Trial Outcomes & Findings for Pharmacodynamic Effects of a Free-Fatty Acid Formulation of Omega-3 Pentaenoic Acid in Adults With Hypertriglyceridemia (NCT NCT04177680)
NCT ID: NCT04177680
Last Updated: 2022-03-04
Results Overview
Percent change in triglycerides from baseline to end of treatment in the pharmacodynamic population
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
baseline to 28 days
Results posted on
2022-03-04
Participant Flow
Crossover study - each patient received both treatments
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
51
|
|
Overall Study
COMPLETED
|
47
|
48
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacodynamic Effects of a Free-Fatty Acid Formulation of Omega-3 Pentaenoic Acid in Adults With Hypertriglyceridemia
Baseline characteristics by cohort
| Measure |
Total Study Population
n=100 Participants
All patients received both treatments
|
|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
97 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=5 Participants
|
|
Body Mass Index (kg/m^2)
|
32.1 kg/m2
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Lipid Drugs
Neither statin nor ezetimibe
|
53 Participants
n=5 Participants
|
|
Lipid Drugs
Statin only
|
46 Participants
n=5 Participants
|
|
Lipid Drugs
Both statin and ezetimibe
|
1 Participants
n=5 Participants
|
|
Triglyceride stratification
< 2.26 mmol/L (< 200 mg/dL)
|
41 Participants
n=5 Participants
|
|
Triglyceride stratification
>= 2.26 - 5.64 mmol/l (200-499 mg/dL)
|
59 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 28 daysPopulation: All patients with measurable results who received both drugs
Percent change in triglycerides from baseline to end of treatment in the pharmacodynamic population
Outcome measures
| Measure |
Omega-3 Pentaenoic Acid (MAT9001)
n=94 Participants
2g MAT9001 capsules twice daily with meals
Omega 3 pentaenoic acid: Encapsulated omega-3 pentaenoic acid
|
Icosapent Ethyl (Vascepa)
n=94 Participants
2g Vascepa capsules twice daily with meals
icosapent ethyl: Encapsulated omega-3 acid ethyl esters
|
|---|---|---|
|
Percent Change in Plasma Triglycerides (Pharmacodynamic Population)
|
-20.9 Percent Change from baseline
Interval -24.6 to -17.1
|
-18.3 Percent Change from baseline
Interval -22.1 to -14.3
|
SECONDARY outcome
Timeframe: baseline to 28 daysPopulation: All patients with measurable results who received both drugs
Percent change in other lipoprotein lipids from baseline to end of treatment in the pharmacodynamic population
Outcome measures
| Measure |
Omega-3 Pentaenoic Acid (MAT9001)
n=94 Participants
2g MAT9001 capsules twice daily with meals
Omega 3 pentaenoic acid: Encapsulated omega-3 pentaenoic acid
|
Icosapent Ethyl (Vascepa)
n=94 Participants
2g Vascepa capsules twice daily with meals
icosapent ethyl: Encapsulated omega-3 acid ethyl esters
|
|---|---|---|
|
Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population)
Total Cholesterol
|
-5.6 Percent Change from baseline
Interval -7.3 to -3.8
|
-4.1 Percent Change from baseline
Interval -5.9 to -2.3
|
|
Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population)
Low density lipoprotein (LDL)-Cholesterol
|
-4.8 Percent Change from baseline
Interval -7.2 to -2.4
|
-3.1 Percent Change from baseline
Interval -5.6 to -0.6
|
|
Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population)
High density lipoprotein (HDL)-Cholesterol
|
-1.7 Percent Change from baseline
Interval -4.0 to 0.6
|
-1.1 Percent Change from baseline
Interval -3.3 to 1.2
|
|
Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population)
Very low density lipoprotein (VLDL)-Cholesterol
|
-15.5 Percent Change from baseline
Interval -18.3 to -12.5
|
-13.3 Percent Change from baseline
Interval -16.2 to -10.3
|
|
Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population)
non-HDL-Cholesterol
|
-7 Percent Change from baseline
Interval -9.1 to -4.8
|
-5.2 Percent Change from baseline
Interval -7.4 to -3.0
|
SECONDARY outcome
Timeframe: baseline to 28 daysPopulation: All patients who had measurable values for both treatments and had at least 80% compliance with study medication
