Trial · NCT04177680
Pharmacodynamic Effects of a Free-Fatty Acid Formulation of Omega-3 Pentaenoic Acid in Adults With Hypertriglyceridemia
NCT04177680, Phase 2, Completed, Matinas BioPharma Nanotechnologies, Inc.; results first posted 2022-03-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pharmacodynamic Effects of a Free-Fatty Acid Formulation of Omega-3 Pentaenoic Acid in Adults With Hypertriglyceridemia. Trials, record NCT04177680. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04177680
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacodynamic Effects of a Free-Fatty Acid Formulation of Omega-3 Pentaenoic Acid in Adults With Hypertriglyceridemia
- NCT number
- NCT04177680
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 100 participants, actual
- Lead sponsor
- Matinas BioPharma Nanotechnologies, Inc.
- Conditions
- Hypertriglyceridemia
- Interventions
- Omega 3 pentaenoic acid, icosapent ethyl
- First posted
- 2019-11-26
- Last updated
- 2022-03-04
- Results first posted
- 2022-03-04
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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 |
| Secondary | Percent Change in Lipoprotein Lipids (Per Protocol Population) | baseline to 28 days | Percent change from baseline in lipoprotein lipids in the per protocol population |
| Secondary | 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 |
| Secondary | 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 |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Plasma Triglycerides (Pharmacodynamic Population) | baseline to 28 days | All patients with measurable results who received both drugs | Percent Change from baseline | MEDIAN |
| SECONDARY | Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population) | baseline to 28 days | All patients with measurable results who received both drugs | Percent Change from baseline | MEDIAN |
| SECONDARY | Percent Change in Lipoprotein Lipids (Per Protocol Population) | baseline to 28 days | All patients who had measurable values for both treatments and had at least 80% compliance with study medication | Percent Change from baseline | MEDIAN |
| SECONDARY | Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population) | baseline to 28 days | All patients with measurable values who received both therapies | Percent Change from baseline | MEDIAN |
| SECONDARY | Percent Change From Baseline in Omega-3 Fatty Acid Concentrations (Pharmacodynamic Population) | Baseline to 28 days | Pharmacodynamic population - all patients with measurable values who received both drugs | Percent Change from baseline | MEDIAN |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Plasma Triglycerides (Pharmacodynamic Population) | Omega-3 Pentaenoic Acid (MAT9001) | -20.9 | Inter-Quartile Range -24.6 to -17.1 | Percent Change from baseline | |
| Percent Change in Plasma Triglycerides (Pharmacodynamic Population) | Icosapent Ethyl (Vascepa) | -18.3 | Inter-Quartile Range -22.1 to -14.3 | Percent Change from baseline | |
| Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population) | Omega-3 Pentaenoic Acid (MAT9001) | Total Cholesterol | -5.6 | Inter-Quartile Range -7.3 to -3.8 | Percent Change from baseline |
| Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population) | Icosapent Ethyl (Vascepa) | Total Cholesterol | -4.1 | Inter-Quartile Range -5.9 to -2.3 | Percent Change from baseline |
| Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population) | Omega-3 Pentaenoic Acid (MAT9001) | Low density lipoprotein (LDL)-Cholesterol | -4.8 | Inter-Quartile Range -7.2 to -2.4 | Percent Change from baseline |
| Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population) | Icosapent Ethyl (Vascepa) | Low density lipoprotein (LDL)-Cholesterol | -3.1 | Inter-Quartile Range -5.6 to -0.6 | Percent Change from baseline |
| Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population) | Omega-3 Pentaenoic Acid (MAT9001) | High density lipoprotein (HDL)-Cholesterol | -1.7 | Inter-Quartile Range -4 to 0.6 | Percent Change from baseline |
| Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population) | Icosapent Ethyl (Vascepa) | High density lipoprotein (HDL)-Cholesterol | -1.1 | Inter-Quartile Range -3.3 to 1.2 | Percent Change from baseline |
| Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population) | Omega-3 Pentaenoic Acid (MAT9001) | Very low density lipoprotein (VLDL)-Cholesterol | -15.5 | Inter-Quartile Range -18.3 to -12.5 | Percent Change from baseline |
| Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population) | Icosapent Ethyl (Vascepa) | Very low density lipoprotein (VLDL)-Cholesterol | -13.3 | Inter-Quartile Range -16.2 to -10.3 | Percent Change from baseline |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MAT9001 Then Vascepa | 49 | |
| Overall Study | STARTED | Vascepa Then MAT9001 | 51 | |
| Overall Study | COMPLETED | MAT9001 Then Vascepa | 47 | |
| Overall Study | COMPLETED | Vascepa Then MAT9001 | 48 | |
| Overall Study | NOT COMPLETED | MAT9001 Then Vascepa | 2 | |
| Overall Study | NOT COMPLETED | Vascepa Then MAT9001 | 3 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Total GI Disorders | Gastrointestinal disorders | Omega-3 Pentaenoic Acid (MAT9001) | 25 | 97 | |
| other | Total GI Disorders | Gastrointestinal disorders | Icosapent Ethyl (Vascepa) | 11 | 100 | |
| other | Total Infections | Infections and infestations | Omega-3 Pentaenoic Acid (MAT9001) | 4 | 97 | |
| other | Total Infections | Infections and infestations | Icosapent Ethyl (Vascepa) | 2 | 100 | |
| other | Total Injury | Injury, poisoning and procedural complications | Omega-3 Pentaenoic Acid (MAT9001) | 5 | 97 | |
| other | Total Injury | Injury, poisoning and procedural complications | Icosapent Ethyl (Vascepa) | 3 | 100 | |
| other | Total Musculoskeletal Disorders | Musculoskeletal and connective tissue disorders | Omega-3 Pentaenoic Acid (MAT9001) | 7 | 97 | |
| other | Total Musculoskeletal Disorders | Musculoskeletal and connective tissue disorders | Icosapent Ethyl (Vascepa) | 7 | 100 | |
| other | Total Nervous System Disorders | Nervous system disorders | Omega-3 Pentaenoic Acid (MAT9001) | 2 | 97 | |
| other | Total Nervous System Disorders | Nervous system disorders | Icosapent Ethyl (Vascepa) | 3 | 100 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Omega-3 Pentaenoic Acid (MAT9001) | 0 | 97 |
| Total, all-cause mortality | Icosapent Ethyl (Vascepa) | 0 | 100 |
| Total, other adverse events | Omega-3 Pentaenoic Acid (MAT9001) | 43 | 97 |
| Total, other adverse events | Icosapent Ethyl (Vascepa) | 28 | 100 |
| Total, serious adverse events | Omega-3 Pentaenoic Acid (MAT9001) | 0 | 97 |
| Total, serious adverse events | Icosapent Ethyl (Vascepa) | 0 | 100 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35232215 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Omega-3 Pentaenoic Acid (MAT9001) vs Icosapent Ethyl (Vascepa): deaths from any cause | Trial comparisons |
| Omega-3 Pentaenoic Acid (MAT9001) vs Icosapent Ethyl (Vascepa): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04177680
GET https://conductscience.org/api/trials/v1/NCT04177680/results?page=2