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CompletedNCT01047683MARINEUpdated Apr 25, 2022Results posted

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

A Phase 3 interventional study of AMR101 (ethyl icosapentate) - 4 g/day and AMR101 (ethyl icosapentate) - 2 g/day in Hypertriglyceridemia, sponsored by Amarin Pharma Inc.. Completed at 60 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-25.

Sponsored by Amarin Pharma Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
229
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hypertriglyceridemia

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Keywords

  • hypertriglyceridemia
  • omega-3 fatty acids
  • statin
  • triglycerides
  • lipids
  • EPA
  • docosahexaenoic acid
  • fish
  • fatty acids
  • fibrates
  • niacin
  • lipid
  • atorvastatin
  • Lovaza
  • simvastatin
  • lovastatin
  • pravastatin
  • fluvastatin
  • rosuvastatin
  • Trilipix
  • Vytorin
  • Simcor
  • ezetimibe
  • Zetia
  • ethyl-EPA
  • ethyl icosapentate
  • Crestor
  • Zocor
  • Lipitor
  • Niaspan
  • LDL
  • HDL
  • cholesterol
  • dyslipidemia
  • VASCEPA
  • icosapent ethyl
03

In context

Hypertriglyceridemia

296 studies on the registry are indexed under Hypertriglyceridemia; 39 are open to participants now.

This study's enrollment of 229 is above the median of 66 across 259 interventional studies indexed under Hypertriglyceridemia.

Browse Hypertriglyceridemia studies →

Lead sponsor

Amarin Pharma Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
229 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    AMR101 (ethyl icosapentate) - 2 g/day

    Drug: AMR101 (ethyl icosapentate) - 2 g/day

  • Experimental
    AMR101 (ethyl icosapentate) - 4 g/day

    Drug: AMR101 (ethyl icosapentate) - 4 g/day

Interventions

  • DrugAMR101 (ethyl icosapentate) - 4 g/day

    AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12)

    Also known as: VASCEPA® (icosapent ethyl)

  • DrugAMR101 (ethyl icosapentate) - 2 g/day

    AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks (Weeks 1-12)

    Also known as: VASCEPA® (icosapent ethyl)

  • DrugPlacebo

    Placebo 4 capsules/day for 12 weeks (Weeks 1-12)

06

What researchers measure

Primary outcomes

  1. Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect

    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

    Time frame: baseline and 12 weeks

Secondary outcomes

  1. Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels

    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

    Time frame: baseline and 12 weeks

  2. Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels

    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

    Time frame: baseline and 12 weeks

  3. Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Group in Apolipoprotein B Levels

    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

    Time frame: baseline and 12 weeks

Other outcomes

  1. Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels

    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

    Time frame: baseline and 12 weeks

  2. Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levels

    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

    Time frame: baseline and 12 weeks

07

Results

Posted Apr 25, 2022

Participant flow

Participant flow — Overall Study
MilestonePlaceboAMR101 (Ethyl Icosapentate) - 2 g/DayAMR101 (Ethyl Icosapentate) - 4 g/Day
Started767677
Completed717074
Not completed563
Withdrew: Adverse event310
Withdrew: Withdrew consent142
Withdrew: Lost to follow-up010
Withdrew: Triglycerides >2000 mg/dl101

Outcome measures

PrimaryDifference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect

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

Time frame:
baseline and 12 weeks
Reported as:
Median · Percent change from baseline
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect
Percent change from baselineAMR101 (Ethyl Icosapentate) - 2 g/DayAMR101 (Ethyl Icosapentate) - 4 g/DayPlacebo
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect-7.0 (-30.1 to 18.6)-26.6 (-41.1 to 0.0)9.7 (-19.2 to 42.3)
Statistical analysis
  • AMR101 (Ethyl Icosapentate) - 4 g/Day vs Placebo · Wilcoxon rank-sum test · p = <0.0001 (Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.01 for the primary endpoint.) · Median difference (final values): -33.1 · 95% CI -46.6 to -21.5Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.
  • AMR101 (Ethyl Icosapentate) - 2 g/Day vs Placebo · Wilcoxon rank-sum test · p = 0.0051 · Median difference (final values): -19.7 · 95% CI -33.3 to -5.6Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.
SecondaryDifference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels

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

Time frame:
baseline and 12 weeks
Reported as:
Median · Percent change from baseline
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels
Percent change from baselineAMR101 (Ethyl Icosapentate) - 2 g/DayAMR101 (Ethyl Icosapentate) - 4 g/DayPlacebo
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels0.0 (-22.5 to 29.2)-19.5 (-35.7 to 19.6)13.7 (-13.5 to 55.3)
Statistical analysis
  • AMR101 (Ethyl Icosapentate) - 4 g/Day vs Placebo · Wilcoxon rank-sum test · p = 0.0005 (Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05 for secondary and exploratory endpoints.) · Median difference (final values): -28.6 · 95% CI -43.4 to -13.9Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.
  • AMR101 (Ethyl Icosapentate) - 2 g/Day vs Placebo · Wilcoxon rank-sum test · p = 0.1152 · Median difference (final values): -15.3 · 95% CI -30.3 to -0.7Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.
SecondaryDifference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels

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

Time frame:
baseline and 12 weeks
Reported as:
Median · Percent change from baseline
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels
Percent change from baselineAMR101 (Ethyl Icosapentate) - 2 g/DayAMR101 (Ethyl Icosapentate) - 4 g/DayPlacebo
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels-5.1 (-17.1 to 7.1)-17.1 (-26.2 to -1.7)-2.4 (-15.9 to 13.5)
Statistical analysis
  • AMR101 (Ethyl Icosapentate) - 4 g/Day vs Placebo · Wilcoxon rank-sum test · p = 0.0006 (Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.) · Median difference (final values): -13.6 · 95% CI -20.2 to -6.3Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.
  • AMR101 (Ethyl Icosapentate) - 2 g/Day vs Placebo · Wilcoxon rank-sum test · p = 0.2367 · Median difference (final values): -5.1 · 95% CI -12.3 to 2.2Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.
SecondaryDifference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Group in Apolipoprotein B Levels

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

Time frame:
baseline and 12 weeks
Reported as:
Median · Percent change from baseline
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Group in Apolipoprotein B Levels
Percent change from baselineAMR101 (Ethyl Icosapentate) - 2 g/DayAMR101 (Ethyl Icosapentate) - 4 g/DayPlacebo
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Group in Apolipoprotein B Levels2.1 (-4.7 to 7.6)-3.8 (-11.9 to 3.8)4.3 (-4.5 to 17.5)
Statistical analysis
  • AMR101 (Ethyl Icosapentate) - 4 g/Day vs Placebo · Wilcoxon rank-sum test · p = 0.0019 (Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.) · Median difference (final values): -8.5 · 95% CI -13.5 to -3.2Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.
  • AMR101 (Ethyl Icosapentate) - 2 g/Day vs Placebo · Wilcoxon rank-sum test · p = 0.2367 · Median difference (final values): -2.6 · 95% CI -7.8 to 1.9Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.
Other pre-specifiedDifference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels

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

Time frame:
baseline and 12 weeks
Reported as:
Median · Percent change from baseline
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels
Percent change from baselineAMR101 (Ethyl Icosapentate) - 2 g/DayAMR101 (Ethyl Icosapentate) - 4 g/DayPlacebo
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels-2.5 (-9.8 to 23.5)-4.5 (-23.3 to 17.2)-3.0 (-21.3 to 23.3)
Statistical analysis
  • AMR101 (Ethyl Icosapentate) - 4 g/Day vs Placebo · Wilcoxon rank-sum test · p = 0.6768 (Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.) · Median difference (final values): -2.3 · 95% CI -12.9 to 8.1Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.
  • AMR101 (Ethyl Icosapentate) - 2 g/Day vs Placebo · Wilcoxon rank-sum test · p = 0.3022 · Median difference (final values): 5.2 · 95% CI -5.4 to 15.6Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.
Other pre-specifiedDifference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levels