Percent change from baseline in lipoprotein lipids in the per protocol population
Outcome measures
| Measure |
Omega-3 Pentaenoic Acid (MAT9001)
n=82 Participants
2g MAT9001 capsules twice daily with meals
Omega 3 pentaenoic acid: Encapsulated omega-3 pentaenoic acid
|
Icosapent Ethyl (Vascepa)
n=82 Participants
2g Vascepa capsules twice daily with meals
icosapent ethyl: Encapsulated omega-3 acid ethyl esters
|
|---|---|---|
|
Percent Change in Lipoprotein Lipids (Per Protocol Population)
Triglycerides
|
-20 Percent Change from baseline
Interval -23.7 to -16.2
|
-15.1 Percent Change from baseline
Interval -19.0 to -11.0
|
|
Percent Change in Lipoprotein Lipids (Per Protocol Population)
Total Cholesterol
|
-5.7 Percent Change from baseline
Interval -7.4 to -3.9
|
-3.5 Percent Change from baseline
Interval -5.2 to -1.7
|
|
Percent Change in Lipoprotein Lipids (Per Protocol Population)
LDL-Cholesterol
|
-4.8 Percent Change from baseline
Interval -7.3 to -2.3
|
-2.8 Percent Change from baseline
Interval -5.3 to -0.2
|
|
Percent Change in Lipoprotein Lipids (Per Protocol Population)
HDL-Cholesterol
|
-2.4 Percent Change from baseline
Interval -4.8 to 0.0
|
-1.3 Percent Change from baseline
Interval -3.7 to 1.1
|
|
Percent Change in Lipoprotein Lipids (Per Protocol Population)
VLDL-Cholesterol
|
-15 Percent Change from baseline
Interval -17.8 to -12.1
|
-10.9 Percent Change from baseline
Interval -13.8 to -7.8
|
|
Percent Change in Lipoprotein Lipids (Per Protocol Population)
Non-HDL-Cholesterol
|
-6.9 Percent Change from baseline
Interval -9.0 to -4.7
|
-4.4 Percent Change from baseline
Interval -6.6 to -2.2
|
SECONDARY outcome
Timeframe: baseline to 28 daysPopulation: All patients with measurable values who received both therapies
The percent change from baseline in Apolipoproteins, PCSK9 and hs-CRP in the PD Population
Outcome measures
| Measure |
Omega-3 Pentaenoic Acid (MAT9001)
n=94 Participants
2g MAT9001 capsules twice daily with meals
Omega 3 pentaenoic acid: Encapsulated omega-3 pentaenoic acid
|
Icosapent Ethyl (Vascepa)
n=94 Participants
2g Vascepa capsules twice daily with meals
icosapent ethyl: Encapsulated omega-3 acid ethyl esters
|
|---|---|---|
|
Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population)
Apolipoprotein (Apo) A1
|
-4 Percent Change from baseline
Interval -5.6 to -2.3
|
-3.1 Percent Change from baseline
Interval -4.7 to -1.5
|
|
Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population)
Apo B
|
-3.5 Percent Change from baseline
Interval -5.9 to -1.1
|
-2.5 Percent Change from baseline
Interval -4.9 to -0.2
|
|
Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population)
Apo C3
|
-12.4 Percent Change from baseline
Interval -15.8 to -9.0
|
-11.1 Percent Change from baseline
Interval -14.4 to -7.7
|
|
Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population)
Proprotein convertase subtilisin/kexin type 9 (PCSK9)
|
-6.6 Percent Change from baseline
Interval -10.9 to -2.1
|
-7.3 Percent Change from baseline
Interval -11.5 to -2.9
|
|
Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population)
High-sensitivity C-reactive protein (hs-CRP)
|
-5.8 Percent Change from baseline
Interval -15.3 to 4.7
|
8.5 Percent Change from baseline
Interval -2.4 to 20.7
|
SECONDARY outcome
Timeframe: Baseline to 28 daysPopulation: Pharmacodynamic population - all patients with measurable values who received both drugs
The percent change from baseline in Omega-3 fatty acid concentrations in the Pharmacodynamic population
Outcome measures
| Measure |
Omega-3 Pentaenoic Acid (MAT9001)
n=94 Participants
2g MAT9001 capsules twice daily with meals
Omega 3 pentaenoic acid: Encapsulated omega-3 pentaenoic acid
|
Icosapent Ethyl (Vascepa)
n=94 Participants
2g Vascepa capsules twice daily with meals
icosapent ethyl: Encapsulated omega-3 acid ethyl esters
|
|---|---|---|
|
Percent Change From Baseline in Omega-3 Fatty Acid Concentrations (Pharmacodynamic Population)
Eicosapentaenoic acid (EPA)
|
848 Percent Change from baseline
Interval 754.0 to 952.0
|
692 Percent Change from baseline
Interval 614.0 to 778.0
|
|
Percent Change From Baseline in Omega-3 Fatty Acid Concentrations (Pharmacodynamic Population)
