Status:
WITHDRAWN
Safety and Efficacy of MAT9001(Omega-3-pentaenoic Acid) in Subjects With Triglycerides ≥500 mg/dL and <2000 mg/dL
Lead Sponsor:
Matinas Biopharma, Inc
Collaborating Sponsors:
Covance
Conditions:
Severe Hypertriglyceridemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04662528
Start Date
June 1 2021
End Date
October 1 2022
Last Update
September 16 2021
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