Severe HypertriglyceridemiaPhase 1ECLIPSEIVNCT02189252

An Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis

A Phase 1 study testing Epanova and Lovaza in people with Severe Hypertriglyceridemia, run by AstraZeneca at 4 sites in 2 countries.

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

This is a randomized, open-label crossover study. The primary objective of this study is to compare the relative bioavailability of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), and the ethyl esters of EPA and DHA in plasma from a single 2 g or 4 g dose of Epanova® or 4 g… Read more about this study

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Severe Hypertriglyceridemia
What is being tested?: Epanova and Lovaza
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 4 sitesin 2 countries
Study dates: Oct 2014to Jul 2015
Phase: Phase 1
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 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, ≥18 years of age;
History of serum TG concentration ≥500 mg/dL within the past 5 years;
Have at least one episode of documented hospitalization for pancreatitis due to hypertriglyceridemia in his/her lifetime;
Have no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of physical examination, ECG, medical history, and routine laboratory test results;
Willing to maintain his/her current activity level and to follow either the NCEP TLC diet with a caloric target for weight maintenance or a prescribed low-fat diet during the screening, treatment, and washout periods (Visits 1 through 6b; Weeks -4 through 12);
Willing to eat the standardized breakfast, lunch, and dinner meals and snacks before and during Visits 4b and 6b (Weeks 4 and 12);
Willing to abstain from alcohol consumption and avoid vigorous physical activity for 48 hours prior to Visits 3 through 6b (Weeks 0 through 12); and
Subject understands the study procedures and is willing and able to sign the informed consent form to participate in the study and the Health Insurance Portability and Accountability Act authorization for release of relevant protected health information to the Investigators and study personnel.

Who cannot join

An allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, fish, or any of the components of the standardized breakfast, lunch, or dinner meals or snacks (as described to them by study staff)
Poorly controlled hypertension (resting blood pressure ≥160 mmHg systolic and/or ≥100 mmHg diastolic) prior to randomization (Visit 3 [Week 0])
A history of cancer (other than basal cell carcinoma) in the last 2 years
A recent cardiovascular event (i.e., myocardial infarction, acute coronary syndrome, new onset angina, stroke, transient ischemic attack, unstable congestive heart failure requiring a change in treatment), aortic aneurysm or resection, carotid endarterectomy, or revascularization procedure within the 6 months prior to Visit 1

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

United States3 sites

Research Site
Cincinnati, Ohio
Research Site
Kansas City, Kansas
Research Site
Philadelphia, Pennsylvania

Other trials in United States

Canada1 site

Research Site
Chocoutimi, Quebec

Other trials in Canada

About this study

Official title: A Randomized, Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy, and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis

Conditions: Severe Hypertriglyceridemia
Being tested: Epanova, Lovaza
Medical subject headings: Hypertriglyceridemia

What participants receive

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

EpanovaDrug
LovazaDrug

Study groups in NCT02189252
Study group	Role	What they receive
E4:L4	Active comparator	Crossover Sequence Receives: Drug: Epanova; Drug: Lovaza
L4:E4	Active comparator	Crossover Sequence Receives: Drug: Epanova; Drug: Lovaza
E2:L4	Active comparator	Crossover Sequence Receives: Drug: Epanova; Drug: Lovaza
L4:E2	Active comparator	Crossover Sequence Receives: Drug: Epanova; Drug: Lovaza

What is being measured

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

Baseline-adjusted AUC0-24 for Plasma Total EPA + Total DHA
AUC0-24: Area under the plasma concentration versus time curve, from time 0 to 24 hours after start of the meal
Measured: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
Baseline-adjusted Cmax for Plasma Total EPA + Total DHA
Cmax: Maximum measured plasma concentration over the time span specified
Measured: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.

