Severe Hypertriglyceridemia
Conditions
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.
Interventions
DRUGPlacebo
4 x 1g capsules/day
DRUGMAT9001 (omega-3 pentaenoic acid)
4 x 1g capsules/day
Sponsors
Covance
Matinas Biopharma, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percent change from baseline to end of study for MAT9001 versus Placebo | 12 weeks | Difference between MAT9001 and placebo treatment groups in triglyceride lowering effect |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The percent change from baseline to end of study for lipids and lipid biomarkers for MAT9001 versus Placebo | 12 weeks | Difference between MAT9001 and placebo treatment groups in other lipid and biomarker levels |
Outcome results
None listed