Assess the Safety and Efficacy of NKPL66 (CaPre™) in the Treatment of Mild-to-high Hypertriglyceridemia

Exclusion Criteria

• •Any concomitant medication which in the opinion of the investigator would preclude the patient from successfully participating in the study;
• •Women who are pregnant or that are breast feeding;
• •Participation in another clinical trial within 30 days from initiation of the study;
• •Participants with a high risk for cardiovascular disease; (The definition of high-risk individuals will follow that of the 2009 Canadian Guidelines and include a) FRS \>= 20% 10-year risk; b) All patients with uncontrolled diabetes (DCA guidelines) and c) Evidence of atherosclerosis -when this evidence was ascertained when clinically indicated);
• •Systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg. In diabetic patients, systolic blood pressure \> 130 mmHg and/or diastolic blood pressure \> 90 mmHg.
• •History of stroke, intermittent claudication or transient ischemic attack;
• •Known unstable (uncontrolled) cardiac disease, within the last 6 months:
• •Patient with a clinically significant abnormal ECG at screening.
• •Patients with uncontrolled diabetes mellitus, with HbA1c \> 7.0%;
• •Known diagnosis of hypoglycemia
• •Evidence of active renal disease indicated by a fasting estimated glomerular filtration rate (eGFR) of \< 60 ml/min per 1.73 m2;
• •Increased plasma levels (\>ULN) of amylase (as per respective lab upper limits) and / or lipase (\>160 IU/L) or any indication of pancreatitis (increased alcohol consumption, gallstones);
• •History of pancreatitis;
• •Use of any lipid lowering medication other than statins (e.g niacin, fibrates or ezetimibe) and/or lipid lowering NHP within 6 weeks prior to the screening visit;
• •Intake of \> 2 servings per week of fish or regimented use of fish oil/omega-3 supplements within 6 weeks prior to the screening visit;
• •Intake of fortified foods containing plant sterols within 6 weeks prior to the screening visit;
• •Known HIV or Hepatitis B or C positive;
• •Patients with osteoporosis and hormone sensitive conditions;
• •Patients with uncontrolled asthma as defined by the 2010 Consensus Summary of the Canadian Thoracic Society;
• •Known seafood allergy or allergy to any of the medicinal or non-medicinal ingredients of the study medication, including:
• •* Omega-3 fatty acids (including EPA and DHA)
• •* Phospholipids (mainly phosphatidylcholine)
• •* Astaxanthin
• •* Bovine gelatin
• •Coagulopathy or on anticoagulants. Platelet aggregation inhibitors (such as aspirin or clopidogrel but not heparin) are permitted in the study; patients taking both aspirin and clopidogrel are not permitted in the study;
• •Unable or unwilling to comply with the protocol;
• •Patient reported weight must be stable for the past 6 months (within 3kg variation);
• •Consumption of more than 14 standard alcoholic drinks a week.