Hypertriglyceridemia
Conditions
Brief summary
Pharmacodynamic effects of MAT9001 compared to Vascepa in adults with hypertriglyceridemia
Detailed description
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.
Interventions
DRUGOmega 3 pentaenoic acid
Encapsulated omega-3 pentaenoic acid
DRUGicosapent ethyl
Encapsulated omega-3 acid ethyl esters
Sponsors
Matinas Biopharma, Inc
MB Clinical Research and Consulting LLC
Matinas BioPharma Nanotechnologies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, ≥18 y of age * Judged to be in generally good health * Fasting triglycerides ≥150 mg/dL to ≤499 mg/dL during screening * Body mass index of ≥20.0 kg/m2 * No clinically significant findings in a 12-lead ECG or physical examination * Willing and able to undergo the scheduled study procedures * Understands study procedures and signs forms documenting informed consent to participate in the study
Exclusion criteria
* Laboratory test result of clinical significance * Uncontrolled hypertension * Clinically significant gastrointestinal, endocrine, cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, or biliary disorder * History of human immunodeficiency virus, hepatitis B or hepatitis C infection * Used any medication intended to alter the lipid profile within 4 weeks of the first qualification visit * Active systemic infection * A condition the Investigator believes would interfere subject ability to provide informed consent and/or comply with the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Plasma Triglycerides (Pharmacodynamic Population) | baseline to 28 days | Percent change in triglycerides from baseline to end of treatment in the pharmacodynamic population |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population) | baseline to 28 days | Percent change in other lipoprotein lipids from baseline to end of treatment in the pharmacodynamic population |
| Percent Change in Lipoprotein Lipids (Per Protocol Population) | baseline to 28 days | Percent change from baseline in lipoprotein lipids in the per protocol population |
| Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population) | baseline to 28 days | The percent change from baseline in Apolipoproteins, PCSK9 and hs-CRP in the PD Population |
| Percent Change From Baseline in Omega-3 Fatty Acid Concentrations (Pharmacodynamic Population) | Baseline to 28 days | The percent change from baseline in Omega-3 fatty acid concentrations in the Pharmacodynamic population |
Countries
United States
Participant flow
Pre-assignment details
Crossover study - each patient received both treatments
Participants by arm
| Arm | Count |
|---|---|
| Total Study Population All patients received both treatments | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Total Study Population |
|---|---|
| Age, Continuous | 60.3 years STANDARD_DEVIATION 10.9 |
| Body Mass Index (kg/m^2) | 32.1 kg/m2 STANDARD_DEVIATION 6.6 |
| Lipid Drugs Both statin and ezetimibe | 1 Participants |
| Lipid Drugs Neither statin nor ezetimibe | 53 Participants |
| Lipid Drugs Statin only | 46 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 97 Participants |
| Region of Enrollment United States | 100 participants |
| Sex: Female, Male Female | 57 Participants |
| Sex: Female, Male Male | 43 Participants |
| Triglyceride stratification >= 2.26 - 5.64 mmol/l (200-499 mg/dL) | 59 Participants |
| Triglyceride stratification < 2.26 mmol/L (< 200 mg/dL) | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 97 | 0 / 100 |
| other Total, other adverse events | 43 / 97 | 28 / 100 |
| serious Total, serious adverse events | 0 / 97 | 0 / 100 |
Outcome results
Primary
Percent Change in Plasma Triglycerides (Pharmacodynamic Population)
Percent change in triglycerides from baseline to end of treatment in the pharmacodynamic population
Time frame: baseline to 28 days
Population: All patients with measurable results who received both drugs
