A Phase 3 STudy of CaPRe In LOwering Very hiGh TriglYcerides (TRILOGY 1)

Inclusion Criteria:

1. Subjects ≥18 years of age.

2. Isolated hypertriglyceridemia, with triglycerides ≥500 mg/dL and <1500 mg/dL (≥5.7mmol/L and <17.0 mmol/L) OR Mixed hyperlipidemia, with serum triglycerides ≥500 and <1500 mg/dL treated with a statin, CAI or PCSK9I inhibitor, alone or in combination,that has been stable for 6 weeks prior to randomization. If the subject is not beingtreated and not contraindicated, a statin and/or CAI treatment may be initiated at thediscretion of the Investigator at time of screening.

3. Willingness to maintain current physical activity level and follow the NCEP-TLC dietthroughout the study.

4. Be informed of the nature of the study and give written consent prior to any studyprocedure.

Exclusion Criteria:

1. Allergy or intolerance to OM3 fatty acids, OM3-acid ethyl esters, OM3 phospholipids,fish, shell fish, or any component of the study medication.

2. Known lipoprotein lipase impairment or deficiency, or apo CII deficiency.

3. Subjects with lysosomal acid lipase deficiency.

4. Body mass index greater than 45 kg/m2.

5. Subjects who are pregnant, lactating, and subjects of childbearing potential who areeither planning to become pregnant or who are not using acceptable birth controlmethods during study participation. Subjects of childbearing potential are subjectswho have experienced menarche and do not otherwise meet the criteria for subjects notof childbearing potential, defined as:

• Subjects who have had surgical sterilization (hysterectomy or bilateraloophorectomy or tubal ligation); or

• Subjects who are postmenopausal, i.e., who have had a cessation of menses for atleast 12 months without an alternative medical cause. A follicle stimulatinghormone (FSH) test ≥40 mIU/mL may be used to confirm the post-menopausal state inwomen not using hormonal contraception or hormonal replacement therapy. Subjects of childbearing potential must test negative for pregnancy at the time ofenrollment and agree to use an acceptable contraceptive method or remain abstinentduring the study or for at least 8 weeks following the last dose of study medication,whichever is longer.

6. Subjects taking tamoxifen, estrogens, or progestins, or other medications ornutritional supplements with mechanisms modifying estrogen or progestogen pathways,who have had dosage changes within 4 weeks prior to Visit 1.

7. Use of oral or injected corticosteroids or anabolic steroids within 6 weeks prior torandomization.

8. History of pancreatitis within the last 6 months prior to Visit 1.

9. History of symptomatic gallstone disease within the last 5 years, unless treated withcholecystectomy.

10. Diabetics requiring changes in medical therapy (other than short acting insulin dosageadjustments) within 6 weeks prior to Visit 1 or who have HbA1c greater than 9.5% atVisit 1.

11. Clinical or biochemical evidence of hyperthyroidism not stable with medication for atleast 6 weeks prior to Visit 1.

12. Uncontrolled hypothyroidism or thyroid stimulating hormone (TSH) level more than 1.5 ×upper limit of normal (ULN).

13. Thyroid hormone replacement therapy that has not been stable for more than 6 weeksprior to Visit 1.

14. History of cancer (other than basal cell carcinoma) within 2 years prior to Visit 1.

15. Cardiovascular event (i.e., myocardial infarction, acute coronary syndrome, new onsetangina, stroke, transient ischemic attack, exacerbation of congestive heart failurerequiring hospitalization or a change in treatment), life threatening arrhythmia, orrevascularization procedure within 6 months prior to Visit 1.

16. Use of other prohibited drugs: weight loss prescription medications; humanimmunodeficiency virus (HIV) protease inhibitors; cyclophosphamide; isotretinoin;routine or anticipated use of systemic corticosteroids (local, topical, inhalation, ornasal corticosteroids are permitted); or anabolic steroids.

17. Use of any lipid-altering drug therapy, other than statins, CAI (such as ezetimibe) orPCSK9I inhibitors, alone or in combination, including niacin at a dose greater than 200 mg/day, fibrates, bile acid sequestrants, OM3 drugs (e.g., Lovaza or itsgenerics,Vascepa, Epanova, Omtryg), OM3 supplements (e.g., fish oil, krill oilproducts), or any other herbal products or dietary supplements with potentiallipid-altering effects. These products must be discontinued at least 6 weeks prior torandomization.

18. Resection of an aortic aneurysm or endovascular aortic repair within 6 months prior toVisit 1.

19. Recent history (within 6 months prior to Visit 1) or current significant nephroticsyndrome or ≥3 gram proteinuria daily, pulmonary, gastrointestinal, or immunologicdisease.

20. Poorly controlled hypertension (systolic blood pressure ≥170 mmHg and/or diastolicblood pressure ≥100 mmHg). Subjects with hypertension adequately controlled withmedication are eligible provided that their antihypertensive therapy has been stablefor at least 4 weeks prior to Visit 1.

21. Recent history (past 12 months) of drug abuse or alcohol abuse, or alcohol use greaterthan 2 units per day (a unit of alcohol is defined as a 12-ounce (350 mL) beer, 5ounce (150 mL) wine, or 1.5-ounce (45 mL) of 80-proof alcohol for drinks).

22. Hepatobiliary disease or serum alanine aminotransferase (ALT) or aspartateaminotransferase (AST) >5× ULN; if ALT/AST is >3× ULN, the levels must have beenstable for 3 months prior to Visit 1.

23. Severe renal disease as defined by less than 30 mL/min serum creatinine clearancecalculated using the Cockcroft-Gault formula.

24. Significant coagulopathy as defined by a known hereditary deficiency of coagulationfactors or platelet function or an unexplained elevation of the prothrombin time (PT)international normalized ratio (INR) of ≥1.5. Subjects using warfarin [Coumadin®] orheparin are allowed. Subjects receiving other anticoagulants dabigatran, rivaroxaban,or apixaban are allowed. Subjects receiving acetylsalicylic acid (ASA) alone or incombination with other anti platelet agents (e.g., clopidogrel, prasugrel, ticagrelor)are also allowed.

25. Unexplained creatine kinase concentration 3 × ULN.

26. Creatine kinase elevation owing to known hereditary or acquired muscle disease.

27. Exposure to any investigational product, within 4 weeks prior to Visit 1.

28. Presence of any other condition the Investigator believes would interfere with thesubject's ability to provide informed consent, comply with study instructions, orwhich might confound the interpretation of the study results or put the subject atundue risk.

29. Any life-threatening disease expected to result in death within 2 years, requirefrequent hospitalizations, extensive surgery or changes in medications or diet.