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

Time frame:
baseline and 12 weeks
Reported as:
Median · Percent change from baseline
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levels
Percent change from baselineAMR101 (Ethyl Icosapentate) - 2 g/DayAMR101 (Ethyl Icosapentate) - 4 g/DayPlacebo
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levels0.0 (-9.0 to 14.1)-7.7 (-21.6 to -0.1)7.8 (-4.1 to 26.6)
Statistical analysis
  • AMR101 (Ethyl Icosapentate) - 4 g/Day vs Placebo · Wilcoxon rank-sum test · p = <0.0001 (Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.) · Median difference (final values): -17.7 · 95% CI -25.0 to -11.3Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.
  • AMR101 (Ethyl Icosapentate) - 2 g/Day vs Placebo · Wilcoxon rank-sum test · p = 0.0182 · Median difference (final values): -8.1 · 95% CI -15.1 to -1.4Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.

Adverse events

Collected over 12 weeks. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—0/76 (0%)12/76 (15.8%)
AMR101 (Ethyl Icosapentate) - 2 g/Day—1/76 (1.3%)10/76 (13.2%)
AMR101 (Ethyl Icosapentate) - 4 g/Day—1/77 (1.3%)2/77 (2.6%)
Most frequent serious events
Most frequent serious events
EventPlaceboAMR101 (Ethyl Icosapentate) - 2 g/DayAMR101 (Ethyl Icosapentate) - 4 g/Day
Non-cardiac chest painGeneral disorders0/761/760/77
Coronary artery diseaseCardiac disorders0/760/761/77
Most frequent other events
Most frequent other events
EventPlaceboAMR101 (Ethyl Icosapentate) - 2 g/DayAMR101 (Ethyl Icosapentate) - 4 g/Day
DiarrheaGastrointestinal disorders5/764/761/77
NauseaGastrointestinal disorders4/765/761/77
EructationGastrointestinal disorders3/761/760/77

Baseline characteristics

Randomized population

Age, Continuous
Age, Continuous(years)PlaceboAMR101 (Ethyl Icosapentate) - 2 g/DayAMR101 (Ethyl Icosapentate) - 4 g/DayTotal
Mean53.4 ± 8.3453.4 ± 9.3451.9 ± 10.2752.9 ± 9.34
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboAMR101 (Ethyl Icosapentate) - 2 g/DayAMR101 (Ethyl Icosapentate) - 4 g/DayTotal
Female18181854
Male585859175
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)PlaceboAMR101 (Ethyl Icosapentate) - 2 g/DayAMR101 (Ethyl Icosapentate) - 4 g/DayTotal
White686767202
Other891027
08

