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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Severe Hypertriglyceridemia

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: MAT9001 (omega-3 pentaenoic acid)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 4 x 1g capsules/day<br>|
| Experimental: MAT9001 (omega-3-pentaenoic acid)<br> | Drug: MAT9001 (omega-3 pentaenoic acid)<br>* 4 x 1g capsules/day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent change from baseline to end of study for MAT9001 versus Placebo | Difference between MAT9001 and placebo treatment groups in triglyceride lowering effect | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent change from baseline to end of study for lipids and lipid biomarkers for MAT9001 versus Placebo | Difference between MAT9001 and placebo treatment groups in other lipid and biomarker levels | 12 weeks |