Hyperlipidemia
Conditions
Brief summary
The purpose of this study is to explore the effects of omega-3-acid ethyl esters (TAK-085) on vascular endothelial function when administered for 8 weeks, as measured by FMD, in patients with hyperlipidemia.
Detailed description
This is a multicenter, collaborative, randomized, open-label study designed to explore the effects of administration of omega-3-acid ethyl esters (TAK-085) \[2 g (2 g PO QD) or 4 g (2 g PO BID) for 8 weeks\] on vascular endothelial function, as measured by flow-mediated dilation (FMD), in patients receiving a hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor and have concurrent hypertriglyceridemia. Considering the potential bias by factors that affect FMD between treatment groups, stratified allocation will be performed with fasting triglyceride (TG) level as a factor.
Interventions
DRUGTAK-085
TAK-085 capsules
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants with the diagnosis of hyperlipidemia and receiving instructions for lifestyle improvement 2. Participants with a fasting TG level of 150 -499 mg/dL at Visit 1 after informed consent (Day -29 to Day -1 before start of study drug administration) 3. Participants receiving a stable dose of HMG-CoA reductase inhibitor therapy continuously for at least 4 weeks before informed consent at Visit 1 (Day -29 to Day -1 before start of study drug administration) 4. Male or postmenopausal female participants 5. Participants who, in the opinion of the principal investigator or the investigator, are capable of understanding the content of the clinical research and complying with the research protocol requirements. 6. Participants who can provide written informed consent prior to the conduction of the clinical research procedures 7. Participants aged ≥20 years at the time of informed consent at Visit 1(Day -28 to Day 0 before the start of study drug administration)
Exclusion criteria
1. Participants with a history of revascularization or those have had coronary artery disease (a definitive diagnosis of myocardial infarction, angina) within 24 weeks before informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration) 2. Participants who have undergo aortic aneurysmectomy within 24 weeks prior to informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration) or those with concurrent aortic aneurysm 3. Participants who have had clinically significant hemorrhagic disorders (e.g., hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, and vitreous hemorrhage) within 24 weeks prior to informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration) or those who concurrently have the above disorders 4. Participant with a fasting FMD level of 0% measured at the start of study drug administration at Visit 2 (Day -15 to Day -1 before the start of study drug administration) 5. Participants in whom the type and dosage of HMG-CoA reductase inhibitors, antidiabetic drugs and antihypertensive drugs have been changed within 4 weeks prior to informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration) 6. Participants who have started anti dyslipidemic agents within 4 weeks prior to informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration) 7. Participants requiring a change in the dose of dyslipidemia therapeutic, antidiabetic, or antihypertensive drugs during the period between informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration) and the start of study drug administration at Visit 2 (Day -15 to Day -1 before the start of study drug administration) 8. Participants with severe hepatic dysfunction 9. Participants with severe renal dysfunction (as an indicator, CKD category ≥G3b, equivalent to an A3) 10. Participants who have been diagnosed with pancreatitis 11. Participants who have been diagnosed with lipoprotein lipase deficiency, apoprotein C-II deficiency, familial hypercholesterolemia, familial combined hyperlipidemia, or familial type III hyperlipidemia 12. Participants with concurrent Cushing's syndrome, uremia, systemic lupus erythematosus (SLE), serum dysproteinemia, or hypothyroidism 13. Participants with symptomatic Peripheral Arterial Disease (PAD) 14. Participants with concurrent hypertension of grade II or higher Note 1) Note 1: Participants with systolic blood pressure of ≥160 mm Hg or diastolic BP of ≥100 mm Hg regardless of treatment with antihypertensive drugs 15. Participants who are habitual drinkers drinking an average of over 100 mL per day (expressed in terms of quantity of alcohol) or participants with, or with a history of drug abuse or addiction Note 2) 16. Participants with a history of hypersensitivity or allergy for omega-3-acid ethyl esters- 17. Participants who smoke 18. Participants participating in other clinical studies 19. Participants who have been determined to be ineligible as subjects in the study by the principal investigator or the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow-mediated Dilation (FMD) With Fasting State at Baseline, Week 4 and Week 8 | Prior to meal at Baseline, Week 4, and Week 8 | FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage. |
| Change From Baseline in FMD With Fasting State at Week 4 and Week 8 | Prior to meal at Baseline and Week 4, and Week 8 | FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage. |
| Percent Change From Baseline in FMD With Fasting State at Baseline, Week 4 and Week 8 | Prior to meal at Baseline and Week 4, and Week 8 | FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Triglyceride (TG) Level With Fasting State at Baseline, Week 4, and Week 8 | Prior to meal at Baseline, Week 4, and Week 8 | — |
