- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04662528
Safety and Efficacy of MAT9001(Omega-3-pentaenoic Acid) in Subjects With Triglycerides ≥500 mg/dL and <2000 mg/dL (AMPLIFY)
September 9, 2021 updated by: Matinas Biopharma, Inc
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
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
4 x 1g capsules/day
|
Experimental: MAT9001 (omega-3-pentaenoic acid)
|
4 x 1g capsules/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The percent change from baseline to end of study for MAT9001 versus Placebo
Time Frame: 12 weeks
|
Difference between MAT9001 and placebo treatment groups in triglyceride lowering effect
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The percent change from baseline to end of study for lipids and lipid biomarkers for MAT9001 versus Placebo
Time Frame: 12 weeks
|
Difference between MAT9001 and placebo treatment groups in other lipid and biomarker levels
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Judith Johnson, Matinas BioPharma
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2021
Primary Completion (Anticipated)
August 1, 2022
Study Completion (Anticipated)
October 1, 2022
Study Registration Dates
First Submitted
December 4, 2020
First Submitted That Met QC Criteria
December 4, 2020
First Posted (Actual)
December 10, 2020
Study Record Updates
Last Update Posted (Actual)
September 16, 2021
Last Update Submitted That Met QC Criteria
September 9, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MAT-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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