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Omega-3 Pentaenoic Acid (MAT9001) | Percent Change in Plasma Triglycerides (Pharmacodynamic Population) | -20.9 Percent Change from baseline |
| Icosapent Ethyl (Vascepa) | Percent Change in Plasma Triglycerides (Pharmacodynamic Population) | -18.3 Percent Change from baseline |
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
Time frame: Baseline to 28 days
Population: Pharmacodynamic population - all patients with measurable values who received both drugs
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Omega-3 Pentaenoic Acid (MAT9001) | Percent Change From Baseline in Omega-3 Fatty Acid Concentrations (Pharmacodynamic Population) | Eicosapentaenoic acid (EPA) | 848 Percent Change from baseline |
| Omega-3 Pentaenoic Acid (MAT9001) | Percent Change From Baseline in Omega-3 Fatty Acid Concentrations (Pharmacodynamic Population) | Docosapentaenoic acid (DPA) | 177 Percent Change from baseline |
| Omega-3 Pentaenoic Acid (MAT9001) | Percent Change From Baseline in Omega-3 Fatty Acid Concentrations (Pharmacodynamic Population) | Docosahexaenoic acid (DHA) | 1.7 Percent Change from baseline |
| Omega-3 Pentaenoic Acid (MAT9001) | Percent Change From Baseline in Omega-3 Fatty Acid Concentrations (Pharmacodynamic Population) | EPA + DHA + DPA | 205 Percent Change from baseline |
| Icosapent Ethyl (Vascepa) | Percent Change From Baseline in Omega-3 Fatty Acid Concentrations (Pharmacodynamic Population) | Docosahexaenoic acid (DHA) | -3.3 Percent Change from baseline |
| Icosapent Ethyl (Vascepa) | Percent Change From Baseline in Omega-3 Fatty Acid Concentrations (Pharmacodynamic Population) | Eicosapentaenoic acid (EPA) | 692 Percent Change from baseline |
| Icosapent Ethyl (Vascepa) | Percent Change From Baseline in Omega-3 Fatty Acid Concentrations (Pharmacodynamic Population) | EPA + DHA + DPA | 165 Percent Change from baseline |
| Icosapent Ethyl (Vascepa) | Percent Change From Baseline in Omega-3 Fatty Acid Concentrations (Pharmacodynamic Population) | Docosapentaenoic acid (DPA) | 140 Percent Change from baseline |
Secondary
Percent Change in Lipoprotein Lipids (Per Protocol Population)
Percent change from baseline in lipoprotein lipids in the per protocol population
Time frame: baseline to 28 days
Population: All patients who had measurable values for both treatments and had at least 80% compliance with study medication
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Omega-3 Pentaenoic Acid (MAT9001) | Percent Change in Lipoprotein Lipids (Per Protocol Population) | HDL-Cholesterol | -2.4 Percent Change from baseline |
| Omega-3 Pentaenoic Acid (MAT9001) | Percent Change in Lipoprotein Lipids (Per Protocol Population) | Non-HDL-Cholesterol | -6.9 Percent Change from baseline |
| Omega-3 Pentaenoic Acid (MAT9001) | Percent Change in Lipoprotein Lipids (Per Protocol Population) | LDL-Cholesterol | -4.8 Percent Change from baseline |
| Omega-3 Pentaenoic Acid (MAT9001) | Percent Change in Lipoprotein Lipids (Per Protocol Population) | Triglycerides | -20 Percent Change from baseline |
| Omega-3 Pentaenoic Acid (MAT9001) | Percent Change in Lipoprotein Lipids (Per Protocol Population) | VLDL-Cholesterol | -15 Percent Change from baseline |
| Omega-3 Pentaenoic Acid (MAT9001) | Percent Change in Lipoprotein Lipids (Per Protocol Population) | Total Cholesterol | -5.7 Percent Change from baseline |
| Icosapent Ethyl (Vascepa) | Percent Change in Lipoprotein Lipids (Per Protocol Population) | VLDL-Cholesterol | -10.9 Percent Change from baseline |
| Icosapent Ethyl (Vascepa) | Percent Change in Lipoprotein Lipids (Per Protocol Population) | LDL-Cholesterol | -2.8 Percent Change from baseline |
| Icosapent Ethyl (Vascepa) | Percent Change in Lipoprotein Lipids (Per Protocol Population) | HDL-Cholesterol | -1.3 Percent Change from baseline |
| Icosapent Ethyl (Vascepa) | Percent Change in Lipoprotein Lipids (Per Protocol Population) | Total Cholesterol | -3.5 Percent Change from baseline |
| Icosapent Ethyl (Vascepa) | Percent Change in Lipoprotein Lipids (Per Protocol Population) | Non-HDL-Cholesterol | -4.4 Percent Change from baseline |