| Change From Baseline in TG Level With Fasting State at Week 4 and Week 8 | Prior to meal at Baseline and Week 4, and Week 8 | — |
| Percent Change From Baseline in TG Level With Fasting State at Week 4 and Week 8 | Prior to meal at Baseline and Week 4, and Week 8 | — |
| TG Level With 4-Hours Postprandial State at Baseline, Week 4 and Week 8 | 4-hours after meal at Baseline, Week 4, and Week 8 | — |
| Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8 | 4-hours after meal at Baseline and Week 4, and Week 8 | — |
| Percent Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8 | 4-hours after meal at Baseline and Week 4, and Week 8 | — |
| Dihomo-gamma-linolenic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Prior to meal at Baseline, Week 4 and Week 8 | Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point. |
| Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at Week 4 and Week 8 | Prior to meal at Baseline and Week 4, and Week 8 | Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Dihomo-gamma-linolenic acid at each time point. |
| Percent Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at Week 4 and Week 8 | Prior to meal at Baseline and Week 4, and Week 8 | Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Dihomo-gamma-linolenic acid at each time point. |
| Arachidonic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Prior to meal at Baseline, Week 4 and Week 8 | Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point. |
| Change From Baseline in Arachidonic Acid Concentration With Fasting State at Week 4 and Week 8 | Prior to meal at Baseline and Week 4, and Week 8 | Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Arachidonic acid at each time point. |
| Percent Change From Baseline in Arachidonic Acid Concentration With Fasting State at Week 4 and Week 8 | Prior to meal at Baseline and Week 4, and Week 8 | Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Arachidonic acid at each time point. |
| Eicosapentaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Prior to meal at Baseline, Week 4 and Week 8 | Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point. |
| Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at Week 4 and Week 8 | Prior to meal at Baseline and Week 4, and Week 8 | Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Eicosapentaenoic acid at each time point. |
| FMD With 4-Hours Postprandial State at Baseline and Week 8 | 4-hours after meal at Baseline and Week 8 | FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage. |
| Docosahexaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Prior to meal at Baseline, Week 4 and Week 8 | Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point. |
| Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at Week 4 and Week 8 | Prior to meal at Baseline and Week 4, and Week 8 | Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Docosahexaenoic acid at each time point. |
| Percent Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at Week 4 and Week 8 | Prior to meal at Baseline and Week 4, and Week 8 | Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Docosahexaenoic acid at each time point. |
| Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8 | Prior to meal at Baseline, Week 4 and Week 8 | Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. |
| Change From Baseline in EPA/AA Ratio With Fasting State at Week 4 and Week 8 | Prior to meal at Baseline and Week 4, and Week 8 | Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in EPA/AA Ratio at each time point. |
| Percent Change From Baseline in EPA/AA Ratio With Fasting State at Week 4 and Week 8 | Prior to meal at Baseline and Week 4, and Week 8 | Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in EPA/AA Ratio at each time point. |
| Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8 | Prior to meal at Baseline, Week 4 and Week 8 | Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. |
| Change From Baseline in DHA/AA Ratio With Fasting State at Week 4 and Week 8 | Prior to meal at Baseline and Week 4, and Week 8 | Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in DHA/AA ratio at each time point. |
| Percent Change From Baseline in DHA/AA Ratio With Fasting State at Week 4 and Week 8 | Prior to meal at Baseline and Week 4, and Week 8 | Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in DHA/AA ratio at each time point. |
| Number of Participants Reporting One or More Adverse Events (AEs) | Up to Week 8 | — |
| Number of Participants Reporting One or More AEs Related to Body Weight | Up to Week 8 | — |
| Number of Participants Reporting One or More AEs Related to Blood Pressure in the Sitting Position | Up to Week 8 | — |
| Number of Participants Reporting One or More AEs Related to Pulse in the Sitting Position | Up to Week 8 | — |
| Number of Participants Reporting One or More AEs Related to Laboratory Tests of Fasting Plasma Glucose | Up to Week 8 | — |
| Percent Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at Week 4 and Week 8 | Prior to meal at Baseline and Week 4, and Week 8 | Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Eicosapentaenoic acid at each time point. |
| Change From Baseline in FMD With 4-Hours Postprandial State at Week 8 | 4-hours after meal at Baseline and Week 8 | FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage. |
| Percent Change From Baseline in FMD With 4-Hours Postprandial State at Week 8 | 4-hours after meal at Baseline and Week 8 | FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 7 investigative sites in Japan, from 04 August 2016 to 19 August 2017.
