Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL (MARINE)

March 28, 2022 updated by: Amarin Pharma Inc.

Evaluation of the Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride Levels ≥ 500 mg/dL and ≤ 2000 mg/dL

The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ 500 and ≤ 2000 mg/dL.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
229

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Amarin Investigational Site
      • Herlev, Denmark, 2730
        • Amarin Investigational Site
  • Finland
      • Oulu, Finland, FI-90014
        • Amarin Investigational Site
  • Germany
      • Dresden, Germany, 1307
        • Amarin Investigational Site
      • Giessen, Germany, 35392
        • Amarin Investigational Site
      • Magdeburg, Germany, 39120
        • Amarin Investigational Site
      • Muenchen, Germany, 80336
        • Amarin Investigational Site
      • Muenchen, Germany, 81377
        • Amarin Investigational Site
      • Nuernberg, Germany, 90402
        • Amarin Investigational Site
  • India
      • Ahmedabad, India, 380 015
        • Amarin Investigational Site
      • Bangalore, India, 560003
        • Amarin Investigational Site
      • Bangalore, India, 560010
        • Amarin Investigational Site
      • Bangalore, India, 560054
        • Amarin Investigational Site
      • Gopalapuram, India, 600086
        • Amarin Investigational Site
      • Indore, India, 452010
        • Amarin Investigational Site
      • Mysore, India, 570 020
        • Amarin Investigational Site
  • Italy
      • Genova, Italy, I-16132
        • Amarin Investigational Site
      • Palermo, Italy, 90127
        • Amarin Investigational Site
  • Mexico
      • Guadalajara, Jalisco, Mexico, 44600
        • Amarin Investigational Site
      • Mexico City, Mexico, 11650
        • Amarin Investigational Site
      • Mexico City, Mexico, 6700
        • Amarin Investigational Site
      • Monterrey Nuevo Leon, Mexico, 64460
        • Amarin Investigational Site
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Amarin Investigational Site
      • Groningen, Netherlands, 9711 SG
        • Amarin Investigational Site
      • Rotterdam, Netherlands, 3021 HC
        • Amarin Investigational Site
      • Rotterdam, Netherlands, 3045 PM
        • Amarin Investigational Site
      • Utrecht, Netherlands, 3584 CX
        • Amarin Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 121552
        • Amarin Investigational Site
      • Moscow, Russian Federation, 129090
        • Amarin Investigational Site
      • St Petersburg, Russian Federation, 198205
        • Amarin Investigational Site
      • St. Petersburg, Russian Federation, 194291
        • Amarin Investigational Site
      • St. Petersburg, Russian Federation, 197341
        • Amarin Investigational Site
  • South Africa
      • Bloemfontein, South Africa, 9301
        • Amarin Investigational Site
      • Cape Town, South Africa, 7500
        • Amarin Investigational Site
      • Johannesburg, South Africa, 2113
        • Amarin Investigational Site
      • Parktown, South Africa, 2193
        • Amarin Investigational Site
      • Pretoria, South Africa, 157
        • Amarin Investigational Site
      • Somerset West, South Africa, 7129
        • Amarin Investigational Site
  • Ukraine
      • Ivano-Frankivsk, Ukraine, 76018
        • Amarin Investigational Site
      • Kiev, Ukraine, 3680
        • Amarin Investigational Site
      • Kyiv, Ukraine, 4114
        • Amarin Investigational Site
      • Odessa, Ukraine, 65059
        • Amarin Investigational Site
  • United States
    • California
      • Sacramento, California, United States, 95823
        • Amarin Investigational Site
    • Colorado
      • Golden, Colorado, United States, 80401
        • Amarin Investigational Site
    • Florida
      • Miami, Florida, United States, 33169
        • Amarin Investigational Site
      • Miami, Florida, United States, 33183
        • Amarin Investigational Site
      • Ocala, Florida, United States, 34471
        • Amarin Investigational Site
    • Illinois
      • Addison, Illinois, United States, 27106
        • Amarin Investigational Site
      • Chicago, Illinois, United States, 60611
        • Amarin Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Amarin Investigational Site
    • Montana
      • Butte, Montana, United States, 59701
        • Amarin Investigational Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27527
        • Amarin Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Amarin Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • Amarin Investigational Site
      • Cincinnati, Ohio, United States, 45219
        • Amarin Investigational Site
      • Lyndhurst, Ohio, United States, 44124
        • Amarin Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Amarin Investigational Site
    • Texas
      • Corpus Christi, Texas, United States, 78404
        • Amarin Investigational Site
      • Houston, Texas, United States, 77030
        • Amarin Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23294
        • Amarin Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women, ages >18
  • Fasting triglyceride ≥500 mg/dL and ≤2000 mg/dL
  • Provide written informed consent and authorization for protected health information disclosure

Exclusion Criteria:

  • Women who are pregnant or lactating, or planning to become pregnant
  • Use of non-statin lipid-altering drugs which cannot be stopped including fibrates, niacin, fish oil and other products containing omega-3 fatty acids or other dietary supplements with potential lipid-altering effects
  • History of pancreatitis
  • History of bariatric surgery or currently on weight loss drugs
  • Uncontrolled hypertension (BP > 160/100)
  • HIV infection or on treatment with HIV-protease inhibitors, cyclophosphamide,or isotretinoin
  • Consumption of more than 2 alcoholic beverages per day
  • History of cancers (except if been disease free for >5 years OR history was basal or squamous cell skin cancer)
  • Participation in another clinical trial involving an investigational agent in the last 30 days
  • Other parameters will be assessed at the study center to ensure eligibility for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Placebo 4 capsules/day for 12 weeks (Weeks 1-12)
EXPERIMENTAL: AMR101 (ethyl icosapentate) - 2 g/day
Drug: AMR101 (ethyl icosapentate) - 2 g/day
AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks (Weeks 1-12)
Other Names:
  • VASCEPA® (icosapent ethyl)
EXPERIMENTAL: AMR101 (ethyl icosapentate) - 4 g/day
Drug: AMR101 (ethyl icosapentate) - 4 g/day
AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12)
Other Names:
  • VASCEPA® (icosapent ethyl)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect
Time Frame: baseline and 12 weeks
Median percent change from baseline to Week 12 in fasting serum triglyceride levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day
baseline and 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels
Time Frame: baseline and 12 weeks
Median percent change from baseline to Week 12 in serum very low-density lipoprotein cholesterol levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day
baseline and 12 weeks
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels
Time Frame: baseline and 12 weeks
Median percent change from baseline to Week 12 in serum Lipoprotein-associated Phospholipase A2 levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day
baseline and 12 weeks
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Group in Apolipoprotein B Levels
Time Frame: baseline and 12 weeks
Median in percent change from baseline to Week 12 in serum Apolipoprotein B levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day
baseline and 12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels
Time Frame: baseline and 12 weeks
Median percent change from baseline to Week 12 in serum low density lipoprotein cholesterol levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day
baseline and 12 weeks
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levels
Time Frame: baseline and 12 weeks
Median percent change from baseline to Week 12 in serum non-high density lipoprotein cholesterol levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day
baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amarin Pharma Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2010

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AMR-01-01-0016
  • The MARINE Study (OTHER: Amarin Pharma Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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