A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event.

Inclusion Criteria:

- Men and non-pregnant or sterile women ages 45 and older

- Hypertriglyceridemia

- On statin therapy for at least four weeks

- Either having established Cardiovascular Disease or at high risk for Cardiovascular
Disease

Exclusion Criteria:

- Severe heart failure

- Any life-threatening disease other than Cardiovascular Disease

- Active severe liver disease

- Hemoglobin A1c >10.0%

- Poorly controlled hypertension

- Planned coronary intervention (such as stent placement or heart bypass) or any
non-cardiac major surgical procedure

- Known familial lipoprotein lipase deficiency (Fredrickson Type I), apolipoprotein C-II
deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III)

- Known hypersensitivity to the study product, fish and/or shellfish, or placebo

- History of acute or chronic pancreatitis

- Patients are excluded if using the following medications:

- PCSK9 inhibitors

- niacin >200 mg/day or fibrates;

- any omega-3 fatty acid medications ;

- dietary supplements containing omega-3 fatty acids (e.g., flaxseed oil, fish oil,
krill oil, or algal oil);

- bile acid sequestrants