Trial Outcomes & Findings for Vascepa to Accelerate Lipoprotein Uptake and Elimination (NCT NCT03885661)
NCT ID: NCT03885661
Last Updated: 2021-11-11
Results Overview
The production rate of very low-density lipoprotein apolipoprotein B100 as determined by stable-isotope lipid kinetics techniques based on a primed constant infusion of deuterated leucine.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
≥ 13 weeks of observation on randomized treatment assignment
Results posted on
2021-11-11
Participant Flow
Statin treated Caucasian adults with hypertriglyceridemia
Participant milestones
| Measure |
Icosapent Ethyl
Icosapent ethyl with a total daily dose of 4 grams, as 2 x 1 gram capsules by mouth twice daily, against a statin background
Icosapent Ethyl 1000 MG \[Vascepa\]: Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate.
|
Usual Care
Statin background
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
8
|
|
Overall Study
Baseline
|
12
|
8
|
|
Overall Study
Treatment Visit (12 Week)
|
11
|
7
|
|
Overall Study
COMPLETED
|
11
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Icosapent Ethyl
Icosapent ethyl with a total daily dose of 4 grams, as 2 x 1 gram capsules by mouth twice daily, against a statin background
Icosapent Ethyl 1000 MG \[Vascepa\]: Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate.
|
Usual Care
Statin background
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Unwilling to undergo required study procedure
|
1
|
0
|
Baseline Characteristics
Vascepa to Accelerate Lipoprotein Uptake and Elimination
Baseline characteristics by cohort
| Measure |
Icosapent Ethyl
n=12 Participants
Icosapent ethyl with a total daily dose of 4 grams, as 2 x 1 gram capsules by mouth twice daily, against a statin background
Icosapent Ethyl 1000 MG \[Vascepa\]: Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate.
|
Usual Care
n=8 Participants
Statin background
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
VLDL apoB100 Production Rate
|
21.7 mg VLDL apoB100 / kg body weight per day
STANDARD_DEVIATION 10.8 • n=5 Participants
|
14.9 mg VLDL apoB100 / kg body weight per day
STANDARD_DEVIATION 3.4 • n=7 Participants
|
19.1 mg VLDL apoB100 / kg body weight per day
STANDARD_DEVIATION 9.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: ≥ 13 weeks of observation on randomized treatment assignmentPopulation: All subjects who completed the ≥ 13 week treatment phase of the study (13-18 weeks).
The production rate of very low-density lipoprotein apolipoprotein B100 as determined by stable-isotope lipid kinetics techniques based on a primed constant infusion of deuterated leucine.
Outcome measures
| Measure |
Icosapent Ethyl
n=11 Participants
Icosapent ethyl with a total daily dose of 4 grams, as 2 x 1 gram capsules by mouth twice daily, against a statin background
Icosapent Ethyl 1000 MG \[Vascepa\]: Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate.
|
Usual Care
n=7 Participants
Statin background
|
|---|---|---|
|
Change in VLDL-apoB100 Production Rate
L apoB100 Production Rate (Baseline)
|
21.7 mg VLDL apoB100 / kg body weight per day
Standard Deviation 10.8
|
14.9 mg VLDL apoB100 / kg body weight per day
Standard Deviation 3.4
|
|
Change in VLDL-apoB100 Production Rate
VLDL apoB100 Production Rate (Treatment)
|
21.3 mg VLDL apoB100 / kg body weight per day
Standard Deviation 10.8
|
17.2 mg VLDL apoB100 / kg body weight per day
Standard Deviation 8.5
|
Adverse Events
Icosapent Ethyl
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Icosapent Ethyl
n=12 participants at risk
Icosapent ethyl with a total daily dose of 4 grams, as 2 x 1 gram capsules by mouth twice daily, against a statin background
Icosapent Ethyl 1000 MG \[Vascepa\]: Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate.
|
Usual Care
n=8 participants at risk
Statin background
|
|---|---|---|
|
Gastrointestinal disorders
Constipation; Dyspepsia; Nausea; Gastroenteritis
|
25.0%
3/12 • Number of events 3 • 12 weeks after subjects received their first daily dose of study drug or usual care.
Adverse events were reported during scheduled visits during and after the 12 week treatment period.
|
25.0%
2/8 • Number of events 2 • 12 weeks after subjects received their first daily dose of study drug or usual care.
Adverse events were reported during scheduled visits during and after the 12 week treatment period.
|
|
Nervous system disorders
Headache; Migrane; Dizziness
|
16.7%
2/12 • Number of events 2 • 12 weeks after subjects received their first daily dose of study drug or usual care.
Adverse events were reported during scheduled visits during and after the 12 week treatment period.
|
62.5%
5/8 • Number of events 8 • 12 weeks after subjects received their first daily dose of study drug or usual care.
Adverse events were reported during scheduled visits during and after the 12 week treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis; Itchy Throat
|
0.00%
0/12 • 12 weeks after subjects received their first daily dose of study drug or usual care.
Adverse events were reported during scheduled visits during and after the 12 week treatment period.
|
25.0%
2/8 • Number of events 3 • 12 weeks after subjects received their first daily dose of study drug or usual care.
Adverse events were reported during scheduled visits during and after the 12 week treatment period.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort; Joint pain
|
16.7%
2/12 • Number of events 2 • 12 weeks after subjects received their first daily dose of study drug or usual care.
Adverse events were reported during scheduled visits during and after the 12 week treatment period.
|
12.5%
1/8 • Number of events 1 • 12 weeks after subjects received their first daily dose of study drug or usual care.
Adverse events were reported during scheduled visits during and after the 12 week treatment period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis; Urticaria
|
16.7%
2/12 • Number of events 2 • 12 weeks after subjects received their first daily dose of study drug or usual care.
Adverse events were reported during scheduled visits during and after the 12 week treatment period.
|
0.00%
0/8 • 12 weeks after subjects received their first daily dose of study drug or usual care.
Adverse events were reported during scheduled visits during and after the 12 week treatment period.
|
|
Vascular disorders
Hematoma
|
8.3%
1/12 • Number of events 1 • 12 weeks after subjects received their first daily dose of study drug or usual care.
Adverse events were reported during scheduled visits during and after the 12 week treatment period.
|
0.00%
0/8 • 12 weeks after subjects received their first daily dose of study drug or usual care.
Adverse events were reported during scheduled visits during and after the 12 week treatment period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place