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

Matinas BioPharma

Status and phase

Withdrawn

Phase 3

Conditions

Severe Hypertriglyceridemia

Treatments

Drug: Placebo

Drug: MAT9001 (omega-3 pentaenoic acid)

Study type

Interventional

Funder types

Industry

Identifiers

NCT04662528

MAT-003

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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