HypertriglyceridemiaPhase 3ANCHORNCT01047501

Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL)

A Phase 3 study testing AMR101 (ethyl icosapentate) - 4 g/day and AMR101 (ethyl icosapentate) - 2 g/day in people with Hypertriglyceridemia, run by Amarin Pharma Inc. at 80 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering high fasting triglyceride levels in patients with high risk for cardiovascular disease and fasting triglyceride levels ≥ 200 and < 500 mg/dL. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertriglyceridemia
What is being tested?: AMR101 (ethyl icosapentate) - 4 g/day and AMR101 (ethyl icosapentate) - 2 g/day
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 702 participants
Where: 80 sitesUnited States
Study dates: Dec 2009to Feb 2011
Phase: Phase 3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women, ages >18
Fasting triglyceride ≥200 mg/dL and <500 mg/dL
LDL-C (low density lipoprotein - cholesterol) ≥40 mg/dL and <100 mg/dL
High risk for coronary heart disease
On stable dose of statin (atorvastatin, rosuvastatin or simvastatin)
Provide written informed consent and authorization for protected health information disclosure

Who cannot join

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 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

Show all 9Show fewer

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.

Trial locations and contacts

80 sites in 1 country.

City, postcode or hospital

80 sites in 1 country

United States80 sites

Amarin Investigational Site
Addison, Illinois, 60101
Amarin Investigational Site
Anaheim, California, 92801
Amarin Investigational Site
Auburn, Maine, 04210
Amarin Investigational Site
Augusta, Georgia, 30904
Amarin Investigational Site
Augusta, Georgia, 30909
Amarin Investigational Site
Aventura, Florida, 33180
Amarin Investigational Site
Baltimore, Maryland, 21209
Amarin Investigational Site
Beaver, Pennsylvania, 15009
Amarin Investigational Site
Burbank, California, 91505
Amarin Investigational Site
Butte, Montana, 59701
Amarin Investigational Site
Charlotte, North Carolina, 28277
Amarin Investigational Site
Chino, California, 91710
Amarin Investigational Site
Cincinnati, Ohio, 45212
Amarin Investigational Site
Cincinnati, Ohio, 45219
Amarin Investigational Site
Clearwater, Florida, 33756
Amarin Investigational Site
Cleveland, Ohio, 44122
Amarin Investigational Site
Concord, New Hampshire, 03301
Amarin Investigational Site
Coral Gables, Florida, 33134
Amarin Investigational Site
Dallas, Texas, 75230
Amarin Investigational Site
Durham, North Carolina, 27710
Amarin Investigational Site
Elkridge, Maryland, 21075
Amarin Investigational Site
Encinitas, California, 92024
Amarin Investigational Site
Endwell, New York, 13760
Amarin Investigational Site
Ettrick, Virginia, 23803
Amarin Investigational Site
Golden, Colorado, 80401
Amarin Investigational Site
Harleysville, Pennsylvania, 19438
Amarin Investigational Site
Hialeah, Florida, 33012
Amarin Investigational Site
Hickory, North Carolina, 28601
Amarin Investigational Site
Houston, Texas, 77030
Amarin Investigational Site
Houston, Texas, 77074
Amarin Investigational Site
Indianapolis, Indiana, 46260
Amarin Investigational Site
Irvine, California, 92618
Amarin Investigational Site
Jacksonville, Florida, 32205
Amarin Investigational Site
Jacksonville, Florida, 32223
Amarin Investigational Site
Jersey Shore, Pennsylvania, 17740
Amarin Investigational Site
Kansas City, Kansas, 66160
Amarin Investigational Site
Kettering, Ohio, 45429
Amarin Investigational Site
Lake Jackson, Texas, 77566
Amarin Investigational Site
Lansdale, Pennsylvania, 19446
Amarin Investigational Site
Los Angeles, California, 90025
Amarin Investigational Site
Los Angeles, California, 90057
Amarin Investigational Site
Louisville, Kentucky, 40213
Amarin Investigational Site
Miami, Florida, 33169
Amarin Investigational Site
Morton, Illinois, 61550
Amarin Investigational Site
Mt. Pleasant, South Carolina, 29464
Amarin Investigational Site
Munfordville, Kentucky, 42765
Amarin Investigational Site
Muscle Shoals, Alabama, 35662
Amarin Investigational Site
New Port Richey, Florida, 34652
Amarin Investigational Site
New Port Richey, Florida, 34653
Amarin Investigational Site
New Windsor, New York, 12553
Amarin Investigational Site
Newton, Kansas, 67114
Amarin Investigational Site
Norfolk, Virginia, 23502
Amarin Investigational Site
Norman, Oklahoma, 73069
Amarin Investigational Site
Olive Branch, Mississippi, 38654
Amarin Investigational Site
Orlando, Florida, 32833
Amarin Investigational Site
Philadelphia, Pennsylvania, 19114
Amarin Investigational Site
Phoenix, Arizona, 85050
Amarin Investigational Site
Port Orange, Florida, 32127
Amarin Investigational Site
Raleigh, North Carolina, 27527
Amarin Investigational Site
Rapid City, South Dakota, 57702
Amarin Investigational Site
Richmond, Virginia, 23225
Amarin Investigational Site
Richmond, Virginia, 23294
Amarin Investigational Site
San Antonio, Texas, 78224
Amarin Investigational Site
San Antonio, Texas, 78229
Amarin Investigational Site
Scottsboro, Alabama, 35768
Amarin Investigational Site
Spring Valley, California, 91978
Amarin Investigational Site
St Louis, Missouri, 63110
Amarin Investigational Site
Statesville, North Carolina, 28677
Amarin Investigational Site
Syracuse, New York, 13202
Amarin Investigational Site
Temple, Texas, 76502
Amarin Investigational Site
Troy, Michigan, 48098
Amarin Investigational Site
Tucson, Arizona, 85705
Amarin Investigational Site
Tulsa, Oklahoma, 74136
Amarin Investigational Site
Wauwatosa, Wisconsin, 53226
Amarin Investigational Site
West Palm Beach, Florida, 33401
Amarin Investigational Site
Westlake Village, California, 91361
Amarin Investigational Site
Wheat Ridge, Colorado, 80033
Amarin Investigational Site
Wichita, Kansas, 67205
Amarin Investigational Site
Wilmington, North Carolina, 28401
Amarin Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: Evaluation of the Effect of Two Doses of AMR101 (Ethyl Icosapentate) on Fasting Serum Triglyceride Levels in Patients With Persistent High Triglyceride Levels (≥ 200 mg/dL and < 500 mg/dL) Despite Statin Therapy