Pre-assignment details
Participants with a historical diagnosis of hyperlipidemia were enrolled in one of two groups, omega-3-acid ethyl esters (TAK-085) 2 grams (g) and TAK-085 4 g treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| TAK-085 2 g A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal. | 18 |
| TAK-085 4 g A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal. | 19 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Major Protocol Deviation | 1 | 0 |
Baseline characteristics
| Characteristic | TAK-085 2 g | TAK-085 4 g | Total |
|---|---|---|---|
| Age, Continuous | 58.5 Years STANDARD_DEVIATION 11.14 | 61.5 Years STANDARD_DEVIATION 7.94 | 60.1 Years STANDARD_DEVIATION 9.61 |
| BMI | 27.12 kg/m^2 STANDARD_DEVIATION 4.097 | 27.14 kg/m^2 STANDARD_DEVIATION 3.483 | 27.13 kg/m^2 STANDARD_DEVIATION 3.74 |
| Drinking History No | 14 Participants | 17 Participants | 31 Participants |
| Drinking History Yes | 4 Participants | 2 Participants | 6 Participants |
| Duration of Dyslipidemia | 9.24 Years STANDARD_DEVIATION 5.924 | 9.51 Years STANDARD_DEVIATION 5.173 | 9.38 Years STANDARD_DEVIATION 5.474 |
| EPA/AA ratio | 0.265 Ratio STANDARD_DEVIATION 0.1156 | 0.240 Ratio STANDARD_DEVIATION 0.1551 | 0.252 Ratio STANDARD_DEVIATION 0.136 |
| Frequency of Consumption of Fish About Every 2 days | 5 Participants | 2 Participants | 7 Participants |
| Frequency of Consumption of Fish About Once or Twice per Week | 11 Participants | 12 Participants | 23 Participants |
| Frequency of Consumption of Fish Almost Every Day | 1 Participants | 1 Participants | 2 Participants |
| Frequency of Consumption of Fish Rarely | 1 Participants | 4 Participants | 5 Participants |
| Height | 158.4 Centimeters (cm) STANDARD_DEVIATION 9.08 | 162.1 Centimeters (cm) STANDARD_DEVIATION 9.21 | 160.3 Centimeters (cm) STANDARD_DEVIATION 9.21 |
| Postmenopausal Period | 9.9 Years STANDARD_DEVIATION 6.11 | 16.6 Years STANDARD_DEVIATION 5.88 | 13.1 Years STANDARD_DEVIATION 6.77 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Japan | 18 Participants | 19 Participants | 37 Participants |
| Sex: Female, Male Female | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 15 Participants |
| Smoking History Ex-Smoker | 5 Participants | 10 Participants | 15 Participants |
| Smoking History Never Smoked | 13 Participants | 9 Participants | 22 Participants |
| TG level (4 h postprandial) | 265.9 mg/dL STANDARD_DEVIATION 102.63 | 278.2 mg/dL STANDARD_DEVIATION 70.54 | 272.2 mg/dL STANDARD_DEVIATION 86.6 |
| Triglyceride (TG) level (fasting) | 176.8 Milligram (mg)/deciliter (dL) STANDARD_DEVIATION 59.18 | 194.4 Milligram (mg)/deciliter (dL) STANDARD_DEVIATION 48.57 | 185.8 Milligram (mg)/deciliter (dL) STANDARD_DEVIATION 53.96 |
| Weight | 68.34 Kilograms (kg) STANDARD_DEVIATION 13.288 | 71.94 Kilograms (kg) STANDARD_DEVIATION 14.636 | 70.19 Kilograms (kg) STANDARD_DEVIATION 13.921 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 19 |
| other Total, other adverse events | 4 / 18 | 2 / 19 |
| serious Total, serious adverse events | 0 / 18 | 0 / 19 |
Outcome results
Primary
Change From Baseline in FMD With Fasting State at Week 4 and Week 8
FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.
Time frame: Prior to meal at Baseline and Week 4, and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Change From Baseline in FMD With Fasting State at Week 4 and Week 8 | Week 4 | -1.02 Percentage of dilation | Standard Deviation 2.782 |
| TAK-085 2 g | Change From Baseline in FMD With Fasting State at Week 4 and Week 8 | Week 8 | -1.20 Percentage of dilation | Standard Deviation 3.638 |
| TAK-085 4 g | Change From Baseline in FMD With Fasting State at Week 4 and Week 8 | Week 4 | -2.71 Percentage of dilation | Standard Deviation 3.48 |
| TAK-085 4 g | Change From Baseline in FMD With Fasting State at Week 4 and Week 8 | Week 8 | -1.33 Percentage of dilation | Standard Deviation 2.754 |
Primary
Flow-mediated Dilation (FMD) With Fasting State at Baseline, Week 4 and Week 8
FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.
Time frame: Prior to meal at Baseline, Week 4, and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Flow-mediated Dilation (FMD) With Fasting State at Baseline, Week 4 and Week 8 | Baseline | 6.71 Percentage of dilation | Standard Deviation 3.466 |
| TAK-085 2 g | Flow-mediated Dilation (FMD) With Fasting State at Baseline, Week 4 and Week 8 | Week 4 | 5.85 Percentage of dilation | Standard Deviation 1.92 |
| TAK-085 2 g | Flow-mediated Dilation (FMD) With Fasting State at Baseline, Week 4 and Week 8 | Week 8 | 5.38 Percentage of dilation | Standard Deviation 2.279 |
| TAK-085 4 g | Flow-mediated Dilation (FMD) With Fasting State at Baseline, Week 4 and Week 8 | Baseline | 5.85 Percentage of dilation | Standard Deviation 3.615 |
| TAK-085 4 g | Flow-mediated Dilation (FMD) With Fasting State at Baseline, Week 4 and Week 8 | Week 4 | 3.15 Percentage of dilation | Standard Deviation 2.898 |
| TAK-085 4 g | Flow-mediated Dilation (FMD) With Fasting State at Baseline, Week 4 and Week 8 | Week 8 | 3.95 Percentage of dilation | Standard Deviation 2.244 |
Primary
Percent Change From Baseline in FMD With Fasting State at Baseline, Week 4 and Week 8
FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.
