Trial Outcomes & Findings for Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL) (NCT NCT01047501)
NCT ID: NCT01047501
Last Updated: 2022-04-25
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
702 participants
Primary outcome timeframe
baseline and 12 weeks
Results posted on
2022-04-25
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo: Placebo 4 capsules/day for 12 weeks
|
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
|
AMR101 (Ethyl Icosapentate) - 4 g/Day
AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
233
|
236
|
233
|
|
Overall Study
COMPLETED
|
217
|
225
|
221
|
|
Overall Study
NOT COMPLETED
|
16
|
11
|
12
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: Placebo 4 capsules/day for 12 weeks
|
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
|
AMR101 (Ethyl Icosapentate) - 4 g/Day
AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
7
|
8
|
5
|
|
Overall Study
Withdrew Consent
|
6
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
|
Overall Study
Triglycerides >800 mg/dL
|
1
|
0
|
0
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Other discontinuation
|
1
|
0
|
1
|
|
Overall Study
Investigator judgement
|
0
|
0
|
1
|
Baseline Characteristics
Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL)
Baseline characteristics by cohort
| Measure |
Placebo
n=233 Participants
Placebo: Placebo 4 capsules/day for 12 weeks
|
AMR101 (Ethyl Icosapentate) - 2 g/Day
n=236 Participants
AMR101 (ethyl icosapentate) - 2 g/day: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks
|
AMR101 (Ethyl Icosapentate) - 4 g/Day
n=233 Participants
AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
|
Total
n=702 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.2 years
STANDARD_DEVIATION 10.05 • n=99 Participants
|
61.8 years
STANDARD_DEVIATION 9.42 • n=107 Participants
|
61.1 years
STANDARD_DEVIATION 10.03 • n=206 Participants
|
61.4 years
STANDARD_DEVIATION 9.83 • n=7 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
271 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
145 Participants
n=99 Participants
|
144 Participants
n=107 Participants
|
142 Participants
n=206 Participants
|
431 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
224 participants
n=99 Participants
|
226 participants
n=107 Participants
|
226 participants
n=206 Participants
|
676 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 participants
n=99 Participants
|
10 participants
n=107 Participants
|
7 participants
n=206 Participants
|
26 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: baseline and 12 weeksPopulation: 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.
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
Outcome measures
| Measure |
AMR101 (Ethyl Icosapentate) - 2 g/Day
n=234 Participants
AMR101 (ethyl icosapentate) - 2 g/day: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks
|
AMR101 (Ethyl Icosapentate) - 4 g/Day
n=226 Participants
AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
|
Placebo
n=227 Participants
Placebo: Placebo 4 capsules/day for 12 weeks
|
|---|---|---|---|
|
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect
|
-5.6 Percent change from baseline
Interval -21.1 to 13.4
|
-17.5 Percent change from baseline
Interval -30.5 to 0.5
|
5.9 Percent change from baseline
Interval -13.5 to 31.3
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: 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.
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
Outcome measures
| Measure |
AMR101 (Ethyl Icosapentate) - 2 g/Day
n=233 Participants
AMR101 (ethyl icosapentate) - 2 g/day: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks
|
AMR101 (Ethyl Icosapentate) - 4 g/Day
n=225 Participants
AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
|
Placebo
n=226 Participants
Placebo: Placebo 4 capsules/day for 12 weeks
|
|---|---|---|---|
|
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels
|
2.4 Percent change from baseline
Interval -8.3 to 17.7
|
1.5 Percent change from baseline
Interval -11.6 to 15.0
|
8.8 Percent change from baseline
Interval -7.8 to 23.2
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: 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.
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
Outcome measures
| Measure |
AMR101 (Ethyl Icosapentate) - 2 g/Day
n=234 Participants
AMR101 (ethyl icosapentate) - 2 g/day: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks
|
AMR101 (Ethyl Icosapentate) - 4 g/Day
n=226 Participants
AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
|
Placebo
n=227 Participants
Placebo: Placebo 4 capsules/day for 12 weeks
|
|---|---|---|---|
|
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levels
|
2.4 Percent change from baseline
Interval -7.0 to 19.0
|
-5.0 Percent change from baseline
Interval -13.5 to 7.8
|
9.8 Percent change from baseline
Interval -3.5 to 24.1
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: 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.
