HypertriglyceridemiaPhase 2ENHANCE-ITNCT04177680

Pharmacodynamic Effects of a Free-Fatty Acid Formulation of Omega-3 Pentaenoic Acid in Adults With Hypertriglyceridemia

A Phase 2 study testing Omega 3 pentaenoic acid and icosapent ethyl in people with Hypertriglyceridemia, run by Matinas BioPharma Nanotechnologies, Inc. at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Pharmacodynamic effects of MAT9001 compared to Vascepa in adults with hypertriglyceridemia Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertriglyceridemia
What is being tested?: Omega 3 pentaenoic acid and icosapent ethyl
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 8 sitesUnited States
Study dates: 3 Jun 2020to 18 Jan 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Matinas Investigational Site
Addison, Illinois, 60101
Matinas Investigational Site
Chicago, Illinois, 60640
Matinas Investigational site
Indianapolis, Indiana, 46260
Matinas Investigational Site
Jacksonville, Florida, 32216
Matinas Investigational site
Jupiter, Florida, 33458
Matinas Investigational site
Louisville, Kentucky, 40213
Matinas Investigational Site
Port Saint Lucie, Florida, 34952
Matinas Investigational site
Richmond, Virginia, 23294

Other trials in United States

About this study

Official title: Pharmacodynamic Effects of a Free-fatty Acid Formulation of Omega-3 Pentaenoic Acid to ENHANCE Efficacy in Adults With Hypertriglyceridemia: The ENHANCE-IT Trial

Pharmacodynamic effects of MAT9001 compared to Vascepa in adults with hypertriglyceridemia

Read the 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.

Conditions: Hypertriglyceridemia
Being tested: Omega 3 pentaenoic acid, icosapent ethyl
Medical subject headings: Hypertriglyceridemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Omega 3 pentaenoic acidDrug
Also called MAT9001
Encapsulated omega-3 pentaenoic acid
icosapent ethylDrug
Also called Vascepa
Encapsulated omega-3 acid ethyl esters

Study groups in NCT04177680
Study group	Role	What they receive
Omega-3 pentaenoic acid (MAT9001)	Experimental	2g MAT9001 capsules twice daily with meals Receives: Drug: Omega 3 pentaenoic acid
Icosapent ethyl (Vascepa)	Active comparator	2g Vascepa capsules twice daily with meals Receives: Drug: icosapent ethyl

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change in Plasma Triglycerides (Pharmacodynamic Population)
Percent change in triglycerides from baseline to end of treatment in the pharmacodynamic population
Measured: baseline to 28 days

Secondary outcomes (4)

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
Measured: baseline to 28 days
Percent Change in Lipoprotein Lipids (Per Protocol Population)
Percent change from baseline in lipoprotein lipids in the per protocol population
Measured: 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
Measured: 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
Measured: Baseline to 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jun 202018 Jan 2021

First posted26 Nov 2019
Study start3 Jun 2020
Primary completion27 Nov 2020
Study completion18 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04177680
Sponsor's protocol ID: MAT-002
Acronym: ENHANCE-IT
Status last verified: Feb 2022
First submitted: 22 Nov 2019
Last updated: 4 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 35232215

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertriglyceridemia trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacodynamic Effects of a Free-fatty Acid Formulation of Omega-3 Pentaenoic Acid to ENHANCE Efficacy in Adults With Hypertriglyceridemia: The ENHANCE-IT Trial
ClinicalTrials.gov ID: NCT04177680
Acronym / sponsor ID: ENHANCE-IT / MAT-002
Conditions: Hypertriglyceridemia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Matinas BioPharma Nanotechnologies, Inc.Industry (pharma, biotech, devices)
Collaborators: Matinas Biopharma, Inc, Midwest Biomedical Research
Study start: 3 Jun 2020 (actual)
Primary completion: 27 Nov 2020 (actual)
Study completion: 18 Jan 2021 (actual)
First posted: 26 Nov 2019 (actual)
Results: Posted 4 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Pharmacodynamic effects of MAT9001 compared to Vascepa in adults with hypertriglyceridemia

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Omega-3 pentaenoic acid (MAT9001)	Experimental	Drug: Omega 3 pentaenoic acid2g MAT9001 capsules twice daily with meals
Icosapent ethyl (Vascepa)	Active comparator	Drug: icosapent ethyl2g Vascepa capsules twice daily with meals

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Omega 3 pentaenoic acidAlso: MAT9001Encapsulated omega-3 pentaenoic acid	Drug	Omega-3 pentaenoic acid (MAT9001)
icosapent ethylAlso: VascepaEncapsulated omega-3 acid ethyl esters	Drug	Icosapent ethyl (Vascepa)

Primary outcome

Percent Change in Plasma Triglycerides (Pharmacodynamic Population)
Time frame: baseline to 28 days
Percent change in triglycerides from baseline to end of treatment in the pharmacodynamic population

4 secondary outcomes

Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population)
Time frame: baseline to 28 days
Percent Change in Lipoprotein Lipids (Per Protocol Population)
Time frame: baseline to 28 days
Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population)
Time frame: baseline to 28 days
Percent Change From Baseline in Omega-3 Fatty Acid Concentrations (Pharmacodynamic Population)
Time frame: Baseline to 28 days

Results and safety

Results posted to the registry on 4 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MAT9001 Then Vascepa	49	47
Vascepa Then MAT9001	51	48

Primary outcome: Percent Change in Plasma Triglycerides (Pharmacodynamic Population)

Time frame: baseline to 28 days. Median (Inter-Quartile Range). Unit: Percent Change from baseline

Measure	Omega-3 Pentaenoic Acid (MAT9001) n = 94	Icosapent Ethyl (Vascepa) n = 94
Value	-20.9 (-24.6 to -17.1)	-18.3 (-22.1 to -14.3)

Population analysed: All patients with measurable results who received both drugs

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected over Treatment period 1 and Treatment period 2. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Omega-3 Pentaenoic Acid (MAT9001)	0 of 97 (0%)	43 of 97 (44.3%)	0 of 97
Icosapent Ethyl (Vascepa)	0 of 100 (0%)	28 of 100 (28%)	0 of 100

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35232215Maki 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.
Individual participant dataSharing planned: No

Related trials for Hypertriglyceridemia

Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
RecruitingPhase 2
A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
Severe Hypertriglyceridemia
Recruiting
Pemafibrate for Symptomatic ICAS RCT
Intracranial Atherosclerotic Disease (ICAD), Hypertriglyceridaemia
RecruitingPhase 2
A Study to Assess the Safety, Tolerability and Efficacy of ION775
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kevin Maki study director

MB Clinical Research and Consulting

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Omega 3 pentaenoic acid and icosapent ethyl in people with Hypertriglyceridemia, run by Matinas BioPharma Nanotechnologies, Inc. at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in Plasma Triglycerides (Pharmacodynamic Population) (time frame: baseline to 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04177680, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.