Conditions: Hypertriglyceridemia
Being tested: AMR101 (ethyl icosapentate) - 4 g/day, AMR101 (ethyl icosapentate) - 2 g/day, Placebo
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
Medical subject headings: Hypertriglyceridemia, Dyslipidemias

What participants receive

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

AMR101 (ethyl icosapentate) - 4 g/dayDrug
Also called VASCEPA® (icosapent ethyl)
AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
AMR101 (ethyl icosapentate) - 2 g/dayDrug
Also called VASCEPA® (icosapent ethyl)
AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks
PlaceboDrug
Placebo 4 capsules/day for 12 weeks

Study groups in NCT01047501
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
AMR101 (ethyl icosapentate) - 2 g/day	Experimental	Not described Receives: Drug: AMR101 (ethyl icosapentate) - 2 g/day
AMR101 (ethyl icosapentate) - 4 g/day	Experimental	Not described Receives: Drug: AMR101 (ethyl icosapentate) - 4 g/day

What is being measured

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

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
Measured: baseline and 12 weeks

Secondary outcomes (5)

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
Measured: baseline and 12 weeks
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
Measured: baseline and 12 weeks
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
Measured: baseline and 12 weeks
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
Measured: baseline and 12 weeks
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Apolipoprotein B Levels
Median 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
Measured: baseline and 12 weeks

Timeline

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

Dec 2009Feb 2011

First posted13 Jan 2010 (estimated)
Study startDec 2009
Primary completionFeb 2011
Study completionFeb 2011

