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

• Status: Withdrawn
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Matinas Biopharma, Inc
• Collaborator: Covance

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