Safety and Efficacy of MAT9001(Omega-3-pentaenoic Acid) in Subjects With Triglycerides ≥500 mg/dL and <2000 mg/dL

A Phase 3, Placebo-Controlled, Randomized, Double-blind, Parallel-arm Trial to Assess the Safety and Efficacy of MAT9001 in Subjects With Severe Hypertriglyceridemia: The AMPLIFY Trial

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.

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