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 (13)Papers the sponsor has linked to this study.
Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 702 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01047501
Sponsor's protocol ID: AMR-01-01-0017
Other IDs: The ANCHOR Study
Acronym: ANCHOR
Status last verified: Mar 2022
First submitted: 11 Jan 2010
Last updated: 25 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
Individual data sharing: No

Publications

Ballantyne CM, Bays HE, Kastelein JJ, Stein E, Isaacsohn JL, Braeckman RA, Soni PN. Efficacy and safety of eicosapentaenoic acid ethyl ester (AMR101) therapy in statin-treated patients with persistent high triglycerides (from the ANCHOR study). Am J Cardiol. 2012 Oct 1;110(7):984-92. doi: 10.1016/j.amjcard.2012.05.031. Epub 2012 Jul 20.
PubMed 22819432
Brinton EA, Ballantyne CM, Bays HE, Kastelein JJ, Braeckman RA, Soni PN. Effects of icosapent ethyl on lipid and inflammatory parameters in patients with diabetes mellitus-2, residual elevated triglycerides (200-500 mg/dL), and on statin therapy at LDL-C goal: the ANCHOR study. Cardiovasc Diabetol. 2013 Jul 9;12:100. doi: 10.1186/1475-2840-12-100.
PubMed 23835245
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
Ballantyne CM, Braeckman RA, Bays HE, Kastelein JJ, Otvos JD, Stirtan WG, Doyle RT Jr, Soni PN, Juliano RA. Effects of icosapent ethyl on lipoprotein particle concentration and size in statin-treated patients with persistent high triglycerides (the ANCHOR Study). J Clin Lipidol. 2015 May-Jun;9(3):377-83. doi: 10.1016/j.jacl.2014.11.009. Epub 2014 Nov 29.
PubMed 26073397
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
Brinton EA, Ballantyne CM, Guyton JR, Philip S, Doyle RT Jr, Juliano RA, Mosca L. Lipid Effects of Icosapent Ethyl in Women with Diabetes Mellitus and Persistent High Triglycerides on Statin Treatment: ANCHOR Trial Subanalysis. J Womens Health (Larchmt). 2018 Sep;27(9):1170-1176. doi: 10.1089/jwh.2017.6757. Epub 2018 Mar 27.
PubMed 29583081
Miller M, Ballantyne CM, Bays HE, Granowitz C, Doyle RT Jr, Juliano RA, Philip S. Effects of Icosapent Ethyl (Eicosapentaenoic Acid Ethyl Ester) on Atherogenic Lipid/Lipoprotein, Apolipoprotein, and Inflammatory Parameters in Patients With Elevated High-Sensitivity C-Reactive Protein (from the ANCHOR Study). Am J Cardiol. 2019 Sep 1;124(5):696-701. doi: 10.1016/j.amjcard.2019.05.057. Epub 2019 Jun 6.
PubMed 31277790
Ballantyne CM, Manku MS, Bays HE, Philip S, Granowitz C, Doyle RT Jr, Juliano RA. Icosapent Ethyl Effects on Fatty Acid Profiles in Statin-Treated Patients With High Triglycerides: The Randomized, Placebo-controlled ANCHOR Study. Cardiol Ther. 2019 Jun;8(1):79-90. doi: 10.1007/s40119-019-0131-8. Epub 2019 Feb 20.
PubMed 30788718
Vijayaraghavan K, Szerlip HM, Ballantyne CM, Bays HE, Philip S, Doyle RT Jr, Juliano RA, Granowitz C. Icosapent ethyl reduces atherogenic markers in high-risk statin-treated patients with stage 3 chronic kidney disease and high triglycerides. Postgrad Med. 2019 Aug;131(6):390-396. doi: 10.1080/00325481.2019.1643633. Epub 2019 Jul 25.
PubMed 31306043

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

Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
RecruitingPhase 2
A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
Severe Hypertriglyceridemia
Recruiting
Pemafibrate for Symptomatic ICAS RCT
Intracranial Atherosclerotic Disease (ICAD), Hypertriglyceridaemia
RecruitingPhase 2
A Study to Assess the Safety, Tolerability and Efficacy of ION775
Hypertriglyceridemia, Severe Hypertriglyceridemia