Time frame: Prior to meal at Baseline and Week 4, and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Percent Change From Baseline in FMD With Fasting State at Baseline, Week 4 and Week 8 | Week 4 | 24.01 Percent of Change | Standard Deviation 143.217 |
| TAK-085 2 g | Percent Change From Baseline in FMD With Fasting State at Baseline, Week 4 and Week 8 | Week 8 | 37.37 Percent of Change | Standard Deviation 218.483 |
| TAK-085 4 g | Percent Change From Baseline in FMD With Fasting State at Baseline, Week 4 and Week 8 | Week 4 | -36.70 Percent of Change | Standard Deviation 52.824 |
| TAK-085 4 g | Percent Change From Baseline in FMD With Fasting State at Baseline, Week 4 and Week 8 | Week 8 | -8.19 Percent of Change | Standard Deviation 52.111 |
Secondary
Arachidonic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8
Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.
Time frame: Prior to meal at Baseline, Week 4 and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Arachidonic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Baseline | 254.36 μg/mL | Standard Deviation 52.266 |
| TAK-085 2 g | Arachidonic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Week 4 | 238.69 μg/mL | Standard Deviation 65.009 |
| TAK-085 2 g | Arachidonic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Week 8 | 243.71 μg/mL | Standard Deviation 76.318 |
| TAK-085 4 g | Arachidonic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Baseline | 253.08 μg/mL | Standard Deviation 69.609 |
| TAK-085 4 g | Arachidonic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Week 4 | 217.96 μg/mL | Standard Deviation 49.583 |
| TAK-085 4 g | Arachidonic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Week 8 | 197.82 μg/mL | Standard Deviation 49.991 |
Secondary
Change From Baseline in Arachidonic Acid Concentration With Fasting State at Week 4 and Week 8
Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Arachidonic acid at each time point.
Time frame: Prior to meal at Baseline and Week 4, and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Change From Baseline in Arachidonic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 4 | -15.67 μg/mL | Standard Deviation 32.588 |
| TAK-085 2 g | Change From Baseline in Arachidonic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 8 | -10.50 μg/mL | Standard Deviation 39.241 |
| TAK-085 4 g | Change From Baseline in Arachidonic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 4 | -35.12 μg/mL | Standard Deviation 37.533 |
| TAK-085 4 g | Change From Baseline in Arachidonic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 8 | -55.26 μg/mL | Standard Deviation 36.603 |
Secondary
Change From Baseline in DHA/AA Ratio With Fasting State at Week 4 and Week 8
Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in DHA/AA ratio at each time point.
Time frame: Prior to meal at Baseline and Week 4, and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Change From Baseline in DHA/AA Ratio With Fasting State at Week 4 and Week 8 | Week 4 | 0.216 Ratio | Standard Deviation 0.1782 |
| TAK-085 2 g | Change From Baseline in DHA/AA Ratio With Fasting State at Week 4 and Week 8 | Week 8 | 0.177 Ratio | Standard Deviation 0.1512 |
| TAK-085 4 g | Change From Baseline in DHA/AA Ratio With Fasting State at Week 4 and Week 8 | Week 4 | 0.419 Ratio | Standard Deviation 0.217 |
| TAK-085 4 g | Change From Baseline in DHA/AA Ratio With Fasting State at Week 4 and Week 8 | Week 8 | 0.499 Ratio | Standard Deviation 0.3002 |
Secondary
Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at Week 4 and Week 8
Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Dihomo-gamma-linolenic acid at each time point.
Time frame: Prior to meal at Baseline and Week 4, and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 4 | -8.83 μg/mL | Standard Deviation 11.838 |
| TAK-085 2 g | Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 8 | -9.91 μg/mL | Standard Deviation 9.338 |
| TAK-085 4 g | Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 4 | -22.95 μg/mL | Standard Deviation 10.112 |
| TAK-085 4 g | Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 8 | -24.01 μg/mL | Standard Deviation 10.093 |
Secondary
Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at Week 4 and Week 8
Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Docosahexaenoic acid at each time point.
Time frame: Prior to meal at Baseline and Week 4, and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 4 | 33.74 μg/mL | Standard Deviation 42.605 |
| TAK-085 2 g | Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 8 | 26.31 μg/mL | Standard Deviation 31.103 |
| TAK-085 4 g | Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 4 | 66.77 μg/mL | Standard Deviation 41.677 |
| TAK-085 4 g | Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 8 | 62.11 μg/mL | Standard Deviation 51.694 |
Secondary
Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at Week 4 and Week 8
Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Eicosapentaenoic acid at each time point.
