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

NCT01047683 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: AMR-01-01-0016The MARINE Study
• Study Type: interventional
• Target: 229
• Locations: 11 countries
• Sites: 60

Brief 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.

Conditions

Hypertriglyceridemia

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

Outcome Measures

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

  baseline and 12 weeks

Secondary Outcomes (3)

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

  baseline and 12 weeks

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

  baseline and 12 weeks

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

  baseline and 12 weeks

Other Outcomes (2)

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

  baseline and 12 weeks

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

  baseline and 12 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

AMR101 (ethyl icosapentate) - 2 g/day

EXPERIMENTAL

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

AMR101 (ethyl icosapentate) - 4 g/day

EXPERIMENTAL

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

Interventions

AMR101 (ethyl icosapentate) - 4 g/day DRUG

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

Also known as: VASCEPA® (icosapent ethyl)

AMR101 (ethyl icosapentate) - 4 g/day

AMR101 (ethyl icosapentate) - 2 g/day DRUG

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

Also known as: VASCEPA® (icosapent ethyl)

AMR101 (ethyl icosapentate) - 2 g/day

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amarin Pharma Inc.: lead

Study Sites (60)

Amarin Investigational Site

Sacramento, California, 95823, United States

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Amarin Investigational Site

Golden, Colorado, 80401, United States

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Amarin Investigational Site

Miami, Florida, 33169, United States

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Amarin Investigational Site

Miami, Florida, 33183, United States

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Amarin Investigational Site

Ocala, Florida, 34471, United States

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Amarin Investigational Site

Addison, Illinois, 27106, United States

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Amarin Investigational Site

Chicago, Illinois, 60611, United States

Location

Amarin Investigational Site

Louisville, Kentucky, 40213, United States

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Amarin Investigational Site

Butte, Montana, 59701, United States

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Amarin Investigational Site

Raleigh, North Carolina, 27527, United States

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Amarin Investigational Site

Winston-Salem, North Carolina, 27103, United States

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Amarin Investigational Site

Cincinnati, Ohio, 45212, United States

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Amarin Investigational Site

Cincinnati, Ohio, 45219, United States

Location

Amarin Investigational Site

Lyndhurst, Ohio, 44124, United States

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Amarin Investigational Site

Tulsa, Oklahoma, 74136, United States

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Amarin Investigational Site

Corpus Christi, Texas, 78404, United States

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Amarin Investigational Site

Houston, Texas, 77030, United States

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Amarin Investigational Site

Richmond, Virginia, 23294, United States

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Amarin Investigational Site

Aalborg, 9000, Denmark

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Amarin Investigational Site

Herlev, 2730, Denmark

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Amarin Investigational Site

Oulu, FI-90014, Finland

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Amarin Investigational Site

Dresden, 1307, Germany

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Amarin Investigational Site

Giessen, 35392, Germany

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Amarin Investigational Site

Magdeburg, 39120, Germany

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Amarin Investigational Site

München, 80336, Germany

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Amarin Investigational Site

München, 81377, Germany

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Amarin Investigational Site

Nuremberg, 90402, Germany

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Amarin Investigational Site

Ahmedabad, 380 015, India

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Amarin Investigational Site

Bangalore, 560003, India

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Amarin Investigational Site

Bangalore, 560010, India

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Amarin Investigational Site

Bangalore, 560054, India

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Amarin Investigational Site

Gopālapuram, 600086, India

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Amarin Investigational Site

Indore, 452010, India

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Amarin Investigational Site

Mysore, 570 020, India

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Amarin Investigational Site

Genova, I-16132, Italy

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Amarin Investigational Site

Palermo, 90127, Italy

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Amarin Investigational Site

Guadalajara, Jalisco, 44600, Mexico

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Amarin Investigational Site

Mexico City, 11650, Mexico

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Amarin Investigational Site

Mexico City, 6700, Mexico

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Amarin Investigational Site

Monterrey Nuevo Leon, 64460, Mexico

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Amarin Investigational Site

Amsterdam, 1105 AZ, Netherlands

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Amarin Investigational Site

Groningen, 9711 SG, Netherlands

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Amarin Investigational Site

Rotterdam, 3021 HC, Netherlands

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Amarin Investigational Site

Rotterdam, 3045 PM, Netherlands

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Amarin Investigational Site

Utrecht, 3584 CX, Netherlands

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Amarin Investigational Site

Moscow, 121552, Russia

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Amarin Investigational Site

Moscow, 129090, Russia

Location

Amarin Investigational Site

Saint Petersburg, 194291, Russia

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Amarin Investigational Site

Saint Petersburg, 197341, Russia

Location

Amarin Investigational Site

Saint Petersburg, 198205, Russia

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Amarin Investigational Site

Bloemfontein, 9301, South Africa

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Amarin Investigational Site

Cape Town, 7500, South Africa

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Amarin Investigational Site

Johannesburg, 2113, South Africa

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Amarin Investigational Site

Parktown, 2193, South Africa

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Amarin Investigational Site

Pretoria, 157, South Africa

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Amarin Investigational Site

Somerset West, 7129, South Africa

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Amarin Investigational Site

Ivano-Frankivsk, 76018, Ukraine

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Amarin Investigational Site

Kiev, 3680, Ukraine

Location

Amarin Investigational Site

Kyiv, 4114, Ukraine

Location

Amarin Investigational Site

Odesa, 65059, Ukraine

Location

Related Publications (9)

• 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.

  PMID: 21683321 RESULT

• 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.

  PMID: 23312052 RESULT

• 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.

  PMID: 23325450 RESULT

• 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.

  PMID: 23992935 RESULT

• 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.

  PMID: 25893544 RESULT

• 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.

  PMID: 27206952 RESULT

• 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.

  PMID: 27596132 RESULT

• 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.

  PMID: 27418543 RESULT

• 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.

  PMID: 27939227 RESULT

MeSH Terms

Conditions

Hypertriglyceridemia; Dyslipidemias

Interventions

eicosapentaenoic acid ethyl ester; eicosapentaenoic acid ethanolamide

Condition Hierarchy (Ancestors)

Hyperlipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Alex Giaquinto
• Organization: Amarin Pharma, Inc.

alex.giaquinto@amarincorp.com

+1 908 326 1324

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 13, 2010
• Study Start: December 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: July 1, 2011
• Last Updated: April 25, 2022
• Results First Posted: April 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6); ZA (6); NL (5); FI (1); IN (7); ME (4); DK (2); IT (2); UA (4); US (18); RU (5)