Study locations

60 sites
  • Amarin Investigational Site
    Sacramento, California 95823, United States
  • Amarin Investigational Site
    Golden, Colorado 80401, United States
  • Amarin Investigational Site
    Miami, Florida 33169, United States
  • Amarin Investigational Site
    Miami, Florida 33183, United States
  • Amarin Investigational Site
    Ocala, Florida 34471, United States
  • Amarin Investigational Site
    Addison, Illinois 27106, United States
  • Amarin Investigational Site
    Chicago, Illinois 60611, United States
  • Amarin Investigational Site
    Louisville, Kentucky 40213, United States
  • Amarin Investigational Site
    Butte, Montana 59701, United States
  • Amarin Investigational Site
    Raleigh, North Carolina 27527, United States
  • Amarin Investigational Site
    Winston-Salem, North Carolina 27103, United States
  • Amarin Investigational Site
    Cincinnati, Ohio 45212, United States
  • Amarin Investigational Site
    Cincinnati, Ohio 45219, United States
  • Amarin Investigational Site
    Lyndhurst, Ohio 44124, United States
  • Amarin Investigational Site
    Tulsa, Oklahoma 74136, United States
  • Amarin Investigational Site
    Corpus Christi, Texas 78404, United States
  • Amarin Investigational Site
    Houston, Texas 77030, United States
  • Amarin Investigational Site
    Richmond, Virginia 23294, United States
  • Amarin Investigational Site
    Aalborg, 9000, Denmark
  • Amarin Investigational Site
    Herlev, 2730, Denmark
  • Amarin Investigational Site
    Oulu, FI-90014, Finland
  • Amarin Investigational Site
    Dresden, 1307, Germany
  • Amarin Investigational Site
    Giessen, 35392, Germany
  • Amarin Investigational Site
    Magdeburg, 39120, Germany
  • Amarin Investigational Site
    Muenchen, 80336, Germany
  • Amarin Investigational Site
    Muenchen, 81377, Germany
  • Amarin Investigational Site
    Nuernberg, 90402, Germany
  • Amarin Investigational Site
    Ahmedabad, 380 015, India
  • Amarin Investigational Site
    Bangalore, 560003, India
  • Amarin Investigational Site
    Bangalore, 560010, India
  • Amarin Investigational Site
    Bangalore, 560054, India
  • Amarin Investigational Site
    Gopalapuram, 600086, India
  • Amarin Investigational Site
    Indore, 452010, India
  • Amarin Investigational Site
    Mysore, 570 020, India
  • Amarin Investigational Site
    Genova, I-16132, Italy
  • Amarin Investigational Site
    Palermo, 90127, Italy
  • Amarin Investigational Site
    Guadalajara, Jalisco, 44600, Mexico
  • Amarin Investigational Site
    Mexico City, 11650, Mexico
  • Amarin Investigational Site
    Mexico City, 6700, Mexico
  • Amarin Investigational Site
    Monterrey Nuevo Leon, 64460, Mexico
  • Amarin Investigational Site
    Amsterdam, 1105 AZ, Netherlands
  • Amarin Investigational Site
    Groningen, 9711 SG, Netherlands
  • Amarin Investigational Site
    Rotterdam, 3021 HC, Netherlands
  • Amarin Investigational Site
    Rotterdam, 3045 PM, Netherlands
  • Amarin Investigational Site
    Utrecht, 3584 CX, Netherlands
  • Amarin Investigational Site
    Moscow, 121552, Russian Federation
  • Amarin Investigational Site
    Moscow, 129090, Russian Federation
  • Amarin Investigational Site
    St Petersburg, 198205, Russian Federation
  • Amarin Investigational Site
    St. Petersburg, 194291, Russian Federation
  • Amarin Investigational Site
    St. Petersburg, 197341, Russian Federation
  • Amarin Investigational Site
    Bloemfontein, 9301, South Africa
  • Amarin Investigational Site
    Cape Town, 7500, South Africa
  • Amarin Investigational Site
    Johannesburg, 2113, South Africa
  • Amarin Investigational Site
    Parktown, 2193, South Africa
  • Amarin Investigational Site
    Pretoria, 157, South Africa
  • Amarin Investigational Site
    Somerset West, 7129, South Africa
  • Amarin Investigational Site
    Ivano-Frankivsk, 76018, Ukraine
  • Amarin Investigational Site
    Kiev, 3680, Ukraine
  • Amarin Investigational Site
    Kyiv, 4114, Ukraine
  • Amarin Investigational Site
    Odessa, 65059, Ukraine
09