Time frame: Prior to meal at Baseline and Week 4, and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 4 | 62.02 μg/mL | Standard Deviation 36.43 |
| TAK-085 2 g | Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 8 | 70.98 μg/mL | Standard Deviation 32.197 |
| TAK-085 4 g | Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 4 | 136.72 μg/mL | Standard Deviation 45.047 |
| TAK-085 4 g | Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 8 | 138.13 μg/mL | Standard Deviation 53.122 |
Secondary
Change From Baseline in EPA/AA Ratio With Fasting State at Week 4 and Week 8
Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in EPA/AA Ratio at each time point.
Time frame: Prior to meal at Baseline and Week 4, and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Change From Baseline in EPA/AA Ratio With Fasting State at Week 4 and Week 8 | Week 4 | 0.299 Ratio | Standard Deviation 0.1714 |
| TAK-085 2 g | Change From Baseline in EPA/AA Ratio With Fasting State at Week 4 and Week 8 | Week 8 | 0.322 Ratio | Standard Deviation 0.1301 |
| TAK-085 4 g | Change From Baseline in EPA/AA Ratio With Fasting State at Week 4 and Week 8 | Week 4 | 0.706 Ratio | Standard Deviation 0.2874 |
| TAK-085 4 g | Change From Baseline in EPA/AA Ratio With Fasting State at Week 4 and Week 8 | Week 8 | 0.803 Ratio | Standard Deviation 0.3241 |
Secondary
Change From Baseline in FMD With 4-Hours Postprandial State at Week 8
FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.
Time frame: 4-hours after meal at Baseline and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAK-085 2 g | Change From Baseline in FMD With 4-Hours Postprandial State at Week 8 | 0.02 Percentage of dilation | Standard Deviation 1.284 |
| TAK-085 4 g | Change From Baseline in FMD With 4-Hours Postprandial State at Week 8 | 1.02 Percentage of dilation | Standard Deviation 3.519 |
Secondary
Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8
Time frame: 4-hours after meal at Baseline and Week 4, and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8 | Week 4 | -9.1 mg/dL | Standard Deviation 89.29 |
| TAK-085 2 g | Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8 | Week 8 | -34.7 mg/dL | Standard Deviation 89.4 |
| TAK-085 4 g | Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8 | Week 4 | -62.1 mg/dL | Standard Deviation 54.28 |
| TAK-085 4 g | Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8 | Week 8 | -75.9 mg/dL | Standard Deviation 57.02 |
Secondary
Change From Baseline in TG Level With Fasting State at Week 4 and Week 8
Time frame: Prior to meal at Baseline and Week 4, and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Change From Baseline in TG Level With Fasting State at Week 4 and Week 8 | Week 4 | 1.4 mg/dL | Standard Deviation 69.58 |
| TAK-085 2 g | Change From Baseline in TG Level With Fasting State at Week 4 and Week 8 | Week 8 | -23.1 mg/dL | Standard Deviation 48.4 |
| TAK-085 4 g | Change From Baseline in TG Level With Fasting State at Week 4 and Week 8 | Week 4 | -49.8 mg/dL | Standard Deviation 35.67 |
| TAK-085 4 g | Change From Baseline in TG Level With Fasting State at Week 4 and Week 8 | Week 8 | -49.4 mg/dL | Standard Deviation 46.68 |
Secondary
Dihomo-gamma-linolenic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8
Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.
Time frame: Prior to meal at Baseline, Week 4 and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Dihomo-gamma-linolenic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Baseline | 51.37 microgram (μg)/milliliter (mL) | Standard Deviation 14.761 |
| TAK-085 2 g | Dihomo-gamma-linolenic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Week 4 | 42.54 microgram (μg)/milliliter (mL) | Standard Deviation 11.493 |
| TAK-085 2 g | Dihomo-gamma-linolenic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Week 8 | 43.12 microgram (μg)/milliliter (mL) | Standard Deviation 9.06 |
| TAK-085 4 g | Dihomo-gamma-linolenic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Baseline | 57.32 microgram (μg)/milliliter (mL) | Standard Deviation 12.274 |
| TAK-085 4 g | Dihomo-gamma-linolenic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Week 4 | 34.37 microgram (μg)/milliliter (mL) | Standard Deviation 7.777 |
| TAK-085 4 g | Dihomo-gamma-linolenic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Week 8 | 33.32 microgram (μg)/milliliter (mL) | Standard Deviation 8.609 |
Secondary
Docosahexaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8
Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.