All Hypertriglyceridemia trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Effect of Two Doses of AMR101 (Ethyl Icosapentate) on Fasting Serum Triglyceride Levels in Patients With Persistent High Triglyceride Levels (≥ 200 mg/dL and < 500 mg/dL) Despite Statin Therapy
ClinicalTrials.gov ID: NCT01047501
Acronym / sponsor ID: ANCHOR / AMR-01-01-0017
Conditions: Hypertriglyceridemia
Keywords: hypertriglyceridemia, omega-3 fatty acids, statin, triglycerides, lipids, EPA, docosahexaenoic acid, fish
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 702 participants (actual)
Lead sponsor: Amarin Pharma Inc.Industry (pharma, biotech, devices)
Study start: Dec 2009
Primary completion: Feb 2011 (actual)
Study completion: Feb 2011 (actual)
First posted: 13 Jan 2010 (estimated)
Results: Posted 25 Apr 2022

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: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
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

Who may qualify

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

Key inclusion criteria (6 listed)

Men and women, ages >18
Fasting triglyceride ≥200 mg/dL and <500 mg/dL
LDL-C (low density lipoprotein - cholesterol) ≥40 mg/dL and <100 mg/dL
High risk for coronary heart disease
On stable dose of statin (atorvastatin, rosuvastatin or simvastatin)

Key exclusion criteria (9 listed)

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 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

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
AMR101 (ethyl icosapentate) - 4 g/dayAlso: VASCEPA® (icosapent ethyl)AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks	Drug	AMR101 (ethyl icosapentate) - 4 g/day
AMR101 (ethyl icosapentate) - 2 g/dayAlso: VASCEPA® (icosapent ethyl)AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks	Drug	AMR101 (ethyl icosapentate) - 2 g/day
PlaceboPlacebo 4 capsules/day for 12 weeks	Drug	Placebo

Primary outcome

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

5 secondary outcomes

Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels
Time frame: 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
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels
Time frame: 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
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Apolipoprotein B Levels
Time frame: baseline and 12 weeks

Results and safety

Results posted to the registry on 25 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	233	217
AMR101 (Ethyl Icosapentate) - 2 g/Day	236	225
AMR101 (Ethyl Icosapentate) - 4 g/Day	233	221

Primary outcome: Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect

Time frame: baseline and 12 weeks. Median (Inter-Quartile Range). Unit: Percent change from baseline

Measure	AMR101 (Ethyl Icosapentate) - 2 g/Day n = 234	AMR101 (Ethyl Icosapentate) - 4 g/Day n = 226	Placebo n = 227
Value	-5.6 (-21.1 to 13.4)	-17.5 (-30.5 to 0.5)	5.9 (-13.5 to 31.3)

AMR101 (Ethyl Icosapentate) - 4 g/Day vs Placebo: Median Difference (Final Values): -21.5 (95% CI -26.7 to -16.2), p <0.0001, Wilcoxon rank-sum test
AMR101 (Ethyl Icosapentate) - 2 g/Day vs Placebo: Median Difference (Final Values): -10.1 (95% CI -15.7 to -4.5), p = 0.0005, Wilcoxon rank-sum test

