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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

229

Phase

  • 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

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
Intervention / Treatment
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

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

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

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

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

December 1, 2009

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

January 11, 2010

First Submitted That Met QC Criteria

January 12, 2010

First Posted (ESTIMATE)

January 13, 2010

Study Record Updates

Last Update Posted (ACTUAL)

April 25, 2022

Last Update Submitted That Met QC Criteria

March 28, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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