safety and efficacy of mat9001(omega-3-pentaenoic acid) in subjects with triglycerides ≥500 mg/dl and <2000 mg/dl

Conditions: Severe Hypertriglyceridemia

Summary: to determine the efficacy of mat9001 compared to placebo in lowering fasting triglyceride levels in subjects with very high fasting triglyceride levels ≥ 500 and \< 2000 mg/dl.

this will be a 12-week, randomized, double blind, placebo-controlled safety and efficacy study in men and women ≥18 years of age with fasting triglycerides ≥500 mg/dl and \<2000 mg/dl while following a therapeutic lifestyle changes (tlc) diet.

Eligibility criteria:
inclusion criteria: * fasting triglycerides ≥500 mg/dl and \<2000 mg/dl * stable lipid-altering drug therapies permitted * stable pcsk9 inhibitor use permitted * bmi ≥20.0 kg/m2 * willing to maintain a therapeutic life change diet for the duration of the study * willing to maintain usual physical activity level for the duration of the study * willing to abstain from alcohol consumption for at least 24 hours prior to each study visit * agrees not to consume more than 2 meals/week containing fish or seafood * no plans to change smoking/vaping habits or other nicotine use during the study period * to be in generally good health on the basis of medical history, physical exam, electrocardiogram (ecg), and screening measurements exclusion criteria: * laboratory test result of clinical significance based on the judgment of the principal investigator * a clinically significant gi, endocrine, cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, or biliary disorder * known lipoprotein lipase impairment or deficiency or apo c2 deficiency or familial dysbetalipoproteinemia * acute or chronic pancreatitis * symptomatic gallstone disease (unless previously treated with cholecystectomy). * known nephrotic syndrome * malabsorption syndrome and/or chronic diarrhea * previous bariatric surgery or weight change \>3 kg (6.6 lb) during the lead in period. * diagnosed hereditary or acquired myopathy * uncontrolled diabetes (hba1c ≥9.5%) * uncontrolled hypertension (systolic blood pressure ≥160 mm hg and/or diastolic blood pressure ≥100 mm hg) * uncontrolled hypothyroidism, thyroid stimulating hormone \>5 miu/l * history of cancer in the prior 2 years, except non melanoma skin cancer or carcinoma in situ of the cervix * history of human immunodeficiency virus, hepatitis b, or hepatitis c infection. * active systemic infection. * history of paroxysmal atrial fibrillation, persistent atrial fibrillation, and/or history of ventricular tachycardic arrythmia (e.g., ventricular tachycardia/fibrillation) * history of a bleeding disorder * use of omega 3 drugs /supplements /fortified foods * use of bile acid sequestrants, fibrates, or niacin * use of dietary supplement(s) that alters lipid metabolism * use of weight management drug therapy * cardiovascular disease event (myocardial infarction or other acute coronary syndrome, stroke, transient ischemic attack), revascularization procedure * female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period * known allergy or sensitivity to any ingredients in the study products, including fish, seafood or omega 3 fatty acids * been exposed to any investigational drug product within 30 days * current or recent history or strong potential for illicit drug or excessive alcohol intake * a condition that would interfere with ability to provide informed consent or comply with the study protocol, or put the person at undue risk