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| Name | Class |
|---|---|
| Matinas Biopharma, Inc | INDUSTRY |
| MB Clinical Research and Consulting LLC | UNKNOWN |
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Pharmacodynamic effects of MAT9001 compared to Vascepa in adults with hypertriglyceridemia
An open-label, randomized, crossover study to assess the pharmacodynamic effects of MAT-9001, an omega-3 free fatty acid compared to Vascepa (icosapent ethyl) on triglycerides and other lipoprotein lipids in men and women with elevated triglycerides.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3 pentaenoic acid (MAT9001) | Experimental | 2g MAT9001 capsules twice daily with meals |
|
| Icosapent ethyl (Vascepa) | Active Comparator | 2g Vascepa capsules twice daily with meals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega 3 pentaenoic acid | Drug | Encapsulated omega-3 pentaenoic acid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Plasma Triglycerides (Pharmacodynamic Population) | Percent change in triglycerides from baseline to end of treatment in the pharmacodynamic population | baseline to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population) | Percent change in other lipoprotein lipids from baseline to end of treatment in the pharmacodynamic population | baseline to 28 days |
| Percent Change in Lipoprotein Lipids (Per Protocol Population) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Maki | MB Clinical Research and Consulting | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Matinas Investigational Site | Jacksonville | Florida | 32216 | United States | ||
| Matinas Investigational site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35232215 | Derived | Maki KC, Bays HE, Ballantyne CM, Underberg JA, Kastelein JJP, Johnson JB, Ferguson JJ. A Head-to-Head Comparison of a Free Fatty Acid Formulation of Omega-3 Pentaenoic Acids Versus Icosapent Ethyl in Adults With Hypertriglyceridemia: The ENHANCE-IT Study. J Am Heart Assoc. 2022 Mar 15;11(6):e024176. doi: 10.1161/JAHA.121.024176. Epub 2022 Mar 1. |
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Crossover study - each patient received both treatments
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| ID | Title | Description |
|---|---|---|
| FG000 | MAT9001 Then Vascepa | 2g MAT9001 capsules twice daily with meals for 4 weeks; 4 week washout; 2 g Vascepa (icosapent ethyl) twice daily with meals for 4 weeks Crossover design - Patients in this arm received initial treatment with MAT9001, a washout period, and treatment with Vascepa |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 21, 2019 | Feb 7, 2022 |
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| icosapent ethyl | Drug | Encapsulated omega-3 acid ethyl esters |
|
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Percent change from baseline in lipoprotein lipids in the per protocol population |
| baseline to 28 days |
| Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population) | The percent change from baseline in Apolipoproteins, PCSK9 and hs-CRP in the PD Population | baseline to 28 days |
| Percent Change From Baseline in Omega-3 Fatty Acid Concentrations (Pharmacodynamic Population) | The percent change from baseline in Omega-3 fatty acid concentrations in the Pharmacodynamic population | Baseline to 28 days |
| Jupiter |
| Florida |
| 33458 |
| United States |
| Matinas Investigational Site | Port Saint Lucie | Florida | 34952 | United States |
| Matinas Investigational Site | Addison | Illinois | 60101 | United States |
| Matinas Investigational Site | Chicago | Illinois | 60640 | United States |
| Matinas Investigational site | Indianapolis | Indiana | 46260 | United States |
| Matinas Investigational site | Louisville | Kentucky | 40213 | United States |
| Matinas Investigational site | Richmond | Virginia | 23294 | United States |
| Vascepa Then MAT9001 |
2g Vascepa (icosapent ethyl) twice daily with meals for 4 weeks; 4 week washout; MAT9001 2g twice daily with meals for 4 weeks Crossover design - Patients were randomized to receive initial treatment with Vascepa, a washout period, and treatment with MAT9001 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Study Population | All patients received both treatments |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (kg/m^2) | Mean | Standard Deviation | kg/m2 |
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| Lipid Drugs | Count of Participants | Participants |
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| Triglyceride stratification | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Plasma Triglycerides (Pharmacodynamic Population) | Percent change in triglycerides from baseline to end of treatment in the pharmacodynamic population | All patients with measurable results who received both drugs | Posted | Median | Inter-Quartile Range | Percent Change from baseline | baseline to 28 days |
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| Secondary | Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population) | Percent change in other lipoprotein lipids from baseline to end of treatment in the pharmacodynamic population | All patients with measurable results who received both drugs | Posted | Median | Inter-Quartile Range | Percent Change from baseline | baseline to 28 days |
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| Secondary | Percent Change in Lipoprotein Lipids (Per Protocol Population) | Percent change from baseline in lipoprotein lipids in the per protocol population | All patients who had measurable values for both treatments and had at least 80% compliance with study medication | Posted | Median | Inter-Quartile Range | Percent Change from baseline | baseline to 28 days |
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| Secondary | Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population) | The percent change from baseline in Apolipoproteins, PCSK9 and hs-CRP in the PD Population | All patients with measurable values who received both therapies | Posted | Median | Inter-Quartile Range | Percent Change from baseline | baseline to 28 days |
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| Secondary | Percent Change From Baseline in Omega-3 Fatty Acid Concentrations (Pharmacodynamic Population) | The percent change from baseline in Omega-3 fatty acid concentrations in the Pharmacodynamic population | Pharmacodynamic population - all patients with measurable values who received both drugs | Posted | Median | Inter-Quartile Range | Percent Change from baseline | Baseline to 28 days |
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Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omega-3 Pentaenoic Acid (MAT9001) | 2g MAT9001 capsules twice daily with meals Omega 3 pentaenoic acid: Encapsulated omega-3 pentaenoic acid | 0 | 97 | 0 | 97 | 43 | 97 |
| EG001 | Icosapent Ethyl (Vascepa) | 2g Vascepa capsules twice daily with meals icosapent ethyl: Encapsulated omega-3 acid ethyl esters | 0 | 100 | 0 | 100 | 28 | 100 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Total GI Disorders | Gastrointestinal disorders | Systematic Assessment |
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| Total Infections | Infections and infestations | Systematic Assessment |
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| Total Injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Total Musculoskeletal Disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Total Nervous System Disorders | Nervous system disorders | Systematic Assessment |
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| cataract | Eye disorders | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Eructation | Gastrointestinal disorders | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Urinary Tract infection | Infections and infestations | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James J Ferguson, MD | Matinas BioPharma | (908) 505-0964 | jferguson@matinasbiopharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 7, 2020 | Feb 7, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000723968 | MAT9001 |
| C035276 | eicosapentaenoic acid ethyl ester |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Both statin and ezetimibe |
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