Secondary outcomes (6)

Baseline-adjusted AUC0-24 for Plasma Total EPA
Measured: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
Baseline-adjusted Cmax for Plasma Total EPA
Measured: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
Baseline-adjusted AUC0-24 for Plasma Total DHA
Measured: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
Baseline-adjusted Cmax for Plasma Total DHA
Measured: This is a crossover study with two treatment periods. The estimated treatment effects were based on the within-subject comparison between the two treatments, each having a 4-week duration and a 4-week wash off period in between.
Baseline-adjusted AUC0-24 for Plasma Total DPA
Measured: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
Baseline-adjusted Cmax for Plasma Total DPA
Measured: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.

Timeline

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

Oct 2014Jul 2015

First posted14 Jul 2014 (estimated)
Study startOct 2014
Primary completionJul 2015
Study completionJul 2015

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 Severe HypertriglyceridemiaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02189252
Sponsor's protocol ID: D5880C00003
Other IDs: OM-EPA-013
Acronym: ECLIPSEIV
Status last verified: May 2016
First submitted: 23 Jun 2014
Last updated: 20 Jun 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Dunbar RL, Gaudet D, Davidson M, Rensfeldt M, Yang H, Nilsson C, Kvarnstrom M, Oscarsson J. Omega-3 fatty acid exposure with a low-fat diet in patients with past hypertriglyceridemia-induced acute pancreatitis; an exploratory, randomized, open-label crossover study. Lipids Health Dis. 2020 May 30;19(1):117. doi: 10.1186/s12944-020-01295-7.
PubMed 32473640

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 Severe Hypertriglyceridemia trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy, and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis
ClinicalTrials.gov ID: NCT02189252
Acronym / sponsor ID: ECLIPSEIV / D5880C00003
Conditions: Severe Hypertriglyceridemia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Oct 2014
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 14 Jul 2014 (estimated)
Results: Posted 20 Jun 2016

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
E4:L4	Active comparator	Drug: Epanova, Drug: LovazaCrossover Sequence
L4:E4	Active comparator	Drug: Epanova, Drug: LovazaCrossover Sequence
E2:L4	Active comparator	Drug: Epanova, Drug: LovazaCrossover Sequence
L4:E2	Active comparator	Drug: Epanova, Drug: LovazaCrossover Sequence

Who may qualify

Ages: 18 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Male or female, ≥18 years of age;
History of serum TG concentration ≥500 mg/dL within the past 5 years;
Have at least one episode of documented hospitalization for pancreatitis due to hypertriglyceridemia in his/her lifetime;
Have no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of physical examination, ECG, medical history, and routine laboratory test results;
Willing to maintain his/her current activity level and to follow either the NCEP TLC diet with a caloric target for weight maintenance or a prescribed low-fat diet during the screening, treatment, and washout periods (Visits 1 through 6b; Weeks -4 through 12);

Key exclusion criteria (4 listed)

An allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, fish, or any of the components of the standardized breakfast, lunch, or dinner meals or snacks (as described to them by study staff)
Poorly controlled hypertension (resting blood pressure ≥160 mmHg systolic and/or ≥100 mmHg diastolic) prior to randomization (Visit 3 [Week 0])
A history of cancer (other than basal cell carcinoma) in the last 2 years
A recent cardiovascular event (i.e., myocardial infarction, acute coronary syndrome, new onset angina, stroke, transient ischemic attack, unstable congestive heart failure requiring a change in treatment), aortic aneurysm or resection, carotid endarterectomy, or revascularization procedure within the 6 months prior to Visit 1

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
Epanova	Drug	E2:L4, E4:L4, L4:E2, L4:E4
Lovaza	Drug	E2:L4, E4:L4, L4:E2, L4:E4

Primary outcome

Baseline-adjusted AUC0-24 for Plasma Total EPA + Total DHA
Time frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
AUC0-24: Area under the plasma concentration versus time curve, from time 0 to 24 hours after start of the meal
Baseline-adjusted Cmax for Plasma Total EPA + Total DHA
Time frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
Cmax: Maximum measured plasma concentration over the time span specified

6 secondary outcomes

Baseline-adjusted AUC0-24 for Plasma Total EPA
Time frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
Baseline-adjusted Cmax for Plasma Total EPA
Time frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
Baseline-adjusted AUC0-24 for Plasma Total DHA
Time frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
Baseline-adjusted Cmax for Plasma Total DHA
Time frame: This is a crossover study with two treatment periods. The estimated treatment effects were based on the within-subject comparison between the two treatments, each having a 4-week duration and a 4-week wash off period in between.
Baseline-adjusted AUC0-24 for Plasma Total DPA
Time frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
Baseline-adjusted Cmax for Plasma Total DPA
Time frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.