Time frame: Prior to meal at Baseline, Week 4 and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Docosahexaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Baseline | 173.30 μg/mL | Standard Deviation 51.854 |
| TAK-085 2 g | Docosahexaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Week 4 | 207.04 μg/mL | Standard Deviation 51.493 |
| TAK-085 2 g | Docosahexaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Week 8 | 201.04 μg/mL | Standard Deviation 47.958 |
| TAK-085 4 g | Docosahexaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Baseline | 145.43 μg/mL | Standard Deviation 45.037 |
| TAK-085 4 g | Docosahexaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Week 4 | 212.20 μg/mL | Standard Deviation 47.226 |
| TAK-085 4 g | Docosahexaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Week 8 | 207.53 μg/mL | Standard Deviation 48.728 |
Secondary
Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8
Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition.
Time frame: Prior to meal at Baseline, Week 4 and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8 | Baseline | 0.697 Ratio | Standard Deviation 0.2163 |
| TAK-085 2 g | Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8 | Week 4 | 0.913 Ratio | Standard Deviation 0.2874 |
| TAK-085 2 g | Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8 | Week 8 | 0.881 Ratio | Standard Deviation 0.2673 |
| TAK-085 4 g | Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8 | Baseline | 0.619 Ratio | Standard Deviation 0.2795 |
| TAK-085 4 g | Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8 | Week 4 | 1.038 Ratio | Standard Deviation 0.3726 |
| TAK-085 4 g | Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8 | Week 8 | 1.119 Ratio | Standard Deviation 0.4178 |
Secondary
Eicosapentaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8
Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.
Time frame: Prior to meal at Baseline, Week 4 and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Eicosapentaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Week 8 | 134.94 μg/mL | Standard Deviation 41.173 |
| TAK-085 2 g | Eicosapentaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Baseline | 66.04 μg/mL | Standard Deviation 29.246 |
| TAK-085 2 g | Eicosapentaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Week 4 | 128.07 μg/mL | Standard Deviation 34.223 |
| TAK-085 4 g | Eicosapentaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Baseline | 55.62 μg/mL | Standard Deviation 26.992 |
| TAK-085 4 g | Eicosapentaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Week 4 | 192.34 μg/mL | Standard Deviation 43.711 |
| TAK-085 4 g | Eicosapentaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 | Week 8 | 193.75 μg/mL | Standard Deviation 45.718 |
Secondary
Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8
Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition.
Time frame: Prior to meal at Baseline, Week 4 and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8 | Baseline | 0.265 Ratio | Standard Deviation 0.1156 |
| TAK-085 2 g | Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8 | Week 4 | 0.564 Ratio | Standard Deviation 0.199 |
| TAK-085 2 g | Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8 | Week 8 | 0.579 Ratio | Standard Deviation 0.1811 |
| TAK-085 4 g | Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8 | Baseline | 0.240 Ratio | Standard Deviation 0.1551 |
| TAK-085 4 g | Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8 | Week 8 | 1.043 Ratio | Standard Deviation 0.3881 |
| TAK-085 4 g | Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8 | Week 4 | 0.946 Ratio | Standard Deviation 0.3722 |
Secondary
FMD With 4-Hours Postprandial State at Baseline and Week 8
FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.
Time frame: 4-hours after meal at Baseline and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | FMD With 4-Hours Postprandial State at Baseline and Week 8 | Baseline | 5.49 Percentage of dilation | Standard Deviation 2.489 |
| TAK-085 2 g | FMD With 4-Hours Postprandial State at Baseline and Week 8 | Week 8 | 5.81 Percentage of dilation | Standard Deviation 2.848 |
| TAK-085 4 g | FMD With 4-Hours Postprandial State at Baseline and Week 8 | Baseline | 3.80 Percentage of dilation | Standard Deviation 2.267 |
| TAK-085 4 g | FMD With 4-Hours Postprandial State at Baseline and Week 8 | Week 8 | 4.95 Percentage of dilation | Standard Deviation 2.516 |
Secondary
Number of Participants Reporting One or More Adverse Events (AEs)
Time frame: Up to Week 8
Population: Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAK-085 2 g | Number of Participants Reporting One or More Adverse Events (AEs) | 4 Participants |
| TAK-085 4 g | Number of Participants Reporting One or More Adverse Events (AEs) | 2 Participants |
Secondary
Number of Participants Reporting One or More AEs Related to Blood Pressure in the Sitting Position
Time frame: Up to Week 8
Population: Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAK-085 2 g | Number of Participants Reporting One or More AEs Related to Blood Pressure in the Sitting Position | 0 Participants |
| TAK-085 4 g | Number of Participants Reporting One or More AEs Related to Blood Pressure in the Sitting Position | 0 Participants |
Secondary
Number of Participants Reporting One or More AEs Related to Body Weight
Time frame: Up to Week 8
Population: Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAK-085 2 g | Number of Participants Reporting One or More AEs Related to Body Weight | 0 Participants |
| TAK-085 4 g | Number of Participants Reporting One or More AEs Related to Body Weight | 0 Participants |
Secondary
Number of Participants Reporting One or More AEs Related to Laboratory Tests of Fasting Plasma Glucose
Time frame: Up to Week 8
Population: Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAK-085 2 g | Number of Participants Reporting One or More AEs Related to Laboratory Tests of Fasting Plasma Glucose | 0 Participants |
| TAK-085 4 g | Number of Participants Reporting One or More AEs Related to Laboratory Tests of Fasting Plasma Glucose | 0 Participants |
Secondary
Number of Participants Reporting One or More AEs Related to Pulse in the Sitting Position
Time frame: Up to Week 8
Population: Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAK-085 2 g | Number of Participants Reporting One or More AEs Related to Pulse in the Sitting Position | 0 Participants |
| TAK-085 4 g | Number of Participants Reporting One or More AEs Related to Pulse in the Sitting Position | 0 Participants |
Secondary
Percent Change From Baseline in Arachidonic Acid Concentration With Fasting State at Week 4 and Week 8
Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Arachidonic acid at each time point.