Docosahexaenoic acid (DHA)
|
1.7 Percent Change from baseline
Interval -2.0 to 5.5
|
-3.3 Percent Change from baseline
Interval -6.8 to 0.2
|
|
Percent Change From Baseline in Omega-3 Fatty Acid Concentrations (Pharmacodynamic Population)
Docosapentaenoic acid (DPA)
|
177 Percent Change from baseline
Interval 160.0 to 194.0
|
140 Percent Change from baseline
Interval 126.0 to 155.0
|
|
Percent Change From Baseline in Omega-3 Fatty Acid Concentrations (Pharmacodynamic Population)
EPA + DHA + DPA
|
205 Percent Change from baseline
Interval 187.0 to 225.0
|
165 Percent Change from baseline
Interval 149.0 to 182.0
|
Adverse Events
Omega-3 Pentaenoic Acid (MAT9001)
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Icosapent Ethyl (Vascepa)
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Omega-3 Pentaenoic Acid (MAT9001)
n=97 participants at risk
2g MAT9001 capsules twice daily with meals
Omega 3 pentaenoic acid: Encapsulated omega-3 pentaenoic acid
|
Icosapent Ethyl (Vascepa)
n=100 participants at risk
2g Vascepa capsules twice daily with meals
icosapent ethyl: Encapsulated omega-3 acid ethyl esters
|
|---|---|---|
|
Gastrointestinal disorders
Total GI Disorders
|
25.8%
25/97 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
11.0%
11/100 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
|
Infections and infestations
Total Infections
|
4.1%
4/97 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
2.0%
2/100 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
|
Injury, poisoning and procedural complications
Total Injury
|
5.2%
5/97 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
3.0%
3/100 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
|
Musculoskeletal and connective tissue disorders
Total Musculoskeletal Disorders
|
7.2%
7/97 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
7.0%
7/100 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
|
Nervous system disorders
Total Nervous System Disorders
|
2.1%
2/97 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
3.0%
3/100 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
|
Eye disorders
cataract
|
0.00%
0/97 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
2.0%
2/100 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
1.0%
1/97 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
2.0%
2/100 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/97 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
3.0%
3/100 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
|
Gastrointestinal disorders
Diarrhea
|
10.3%
10/97 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
4.0%
4/100 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
2.1%
2/97 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
0.00%
0/100 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
|
Gastrointestinal disorders
Eructation
|
6.2%
6/97 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
0.00%
0/100 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
|
Gastrointestinal disorders
Flatulence
|
2.1%
2/97 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
1.0%
1/100 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
|
Gastrointestinal disorders
Nausea
|
11.3%
11/97 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
0.00%
0/100 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
|
Infections and infestations
Urinary Tract infection
|
2.1%
2/97 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
0.00%
0/100 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
|
Injury, poisoning and procedural complications
Muscle strain
|
2.1%
2/97 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
0.00%
0/100 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
3/97 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
4.0%
4/100 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
|
Nervous system disorders
Dizziness
|
2.1%
2/97 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
0.00%
0/100 • Adverse events were collected over Treatment period 1 and Treatment period 2
Adverse events were noted at each study visit while under treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place