Population analysed: Intent-to-treat population: randomized patients who received \>= 1 dose of study drug and had baseline and \>= 1 postrandomization efficacy measurement. Only patients with non-missing baseline and Week 12 endpoint values were included.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	5 of 233 (2.1%)	25 of 233 (10.7%)	Not reported
AMR101 (Ethyl Icosapentate) - 2 g/Day	6 of 236 (2.5%)	28 of 236 (11.9%)	Not reported
AMR101 (Ethyl Icosapentate) - 4 g/Day	7 of 233 (3%)	18 of 233 (7.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22819432Ballantyne CM, Bays HE, Kastelein JJ, Stein E, Isaacsohn JL, Braeckman RA, Soni PN. Efficacy and safety of eicosapentaenoic acid ethyl ester (AMR101) therapy in statin-treated patients with persistent high triglycerides (from the ANCHOR study). Am J Cardiol. 2012 Oct 1;110(7):984-92. doi: 10.1016/j.amjcard.2012.05.031. Epub 2012 Jul 20.
Results publication: PubMed 23835245Brinton EA, Ballantyne CM, Bays HE, Kastelein JJ, Braeckman RA, Soni PN. Effects of icosapent ethyl on lipid and inflammatory parameters in patients with diabetes mellitus-2, residual elevated triglycerides (200-500 mg/dL), and on statin therapy at LDL-C goal: the ANCHOR study. Cardiovasc Diabetol. 2013 Jul 9;12:100. doi: 10.1186/1475-2840-12-100.
Results publication: PubMed 23325450Bays 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.
Results publication: PubMed 26073397Ballantyne CM, Braeckman RA, Bays HE, Kastelein JJ, Otvos JD, Stirtan WG, Doyle RT Jr, Soni PN, Juliano RA. Effects of icosapent ethyl on lipoprotein particle concentration and size in statin-treated patients with persistent high triglycerides (the ANCHOR Study). J Clin Lipidol. 2015 May-Jun;9(3):377-83. doi: 10.1016/j.jacl.2014.11.009. Epub 2014 Nov 29.
Results publication: PubMed 25893544Bays 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.
Results publication: PubMed 27206952Ballantyne 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.
Results publication: PubMed 27596132Ballantyne 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.
Results publication: PubMed 27418543Bays 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.
Results publication: PubMed 27939227Mosca 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.
Results publication: PubMed 29583081Brinton EA, Ballantyne CM, Guyton JR, Philip S, Doyle RT Jr, Juliano RA, Mosca L. Lipid Effects of Icosapent Ethyl in Women with Diabetes Mellitus and Persistent High Triglycerides on Statin Treatment: ANCHOR Trial Subanalysis. J Womens Health (Larchmt). 2018 Sep;27(9):1170-1176. doi: 10.1089/jwh.2017.6757. Epub 2018 Mar 27.
Results publication: PubMed 31277790Miller M, Ballantyne CM, Bays HE, Granowitz C, Doyle RT Jr, Juliano RA, Philip S. Effects of Icosapent Ethyl (Eicosapentaenoic Acid Ethyl Ester) on Atherogenic Lipid/Lipoprotein, Apolipoprotein, and Inflammatory Parameters in Patients With Elevated High-Sensitivity C-Reactive Protein (from the ANCHOR Study). Am J Cardiol. 2019 Sep 1;124(5):696-701. doi: 10.1016/j.amjcard.2019.05.057. Epub 2019 Jun 6.
Results publication: PubMed 30788718Ballantyne CM, Manku MS, Bays HE, Philip S, Granowitz C, Doyle RT Jr, Juliano RA. Icosapent Ethyl Effects on Fatty Acid Profiles in Statin-Treated Patients With High Triglycerides: The Randomized, Placebo-controlled ANCHOR Study. Cardiol Ther. 2019 Jun;8(1):79-90. doi: 10.1007/s40119-019-0131-8. Epub 2019 Feb 20.
Individual participant dataSharing planned: No

Related trials for Hypertriglyceridemia

Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
RecruitingPhase 2
A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
Severe Hypertriglyceridemia
Recruiting
Pemafibrate for Symptomatic ICAS RCT
Intracranial Atherosclerotic Disease (ICAD), Hypertriglyceridaemia
RecruitingPhase 2
A Study to Assess the Safety, Tolerability and Efficacy of ION775
Hypertriglyceridemia, Severe Hypertriglyceridemia

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.

The record lists no contact. Use the official record to reach the sponsor.

80 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AMR101 (ethyl icosapentate) - 4 g/day and AMR101 (ethyl icosapentate) - 2 g/day in people with Hypertriglyceridemia, run by Amarin Pharma Inc. at 80 sites in United States.

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 6 inclusion and 9 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 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 25 Apr 2022). 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?

Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect (time frame: baseline and 12 weeks). 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 NCT01047501, which also lists 13 linked publications.

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 25 Apr 2022.