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

Severe Hypertriglyceridemia Clinical Trial

— AMPLIFY  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04662528
• Other study ID #: MAT-003
• Status: Withdrawn
• Phase: Phase 3
• Start date: June 2021
• Est. completion date: October 2022

Study information

• Verified date: September 2021
• Source: Matinas Biopharma, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertriglyceridemia
• Severe Hypertriglyceridemia

Intervention

Drug:
• Placebo
4 x 1g capsules/day
• MAT9001 (omega-3 pentaenoic acid)
4 x 1g capsules/day

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Matinas Biopharma, Inc	Covance

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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