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Also known as AMR101
AMR101-day · 3 trials · 2 indications
The primary outcome measure was the number of patients with a first occurrence of any component of the composite of CV death, nonfatal MI (including silent MI), nonfatal stroke, coronary revascularization, or unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization during the follow-up period.
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
| Arm | Type | Description |
|---|---|---|
| AMR101 | EXPERIMENTAL | AMR101 (icosapent ethyl) + statin therapy, daily |
| Placebo | PLACEBO_COMPARATOR | Placebo + statin therapy, daily |
| AMR101 (ethyl icosapentate) - 2 g/day | EXPERIMENTAL | - |
| AMR101 (ethyl icosapentate) - 4 g/day | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AMR101 | DRUG | Parallel Assignment |
| Placebo | DRUG | Parallel Assignment |
| Statin therapy | DRUG | Stable statin therapy (± ezetimibe) for at least 28 days before lipid qualification measurement (LDL-C \>40 mg/dL and ≤100 mg/dL) |
| AMR101 (ethyl icosapentate) - 4 g/day | DRUG | AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks |
| AMR101 (ethyl icosapentate) - 2 g/day | DRUG | AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks |
Inclusion Criteria: * Men and non-pregnant or sterile women ages 45 and older * Hypertriglyceridemia * On statin therapy for at least four weeks * Either having established cardiovascular disease or at high risk for cardiovascular disease Exclusion Criteria: * Severe heart failure * Any life-thre...
Top 4 of 19 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| United Therapeutics Corporation | UTHR | 1 | PHASE3 | Ralinepag |
| Roivant Sciences Ltd. | ROIV | 3 | PHASE3 | Mosliciguat |
| Eli Lilly and Company | LLY | 1 | PHASE3 | Lepodisiran |
| Illumina, Inc. | ILMN | 1 | PHASE1 | 18F-mFBG for administration |
AMR101-day is an investigational therapy being studied for cardiovascular diseases and hypertriglyceridemia, which means elevated triglyceride levels. It was evaluated in high-risk patients with hypertriglyceridemia who were also taking statins, and in patients with fasting triglyceride levels of 500 mg/dL or higher.
AMR101-day is being developed by Amarin Corporation plc, which trades on the Nasdaq under the ticker AMRN. The company sponsored the Phase 3 clinical program evaluating the drug in cardiovascular and hypertriglyceridemia indications.
AMR101-day has completed Phase 3 clinical development. It is an investigational small molecule and is not described as approved. Two Phase 3 trials have been completed, and no trials are currently listed as active.
AMR101-day has been studied in completed Phase 3 trials. NCT01492361 evaluated its ability to reduce cardiovascular events in 8,179 high-risk patients with hypertriglyceridemia on statin therapy. NCT01047683 enrolled 229 patients with fasting triglycerides of 500 to 2000 mg/dL, and NCT01047501 enrolled 702 patients on statins with triglycerides of 200 to under 500 mg/dL.
Yes. AMR101-day is also known as AMR101 and as AMR101 (ethyl icosapentate) at a 4 g/day dose. The AMR101-day name refers to the same ethyl icosapentate development program studied by Amarin Corporation plc in its Phase 3 trials.
Across the completed Phase 3 program, 8,179 patients were enrolled in the cardiovascular outcomes trial NCT01492361, 229 patients in NCT01047683, and 702 patients in NCT01047501. The trials were randomized, double-blind, and placebo-controlled, with a combined enrollment of 8,179 patients in the largest study.