 mg/dL (11.3 mmol/L) on more than 1 occasion, and all fasting TG
values ≥500 mg/dL (5.6 mmol/L) at screening

2. History of a hospitalization and diagnosis of acute pancreatitis in the past 10 years

3. On stable lipid-modifying diet with or without medications (eg, statins, niacin,
omega-3 fatty acids). Lipid-modifying diet and doses of medications should be stable
for at least 4 weeks (6 weeks for fibrates, 8 weeks for PCSK9 inhibitors) prior to
screening

4. Body mass index (BMI) of 18-40 kg/m2

Key Exclusion Criteria:

1. A hospital or clinic discharge diagnosis of acute pancreatitis within 12 weeks of
screening

2. Lipid apheresis or plasma exchange treatment within the last 4 weeks or plans to
undergo apheresis or plasma exchange during the time frame of the study

3. History of class 3/4 heart failure at any time in the past, or hospitalization for
heart failure, diagnosis of a myocardial infarction, stroke, Transient ischemic attack
(TIA), unstable angina, Coronary artery bypass surgery (CABG), Percutaneous coronary
intervention (PCI), carotid surgery/stenting within 3 months before the screening
visit

4. History of bleeding disorders, esophageal varices, heparin induced thrombocytopenia,
or contraindications to receiving heparin (eg, allergic reaction to heparin)

5. Previous treatment with Glybera® in the past 5 years or treatment with lomitapide or
mipomersen in the past 6 months

6. Pregnant or breast feeding women

Note: Other protocol defined Inclusion/Exclusion criteria may apply