Time frame: Prior to meal at Baseline and Week 4, and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Percent Change From Baseline in Arachidonic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 4 | -6.66 Percent of Change | Standard Deviation 13.212 |
| TAK-085 2 g | Percent Change From Baseline in Arachidonic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 8 | -5.41 Percent of Change | Standard Deviation 15.195 |
| TAK-085 4 g | Percent Change From Baseline in Arachidonic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 4 | -11.80 Percent of Change | Standard Deviation 12.789 |
| TAK-085 4 g | Percent Change From Baseline in Arachidonic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 8 | -20.19 Percent of Change | Standard Deviation 12.2 |
Secondary
Percent Change From Baseline in DHA/AA Ratio With Fasting State at Week 4 and Week 8
Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in DHA/AA ratio at each time point.
Time frame: Prior to meal at Baseline and Week 4, and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Percent Change From Baseline in DHA/AA Ratio With Fasting State at Week 4 and Week 8 | Week 4 | 33.538 Percent of Change | Standard Deviation 27.8356 |
| TAK-085 2 g | Percent Change From Baseline in DHA/AA Ratio With Fasting State at Week 4 and Week 8 | Week 8 | 27.797 Percent of Change | Standard Deviation 26.0796 |
| TAK-085 4 g | Percent Change From Baseline in DHA/AA Ratio With Fasting State at Week 4 and Week 8 | Week 4 | 76.932 Percent of Change | Standard Deviation 52.6408 |
| TAK-085 4 g | Percent Change From Baseline in DHA/AA Ratio With Fasting State at Week 4 and Week 8 | Week 8 | 93.582 Percent of Change | Standard Deviation 69.639 |
Secondary
Percent Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at Week 4 and Week 8
Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Dihomo-gamma-linolenic acid at each time point.
Time frame: Prior to meal at Baseline and Week 4, and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Percent Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 4 | -12.99 Percent of Change | Standard Deviation 23.659 |
| TAK-085 2 g | Percent Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 8 | -15.11 Percent of Change | Standard Deviation 20.541 |
| TAK-085 4 g | Percent Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 4 | -38.81 Percent of Change | Standard Deviation 12.362 |
| TAK-085 4 g | Percent Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 8 | -41.09 Percent of Change | Standard Deviation 12.981 |
Secondary
Percent Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at Week 4 and Week 8
Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Docosahexaenoic acid at each time point.
Time frame: Prior to meal at Baseline and Week 4, and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Percent Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 4 | 24.32 Percent of Change | Standard Deviation 29.608 |
| TAK-085 2 g | Percent Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 8 | 19.69 Percent of Change | Standard Deviation 26.183 |
| TAK-085 4 g | Percent Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 4 | 52.83 Percent of Change | Standard Deviation 35.072 |
| TAK-085 4 g | Percent Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 8 | 51.54 Percent of Change | Standard Deviation 44.898 |
Secondary
Percent Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at Week 4 and Week 8
Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Eicosapentaenoic acid at each time point.
Time frame: Prior to meal at Baseline and Week 4, and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Percent Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 4 | 126.17 Percent of Change | Standard Deviation 85.878 |
| TAK-085 2 g | Percent Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 8 | 137.55 Percent of Change | Standard Deviation 94.717 |
| TAK-085 4 g | Percent Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 4 | 297.49 Percent of Change | Standard Deviation 140.921 |
| TAK-085 4 g | Percent Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at Week 4 and Week 8 | Week 8 | 305.92 Percent of Change | Standard Deviation 153.767 |
Secondary
Percent Change From Baseline in EPA/AA Ratio With Fasting State at Week 4 and Week 8
Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in EPA/AA Ratio at each time point.
Time frame: Prior to meal at Baseline and Week 4, and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Percent Change From Baseline in EPA/AA Ratio With Fasting State at Week 4 and Week 8 | Week 4 | 141.396 Percent of Change | Standard Deviation 94.4914 |
| TAK-085 2 g | Percent Change From Baseline in EPA/AA Ratio With Fasting State at Week 4 and Week 8 | Week 8 | 152.244 Percent of Change | Standard Deviation 95.3802 |
| TAK-085 4 g | Percent Change From Baseline in EPA/AA Ratio With Fasting State at Week 4 and Week 8 | Week 4 | 353.990 Percent of Change | Standard Deviation 162.5131 |
| TAK-085 4 g | Percent Change From Baseline in EPA/AA Ratio With Fasting State at Week 4 and Week 8 | Week 8 | 412.899 Percent of Change | Standard Deviation 202.3624 |
Secondary
Percent Change From Baseline in FMD With 4-Hours Postprandial State at Week 8
FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.