Results and safety

Results posted to the registry on 20 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence 1	4	4
Treatment Sequence 2	4	2
Treatment Sequence 3	3	3
Treatment Sequence 4	4	4

Primary outcome: Baseline-adjusted AUC0-24 for Plasma Total EPA + Total DHA

Time frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.. Geometric mean (Geometric Coefficient of Variation). Unit: hr*nmol/mL

Measure	Epanova 2 g n = 6	Epanova 4 g n = 6	Lovaza 4 g n = 12
Value	17000 (121.7)	18000 (104.6)	12500 (80.0)

Epanova 4 g vs Lovaza 4 g: Geometric mean ratio in %: 160.05 (95% CI 64.71 to 395.82), p = 0.2702, Mixed Models Analysis
Epanova 2 g vs Lovaza 4 g: Geometric mean ratio in %: 121.61 (95% CI 49.17 to 300.76), p = 0.6367, Mixed Models Analysis

Population analysed: PK population

Primary outcome: Baseline-adjusted Cmax for Plasma Total EPA + Total DHA

Measure	Epanova 2 g n = 6	Epanova 4 g n = 6	Lovaza 4 g n = 12
Value	1090 (78.6)	1200 (70.2)	712 (76.7)

Epanova 4 g vs Lovaza 4 g: Geometric mean ratio in %: 193.91 (95% CI 99.61 to 377.47), p = 0.0511, Mixed Models Analysis
Epanova 2 g vs Lovaza 4 g: Geometric mean ratio in %: 133.32 (95% CI 68.49 to 259.52), p = 0.3543, Mixed Models Analysis

Population analysed: PK population

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Epanova 2 g (I)	0 of 3 (0%)	2 of 3 (66.7%)	Not reported
Epanova 4 g (I)	0 of 4 (0%)	3 of 4 (75%)	Not reported
Lovaza 4 g (I)	0 of 8 (0%)	5 of 8 (62.5%)	Not reported
Epanova 2 g (II)	0 of 4 (0%)	3 of 4 (75%)	Not reported
Epanova 4 g (II)	0 of 2 (0%)	2 of 2 (100%)	Not reported
Lovaza 4 g (II)	0 of 7 (0%)	1 of 7 (14.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32473640Dunbar RL, Gaudet D, Davidson M, Rensfeldt M, Yang H, Nilsson C, Kvarnstrom M, Oscarsson J. Omega-3 fatty acid exposure with a low-fat diet in patients with past hypertriglyceridemia-induced acute pancreatitis; an exploratory, randomized, open-label crossover study. Lipids Health Dis. 2020 May 30;19(1):117. doi: 10.1186/s12944-020-01295-7.

Related trials for Severe Hypertriglyceridemia

RecruitingPhase 2
A Study to Assess the Safety, Tolerability and Efficacy of ION775
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RecruitingPhase 2
A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
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RecruitingPhase 3
Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis
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RecruitingPhase 1
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Active, not recruitingPhase 2
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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.

Andrea L Lawless, MD principal investigator

Biofortis, Inc Addison IL 60101

4 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Epanova and Lovaza in people with Severe Hypertriglyceridemia, run by AstraZeneca at 4 sites in 2 countries.

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 8 inclusion and 4 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 20 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 20 Jun 2016). 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?

Baseline-adjusted AUC0-24 for Plasma Total EPA + Total DHA (time frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.). The study lists 2 primary outcomes in all. 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 NCT02189252, 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 20 Jun 2016; AzTrials last refreshed its copy on 27 Oct 2026.