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 (≥5.7
mmol/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 being
treated and not contraindicated, a statin and/or CAI treatment may be initiated at the
discretion of the Investigator at time of screening.

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

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

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 are
either planning to become pregnant or who are not using acceptable birth control
methods during study participation. Subjects of childbearing potential are subjects
who have experienced menarche and do not otherwise meet the criteria for subjects not
of childbearing potential, defined as:

- Subjects who have had surgical sterilization (hysterectomy or bilateral
oophorectomy or tubal ligation); or

- Subjects who are postmenopausal, i.e., who have had a cessation of menses for at
least 12 months without an alternative medical cause. A follicle stimulating
hormone (FSH) test ≥40 mIU/mL may be used to confirm the post-menopausal state in
women not using hormonal contraception or hormonal replacement therapy.

Subjects of childbearing potential must test negative for pregnancy at the time of
enrollment and agree to use an acceptable contraceptive method or remain abstinent
during 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 or
nutritional 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 to
randomization.

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 with
cholecystectomy.

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

11. Clinical or biochemical evidence of hyperthyroidism not stable with medication for at
least 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 weeks
prior 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 onset
angina, stroke, transient ischemic attack, exacerbation of congestive heart failure
requiring hospitalization or a change in treatment), life threatening arrhythmia, or
revascularization procedure within 6 months prior to Visit 1.

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

17. Use of any lipid-altering drug therapy, other than statins, CAI (such as ezetimibe) or
PCSK9I 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 its
generics,Vascepa, Epanova, Omtryg), OM3 supplements (e.g., fish oil, krill oil
products), or any other herbal products or dietary supplements with potential
lipid-altering effects. These products must be discontinued at least 6 weeks prior to
randomization.

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

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

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

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

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

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

24. Significant coagulopathy as defined by a known hereditary deficiency of coagulation
factors or platelet function or an unexplained elevation of the prothrombin time (PT)
international normalized ratio (INR) of ≥1.5. Subjects using warfarin [Coumadin®] or
heparin are allowed. Subjects receiving other anticoagulants dabigatran, rivaroxaban,
or apixaban are allowed. Subjects receiving acetylsalicylic acid (ASA) alone or in
combination 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 the
subject's ability to provide informed consent, comply with study instructions, or
which might confound the interpretation of the study results or put the subject at
undue risk.

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