| Icosapent Ethyl (Vascepa) | Percent Change in Lipoprotein Lipids (Per Protocol Population) | Triglycerides | -15.1 Percent Change from baseline |
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
Time frame: baseline to 28 days
Population: All patients with measurable results who received both drugs
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Omega-3 Pentaenoic Acid (MAT9001) | Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population) | Low density lipoprotein (LDL)-Cholesterol | -4.8 Percent Change from baseline |
| Omega-3 Pentaenoic Acid (MAT9001) | Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population) | Very low density lipoprotein (VLDL)-Cholesterol | -15.5 Percent Change from baseline |
| Omega-3 Pentaenoic Acid (MAT9001) | Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population) | High density lipoprotein (HDL)-Cholesterol | -1.7 Percent Change from baseline |
| Omega-3 Pentaenoic Acid (MAT9001) | Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population) | non-HDL-Cholesterol | -7 Percent Change from baseline |
| Omega-3 Pentaenoic Acid (MAT9001) | Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population) | Total Cholesterol | -5.6 Percent Change from baseline |
| Icosapent Ethyl (Vascepa) | Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population) | non-HDL-Cholesterol | -5.2 Percent Change from baseline |
| Icosapent Ethyl (Vascepa) | Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population) | Total Cholesterol | -4.1 Percent Change from baseline |
| Icosapent Ethyl (Vascepa) | Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population) | Low density lipoprotein (LDL)-Cholesterol | -3.1 Percent Change from baseline |
| Icosapent Ethyl (Vascepa) | Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population) | High density lipoprotein (HDL)-Cholesterol | -1.1 Percent Change from baseline |
| Icosapent Ethyl (Vascepa) | Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population) | Very low density lipoprotein (VLDL)-Cholesterol | -13.3 Percent Change from baseline |
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
Time frame: baseline to 28 days
Population: All patients with measurable values who received both therapies
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Omega-3 Pentaenoic Acid (MAT9001) | Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population) | Apo B | -3.5 Percent Change from baseline |
| Omega-3 Pentaenoic Acid (MAT9001) | Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population) | Proprotein convertase subtilisin/kexin type 9 (PCSK9) | -6.6 Percent Change from baseline |
| Omega-3 Pentaenoic Acid (MAT9001) | Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population) | Apo C3 | -12.4 Percent Change from baseline |
| Omega-3 Pentaenoic Acid (MAT9001) | Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population) | High-sensitivity C-reactive protein (hs-CRP) | -5.8 Percent Change from baseline |
| Omega-3 Pentaenoic Acid (MAT9001) | Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population) | Apolipoprotein (Apo) A1 | -4 Percent Change from baseline |
| Icosapent Ethyl (Vascepa) | Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population) | High-sensitivity C-reactive protein (hs-CRP) | 8.5 Percent Change from baseline |
| Icosapent Ethyl (Vascepa) | Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population) | Apolipoprotein (Apo) A1 | -3.1 Percent Change from baseline |
| Icosapent Ethyl (Vascepa) | Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population) | Apo B | -2.5 Percent Change from baseline |
| Icosapent Ethyl (Vascepa) | Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population) | Apo C3 | -11.1 Percent Change from baseline |
| Icosapent Ethyl (Vascepa) | Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population) | Proprotein convertase subtilisin/kexin type 9 (PCSK9) | -7.3 Percent Change from baseline |