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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01047501
Acronym
ANCHOR
Enrollment
702
Registered
2010-01-13
Start date
2009-12-31
Completion date
2011-02-28
Last updated
2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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, Niaspan, ezetimibe, Zetia, ethyl-EPA, ethyl icosapentate, Crestor, Zocor, Lipitor, LDL, HDL, cholesterol, dyslipidemia, VASCEPA, icosapent ethyl

Brief 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.

Interventions

DRUGAMR101 (ethyl icosapentate) - 4 g/day

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

DRUGAMR101 (ethyl icosapentate) - 2 g/day

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

DRUGPlacebo

Placebo 4 capsules/day for 12 weeks

Sponsors

Amarin Pharma Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

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 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.

Design outcomes

Primary

MeasureTime frameDescription
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effectbaseline and 12 weeksMedian 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

Secondary

MeasureTime frameDescription
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levelsbaseline and 12 weeksMedian 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
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levelsbaseline and 12 weeksMedian 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
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levelsbaseline and 12 weeksMedian 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
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levelsbaseline and 12 weeksMedian 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
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Apolipoprotein B Levelsbaseline and 12 weeksMedian 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

Countries

United States

Participant flow

Participants by arm

ArmCount
Placebo
Placebo: Placebo 4 capsules/day for 12 weeks
233
AMR101 (Ethyl Icosapentate) - 2 g/Day
AMR101 (ethyl icosapentate) - 2 g/day: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks
236
AMR101 (Ethyl Icosapentate) - 4 g/Day
AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
233
Total702

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyAdverse Event785
Overall StudyDeath100
Overall StudyInvestigator judgement001
Overall StudyLost to Follow-up011
Overall StudyOther discontinuation101
Overall StudyTriglycerides >800 mg/dL100
Overall StudyWithdrew Consent624

Baseline characteristics

CharacteristicPlaceboAMR101 (Ethyl Icosapentate) - 2 g/DayAMR101 (Ethyl Icosapentate) - 4 g/DayTotal
Age, Continuous61.2 years
STANDARD_DEVIATION 10.05
61.8 years
STANDARD_DEVIATION 9.42
61.1 years
STANDARD_DEVIATION 10.03
61.4 years
STANDARD_DEVIATION 9.83
Race/Ethnicity, Customized
Other
9 participants10 participants7 participants26 participants
Race/Ethnicity, Customized
White
224 participants226 participants226 participants676 participants
Sex: Female, Male
Female
88 Participants92 Participants91 Participants271 Participants
Sex: Female, Male
Male
145 Participants144 Participants142 Participants431 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
25 / 23328 / 23618 / 233
serious
Total, serious adverse events
5 / 2336 / 2367 / 233

Outcome results

Primary

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

Population: 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.

ArmMeasureValue (MEDIAN)
AMR101 (Ethyl Icosapentate) - 2 g/DayDifference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect-5.6 Percent change from baseline
AMR101 (Ethyl Icosapentate) - 4 g/DayDifference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect-17.5 Percent change from baseline
PlaceboDifference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect5.9 Percent change from baseline
Comparison: A sample size of 194 was required to provide 90.6% power to detect a difference of 15% between AMR101 4 g/day and placebo in percent change from baseline in fasting TG levels, assuming an SD of 45% in TG measurements and a significance level (p value) of 0.05, and 80% power to demonstrate noninferiority (p 0.025, 1-sided) of the LDL-cholesterol response between AMR101 4 g/day and placebo with a +6% margin. To accommodate a 10% drop-out rate, recruitment was planned for 648 randomized patients.p-value: <0.000195% CI: [-26.7, -16.2]Wilcoxon rank-sum test
p-value: 0.000595% CI: [-15.7, -4.5]Wilcoxon rank-sum test
Secondary

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

Time frame: baseline and 12 weeks

Population: 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.

ArmMeasureValue (MEDIAN)
AMR101 (Ethyl Icosapentate) - 2 g/DayDifference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Apolipoprotein B Levels1.6 Percent change from baseline
AMR101 (Ethyl Icosapentate) - 4 g/DayDifference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Apolipoprotein B Levels-2.2 Percent change from baseline
PlaceboDifference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Apolipoprotein B Levels7.1 Percent change from baseline
p-value: 0.000195% CI: [-12.3, -6.1]Wilcoxon rank-sum test
p-value: 0.01795% CI: [-6.9, -0.7]Wilcoxon rank-sum test
Secondary

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

Population: 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.

ArmMeasureValue (MEDIAN)
AMR101 (Ethyl Icosapentate) - 2 g/DayDifference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels-1.8 Percent change from baseline
AMR101 (Ethyl Icosapentate) - 4 g/DayDifference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels-12.8 Percent change from baseline
PlaceboDifference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels6.7 Percent change from baseline
p-value: 0.000195% CI: [-22.2, -15.7]Wilcoxon rank-sum test
p-value: 0.000495% CI: [-11.6, -4.5]Wilcoxon rank-sum test
Secondary

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

Population: 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.

ArmMeasureValue (MEDIAN)
AMR101 (Ethyl Icosapentate) - 2 g/DayDifference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels2.4 Percent change from baseline
AMR101 (Ethyl Icosapentate) - 4 g/DayDifference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels1.5 Percent change from baseline
PlaceboDifference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels8.8 Percent change from baseline
Comparison: A sample size of 194 was required to provide 90.6% power to detect a difference of 15% between AMR101 4 g/day and placebo in percent change from baseline in fasting TG levels, assuming an SD of 45% in TG measurements and a significance level (p value) of 0.05, and 80% power to demonstrate noninferiority (p 0.025, 1-sided) of the LDL-cholesterol response between AMR101 4 g/day and placebo with a +6% margin. To accommodate a 10% drop-out rate, recruitment was planned for 648 randomized patients.p-value: 0.006795% CI: [-10.5, -1.7]Wilcoxon rank-sum test
p-value: 0.086795% CI: [-7.9, 0.5]Wilcoxon rank-sum test
Secondary

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

Population: 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.

ArmMeasureValue (MEDIAN)
AMR101 (Ethyl Icosapentate) - 2 g/DayDifference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levels2.4 Percent change from baseline
AMR101 (Ethyl Icosapentate) - 4 g/DayDifference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levels-5.0 Percent change from baseline
PlaceboDifference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levels9.8 Percent change from baseline
p-value: 0.000195% CI: [-17.2, -9.9]Wilcoxon rank-sum test
p-value: 0.01495% CI: [-9.4, -1.7]Wilcoxon rank-sum test
Secondary

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

Population: 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.

ArmMeasureValue (MEDIAN)
AMR101 (Ethyl Icosapentate) - 2 g/DayDifference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels1.6 Percent change from baseline
AMR101 (Ethyl Icosapentate) - 4 g/DayDifference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels-12.1 Percent change from baseline
PlaceboDifference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels15.0 Percent change from baseline
p-value: 0.000195% CI: [-31.9, -17]Wilcoxon rank-sum test
p-value: 0.01795% CI: [-18.3, -2.5]Wilcoxon rank-sum test

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026