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
Outcome measures
| Measure |
AMR101 (Ethyl Icosapentate) - 2 g/Day
n=233 Participants
AMR101 (ethyl icosapentate) - 2 g/day: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks
|
AMR101 (Ethyl Icosapentate) - 4 g/Day
n=225 Participants
AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
|
Placebo
n=226 Participants
Placebo: Placebo 4 capsules/day for 12 weeks
|
|---|---|---|---|
|
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels
|
1.6 Percent change from baseline
Interval -20.0 to 34.5
|
-12.1 Percent change from baseline
Interval -31.3 to 16.7
|
15.0 Percent change from baseline
Interval -10.9 to 47.8
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: 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.
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
Outcome measures
| Measure |
AMR101 (Ethyl Icosapentate) - 2 g/Day
n=224 Participants
AMR101 (ethyl icosapentate) - 2 g/day: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks
|
AMR101 (Ethyl Icosapentate) - 4 g/Day
n=217 Participants
AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
|
Placebo
n=213 Participants
Placebo: Placebo 4 capsules/day for 12 weeks
|
|---|---|---|---|
|
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels
|
-1.8 Percent change from baseline
Interval -12.7 to 10.4
|
-12.8 Percent change from baseline
Interval -22.1 to -3.6
|
6.7 Percent change from baseline
Interval -6.4 to 17.6
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: 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.
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
Outcome measures
| Measure |
AMR101 (Ethyl Icosapentate) - 2 g/Day
n=227 Participants
AMR101 (ethyl icosapentate) - 2 g/day: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks
|
AMR101 (Ethyl Icosapentate) - 4 g/Day
n=217 Participants
AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
|
Placebo
n=219 Participants
Placebo: Placebo 4 capsules/day for 12 weeks
|
|---|---|---|---|
|
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Apolipoprotein B Levels
|
1.6 Percent change from baseline
Interval -6.4 to 14.3
|
-2.2 Percent change from baseline
Interval -10.2 to 6.2
|
7.1 Percent change from baseline
Interval -4.7 to 18.6
|
Adverse Events
Placebo
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
AMR101 (Ethyl Icosapentate) - 2 g/Day
Serious events: 6 serious events
Other events: 28 other events
Deaths: 0 deaths
AMR101 (Ethyl Icosapentate) - 4 g/Day
Serious events: 7 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=233 participants at risk
Placebo: Placebo 4 capsules/day for 12 weeks
|
AMR101 (Ethyl Icosapentate) - 2 g/Day
n=236 participants at risk
AMR101 (ethyl icosapentate) - 2 g/day: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks
|
AMR101 (Ethyl Icosapentate) - 4 g/Day
n=233 participants at risk
AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
|
|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.43%
1/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.42%
1/236 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.00%
0/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
|
Cardiac disorders
Myocardial infarction
|
0.86%
2/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.00%
0/236 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.00%
0/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
|
Cardiac disorders
Angina, unstable
|
0.00%
0/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.42%
1/236 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.00%
0/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.00%
0/236 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.43%
1/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
|
Cardiac disorders
Bradycardia
|
0.43%
1/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.00%
0/236 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.00%
0/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.42%
1/236 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.00%
0/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.85%
2/236 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.86%
2/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.43%
1/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.00%
0/236 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.00%
0/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.00%
0/236 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.43%
1/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
0.00%
0/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.42%
1/236 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.00%
0/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.43%
1/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.00%
0/236 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.00%
0/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.42%
1/236 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.00%
0/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.43%
1/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.00%
0/236 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.00%
0/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
|
Nervous system disorders
Subarachnoid hemorrhage
|
0.00%
0/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.42%
1/236 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.43%
1/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.43%
1/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.00%
0/236 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.00%
0/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.00%
0/236 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.43%
1/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.00%
0/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.00%
0/236 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.43%
1/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
|
Nervous system disorders
Syncope
|
0.00%
0/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.42%
1/236 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.00%
0/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.00%
0/236 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.43%
1/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
Other adverse events
| Measure |
Placebo
n=233 participants at risk
Placebo: Placebo 4 capsules/day for 12 weeks
|
AMR101 (Ethyl Icosapentate) - 2 g/Day
n=236 participants at risk
AMR101 (ethyl icosapentate) - 2 g/day: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks
|
AMR101 (Ethyl Icosapentate) - 4 g/Day
n=233 participants at risk
AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
4.3%
10/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
3.8%
9/236 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
3.4%
8/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
7/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
2.5%
6/236 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
0.43%
1/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.43%
1/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
3.4%
8/236 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
1.7%
4/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
|
Gastrointestinal disorders
Nausea
|
3.0%
7/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
2.1%
5/236 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
2.1%
5/233 • 12 weeks
Events were collected by systematic assessment at each study visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PIs are restricted in sharing data until an abstract presentation or publication of the manuscript.
- Publication restrictions are in place
Restriction type: OTHER