Time frame: 4-hours after meal at Baseline and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAK-085 2 g | Percent Change From Baseline in FMD With 4-Hours Postprandial State at Week 8 | -1.62 Percent of Change | Standard Deviation 31.542 |
| TAK-085 4 g | Percent Change From Baseline in FMD With 4-Hours Postprandial State at Week 8 | 76.79 Percent of Change | Standard Deviation 132.271 |
Secondary
Percent Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8
Time frame: 4-hours after meal at Baseline and Week 4, and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Percent Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8 | Week 4 | 3.8 Percent of Change | Standard Deviation 29.15 |
| TAK-085 2 g | Percent Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8 | Week 8 | -6.0 Percent of Change | Standard Deviation 35.29 |
| TAK-085 4 g | Percent Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8 | Week 4 | -22.4 Percent of Change | Standard Deviation 18.54 |
| TAK-085 4 g | Percent Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8 | Week 8 | -27.2 Percent of Change | Standard Deviation 21.09 |
Secondary
Percent Change From Baseline in TG Level With Fasting State at Week 4 and Week 8
Time frame: Prior to meal at Baseline and Week 4, and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Percent Change From Baseline in TG Level With Fasting State at Week 4 and Week 8 | Week 4 | 4.8 Percent of Change | Standard Deviation 34.17 |
| TAK-085 2 g | Percent Change From Baseline in TG Level With Fasting State at Week 4 and Week 8 | Week 8 | -7.7 Percent of Change | Standard Deviation 31.26 |
| TAK-085 4 g | Percent Change From Baseline in TG Level With Fasting State at Week 4 and Week 8 | Week 4 | -24.5 Percent of Change | Standard Deviation 15.14 |
| TAK-085 4 g | Percent Change From Baseline in TG Level With Fasting State at Week 4 and Week 8 | Week 8 | -23.5 Percent of Change | Standard Deviation 22.12 |
Secondary
TG Level With 4-Hours Postprandial State at Baseline, Week 4 and Week 8
Time frame: 4-hours after meal at Baseline, Week 4, and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | TG Level With 4-Hours Postprandial State at Baseline, Week 4 and Week 8 | Week 8 | 240.5 mg/dL | Standard Deviation 74.66 |
| TAK-085 2 g | TG Level With 4-Hours Postprandial State at Baseline, Week 4 and Week 8 | Baseline | 265.9 mg/dL | Standard Deviation 102.63 |
| TAK-085 2 g | TG Level With 4-Hours Postprandial State at Baseline, Week 4 and Week 8 | Week 4 | 266.1 mg/dL | Standard Deviation 75.18 |
| TAK-085 4 g | TG Level With 4-Hours Postprandial State at Baseline, Week 4 and Week 8 | Baseline | 278.2 mg/dL | Standard Deviation 70.54 |
| TAK-085 4 g | TG Level With 4-Hours Postprandial State at Baseline, Week 4 and Week 8 | Week 4 | 216.2 mg/dL | Standard Deviation 79.11 |
| TAK-085 4 g | TG Level With 4-Hours Postprandial State at Baseline, Week 4 and Week 8 | Week 8 | 202.3 mg/dL | Standard Deviation 78.26 |
Secondary
Triglyceride (TG) Level With Fasting State at Baseline, Week 4, and Week 8
Time frame: Prior to meal at Baseline, Week 4, and Week 8
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 2 g | Triglyceride (TG) Level With Fasting State at Baseline, Week 4, and Week 8 | Baseline | 176.8 mg/dL | Standard Deviation 59.18 |
| TAK-085 2 g | Triglyceride (TG) Level With Fasting State at Baseline, Week 4, and Week 8 | Week 4 | 178.2 mg/dL | Standard Deviation 75.49 |
| TAK-085 2 g | Triglyceride (TG) Level With Fasting State at Baseline, Week 4, and Week 8 | Week 8 | 157.2 mg/dL | Standard Deviation 45.8 |
| TAK-085 4 g | Triglyceride (TG) Level With Fasting State at Baseline, Week 4, and Week 8 | Baseline | 194.4 mg/dL | Standard Deviation 48.57 |
| TAK-085 4 g | Triglyceride (TG) Level With Fasting State at Baseline, Week 4, and Week 8 | Week 4 | 144.6 mg/dL | Standard Deviation 39.36 |
| TAK-085 4 g | Triglyceride (TG) Level With Fasting State at Baseline, Week 4, and Week 8 | Week 8 | 144.9 mg/dL | Standard Deviation 43.05 |