References and documents

Publications

  • Bays HE, Ballantyne CM, Kastelein JJ, Isaacsohn JL, Braeckman RA, Soni PN. Eicosapentaenoic acid ethyl ester (AMR101) therapy in patients with very high triglyceride levels (from the Multi-center, plAcebo-controlled, Randomized, double-blINd, 12-week study with an open-label Extension [MARINE] trial). Am J Cardiol. 2011 Sep 1;108(5):682-90. doi: 10.1016/j.amjcard.2011.04.015. Epub 2011 Jun 16. PubMed 21683321 ↗
  • Bays HE, Braeckman RA, Ballantyne CM, Kastelein JJ, Otvos JD, Stirtan WG, Soni PN. Icosapent ethyl, a pure EPA omega-3 fatty acid: effects on lipoprotein particle concentration and size in patients with very high triglyceride levels (the MARINE study). J Clin Lipidol. 2012 Nov-Dec;6(6):565-72. doi: 10.1016/j.jacl.2012.07.001. Epub 2012 Jul 24. PubMed 23312052 ↗
  • Bays HE, Ballantyne CM, Braeckman RA, Stirtan WG, Soni PN. Icosapent ethyl, a pure ethyl ester of eicosapentaenoic acid: effects on circulating markers of inflammation from the MARINE and ANCHOR studies. Am J Cardiovasc Drugs. 2013 Feb;13(1):37-46. doi: 10.1007/s40256-012-0002-3. PubMed 23325450 ↗
  • Braeckman RA, Manku MS, Bays HE, Stirtan WG, Soni PN. Icosapent ethyl, a pure EPA omega-3 fatty acid: effects on plasma and red blood cell fatty acids in patients with very high triglyceride levels (results from the MARINE study). Prostaglandins Leukot Essent Fatty Acids. 2013 Sep;89(4):195-201. doi: 10.1016/j.plefa.2013.07.005. Epub 2013 Aug 1. PubMed 23992935 ↗
  • Bays HE, Ballantyne CM, Braeckman RA, Stirtan WG, Doyle RT Jr, Philip S, Soni PN, Juliano RA. Icosapent Ethyl (Eicosapentaenoic Acid Ethyl Ester): Effects Upon High-Sensitivity C-Reactive Protein and Lipid Parameters in Patients With Metabolic Syndrome. Metab Syndr Relat Disord. 2015 Aug;13(6):239-47. doi: 10.1089/met.2014.0137. Epub 2015 Apr 20. PubMed 25893544 ↗
  • Ballantyne CM, Bays HE, Braeckman RA, Philip S, Stirtan WG, Doyle RT Jr, Soni PN, Juliano RA. Icosapent ethyl (eicosapentaenoic acid ethyl ester): Effects on plasma apolipoprotein C-III levels in patients from the MARINE and ANCHOR studies. J Clin Lipidol. 2016 May-Jun;10(3):635-645.e1. doi: 10.1016/j.jacl.2016.02.008. Epub 2016 Feb 23. PubMed 27206952 ↗
  • Ballantyne CM, Bays HE, Philip S, Doyle RT Jr, Braeckman RA, Stirtan WG, Soni PN, Juliano RA. Icosapent ethyl (eicosapentaenoic acid ethyl ester): Effects on remnant-like particle cholesterol from the MARINE and ANCHOR studies. Atherosclerosis. 2016 Oct;253:81-87. doi: 10.1016/j.atherosclerosis.2016.08.005. Epub 2016 Aug 20. PubMed 27596132 ↗
  • Bays HE, Ballantyne CM, Doyle RT Jr, Juliano RA, Philip S. Icosapent ethyl: Eicosapentaenoic acid concentration and triglyceride-lowering effects across clinical studies. Prostaglandins Other Lipid Mediat. 2016 Sep;125:57-64. doi: 10.1016/j.prostaglandins.2016.07.007. Epub 2016 Jul 11. PubMed 27418543 ↗
  • Mosca L, Ballantyne CM, Bays HE, Guyton JR, Philip S, Doyle RT Jr, Juliano RA. Usefulness of Icosapent Ethyl (Eicosapentaenoic Acid Ethyl Ester) in Women to Lower Triglyceride Levels (Results from the MARINE and ANCHOR Trials). Am J Cardiol. 2017 Feb 1;119(3):397-403. doi: 10.1016/j.amjcard.2016.10.027. Epub 2016 Nov 1. PubMed 27939227 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01047683
Lead sponsor
Amarin Pharma Inc.
Responsible party
Sponsor
First posted
Jan 13, 2010
Start date
Dec 2009
Primary completion
Oct 2010
Completion
Jul 2011
Results posted
Apr 25, 2022
Last update
Apr 25, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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