Hyperlipidemia
Conditions
Brief summary
The purpose of this study is to explore the effects of 8-week treatment with omega-3-acid ethyl esters on the lipid and lipoprotein profile in the blood in hyperlipidemic patients receiving a HMG-CoA reductase inhibitor by use of HPLC in comparison with the control group of patients not treated with omega-3-acid ethyl esters.
Detailed description
This study was designed to explore the effects of omega-3-acid ethyl esters on the lipid and lipoprotein profile in the blood in hyperlipidemic patients receiving a hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor in comparison with the control group of patients not treated with omega-3-acid ethyl esters in an unblinded manner by use of high performance liquid chromatography (HPLC) using highly-sensitive gel filtration columns, which is a technique for analyzing lipoprotein. Study participants who gave consent and were assessed as eligible in the eligibility assessment will be stratified by the factors of fasting triacylglycerol (TG; \<300 mg/dL or 300 mg/dL≤) and age (\<65 years or 65 years≤) at the start of the screening period and allocated to either the group treated with omega-3-acid ethyl esters or the group not treated with omega-3-acid ethyl esters (1:1 ratio).
Interventions
DRUGTAK-085
Omega-3-acid ethyl esters (TAK-085) capsule
OTHERNot treated with omega-3-acid ethyl esters
Not treated with omega-3-acid ethyl esters
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 diagnosed as hyperlipidemia. 2. Participants constantly receiving a HMG-CoA reductase inhibitor at a stable dose for at least 4 weeks at the start of the observation period. 3. Participants with fasting TG of 150≤ to \<400 mg/dL measured at the start of the observation period at Visit 1 (Week -4). 4. Participants who, in the opinion of the principal investigator or the investigator, are capable of understanding the content of the clinical study and complying with the study protocol requirements. 5. Participants who can provide written informed consent prior to the conduction of the clinical study procedures. 6. Participants aged ≥20 years at the time of informed consent at Visit 1 (Week -4).
Exclusion criteria
1. Participants who had clinically significant hemorrhagic disorders (e.g., hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, and vitreous hemorrhage) within 24 weeks prior to the start of the observation period, or those who concurrently have the above disorders. 2. Participants who had thyroid disorders (hyperthyroidism or hypothyroidism) within 24 weeks prior to the start of the observation period, those who concurrently have the above disorders, or those who are orally receiving a therapeutic drug for thyroid disorder. 3. Participants in whom the type of HMG-CoA reductase inhibitors was changed within 12 weeks prior to the start of observation period. 4. Participants who received an eicosapentaenoic acid (EPA) preparation or an EPA/docosahexaenoic acid (DHA) preparation (including supplements) within 12 weeks prior to the start of observation period. 5. Participants who started antidyslipidemic agents within 4 weeks prior to the start of observation period. 6. Participants with severe hepatic impairment (e.g., Child-Pugh classification C). 7. Participants who were previously diagnosed as lipoprotein lipase deficiency or apoprotein C-II deficiency. 8. Participants who are concurrently having Cushing's syndrome, uremia, systemic lupus erythematosus (SLE), or serum dysproteinemia. 9. Diabetic participants who are currently receiving thiazolidine or insulin. 10. Participants who are concurrently having hypertension of grade IIINote 1). Note 1: Participants with systolic blood pressure of ≥180 mm Hg or diastolic blood pressure of ≥110 mm Hg regardless of treatment with antihypertensive drugs. 11. 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. 12. Pregnant, lactating or postmenopausal women. 13. Participants with a history of hypersensitivity or allergy for omega-3-acid ethyl esters. 14. Participants participating in other clinical studies. 15. Participants assessed ineligible in the study by the principal investigator or the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction | Baseline, Week 4 and Week 8 | Major 4 lipid constituents refer to cholesterol, triglycerides, free cholesterol, and phospholipid. The reported data are percent of change from baseline in concentration of the each lipid constituents in sdLDL fraction at Week 4 and Week 8. |
| Percent Changes From Baseline in Triglycerides (TG) to Cholesterol Ratio in sdLDL Fraction | Baseline, Week 4, and Week 8 | Reported data are percent of change from baseline in in TG to cholesterol ratio in sdLDL fraction at Week 4 and Week 8. |
| Percent Change From Baseline in Mean Particle Sizes of Small Dense Low Density Lipoprotein-cholesterol (sdLDL-C) and Low Density Lipoprotein-cholesterol (LDL-C) Monitored by Major 4 Lipid Constituents | Baseline, Week 4, and Week 8 | Reported data are percent of change from baseline in mean particle sizes of sdLDL-C and LDL-C monitored by major 4 lipid constituents (cholesterol, triglycerides, free cholesterol, and phospholipid) at Week 4 and Week 8. Here the data were consolidated from results of the two outcome measures (Change in mean particle sizes of sdLDL-C and Change in mean particle sizes of LDL-C) on initial registration information (see History of Change of registration) because sdLDL-C refers to LDL-C which is smaller particle size and heavier density. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in High-density Lipoprotein (HDL) Fraction | Baseline, Week 4 and Week 8 | Major 4 lipid constituents refer to cholesterol, triglycerides, free cholesterol, and phospholipid. The reported data are percent of change from baseline in concentration of the each lipid constituents in HDL Fraction at Week 4 and Week 8. |
| Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Baseline, Week 4 and Week 8 | Fatty acids refer to the following 24 acids; Lauric acid, Myristic acid, Myristoleic acid, Palmitic acid, Palmitoleic acid, Stearic acid, Oleic acid, Linoleic acid, Gamma-linolenic acid, Linolenic acid, Arachic acid, Eicosenoic acid, Eicosadienoic acid, 5-8-11 Eicosatrienoic acid, Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Behenic acid, Erucic acid, Docosatetraenoic acid, Docosapentaenoic acid, Lignoceric acid, Docosahexaenoic acid, and Nervonic acid. The reported data are percent of change from baseline in concentration of these fatty acids in total lipids at Week 4 and Week 8. |
| Percent Changes From Baseline in Eicosatrienoic Acid to Arachidonic Acid (T/T) Ratio in Total Lipids | Baseline, Week 4 and Week 8 | The reported data are percent of change from baseline in T/T ratio in total lipids at Week 4 and Week 8. |
| Percent Changes From Baseline in Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio in Total Lipids | Baseline, Week 4 and Week 8 | The reported data are percent of change from baseline in EPA/AA ratio in total lipids at Week 4 and Week 8. |
| Percent Changes From Baseline in Eicosapentaenoic Acid Plus Docosahexaenoic Acid to Arachidonic Acid (EPA+DHA/AA) Ratio in Total Lipids | Baseline, Week 4 and Week 8 | The reported data are percent of change from baseline in EPA+DHA/AA ratio in total lipids at Week 4 and Week 8. |
| Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Chylomicron (CM) Fraction | Baseline, Week 4 and Week 8 | Major 4 lipid constituents refer to cholesterol, triglycerides, free cholesterol, and phospholipid. The reported data are percent of change from baseline in concentration of the each lipid constituents in CM fraction at Week 4 and Week 8. |
| Change From Baseline in Mean Concentration of sd LDL-C in Total Lipids | Baseline, Week 4 and Week 8 | There were no reporting data for this outcome measure because the data of change in mean concentration of sdLDL-C in total lipids were not collected and analyzed in this study finally. So here the data input for this outcome measure are NA for each arm. |
| Percent Change From Baseline in Concentration of Lipids in the Blood | Baseline, Week 4 and Week 8 | Lipids on this outcome measure include Total cholesterol, Triacylglycerol (TG), HDL-C, non-HDL, and Remnant lipoprotein cholesterol (RemL-C). Reported data are percent of change in concentration of these lipids in the blood at Week 4 and Week 8. |
| Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Baseline, Week 4 and Week 8 | Apolipoproteins on this outcome measure include Apolipoprotein AI, AII, B, B-48, B-100, CII, CIII, CII/III, and E. Reported data are percent of change in concentration of these apolipoproteins in the blood at Week 4 and Week 8. |
| Percent Change From Baseline in Lipoprotein Particle Numbers in the Blood | Baseline, Week 4 and Week 8 | Reported data were percent of changes from baseline in lipoprotein particle numbers in the blood for 4 fractions (CM, VLDL, LDL, and HDL fractions). Data for this outcome measure was reported instead of the outcome measure title of Change from Baseline in particle number of lipids, apoprotein and lipoprotein on registration module (see History of Change of registration). |
| Percent Changes From Baseline in Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio in Total Lipids | Baseline, Week 4 and Week 8 | The reported data are percent of change from baseline in DHA/AA ratio in total lipids at Week 4 and Week 8. |
| Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Very Low-density Lipoprotein (VLDL) Fraction | Baseline, Week 4 and Week 8 | Major 4 lipid constituents refer to cholesterol, triglycerides, free cholesterol, and phospholipid. The reported data are percent of change from baseline in concentration of the each lipid constituents in VLDL Fraction at Week 4 and Week 8. |
| Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Low-density Lipoprotein (LDL) Fraction | Baseline, Week 4 and Week 8 | Major 4 lipid constituents refer to cholesterol, triglycerides, free cholesterol, and phospholipid. The reported data are percent of change from baseline in concentration of the each lipid constituents in LDL Fraction at Week 4 and Week 8. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 7 investigative sites in Japan, from 27 December 2016 to 30 August 2017.
Pre-assignment details
Participants with a historical diagnosis of hyperlipidemia who were inadequately controlled while receiving a hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor were enrolled in one of two groups, treatment group with omega-3-acid ethyl esters (TAK-085) 2 grams (g) and treatment group without TAK-085 (Control Group).
Participants by arm
| Arm | Count |
|---|---|
| TAK-085 4 g A dose of 2 g of omega-3-acid ethyl esters (TAK-085) capsule was orally administered immediately after a meal twice daily (totally 4g per a day) for 8 weeks, plus a stable HMG-CoA reductase inhibitor regimen (started ≥4 weeks prior to informed consent) at a consistent dose. | 24 |
| Control Group Stable HMG-CoA reductase inhibitor regimen at a consistent dose only. | 29 |
| Total | 53 |
Baseline characteristics
| Characteristic | Control Group | Total | TAK-085 4 g |
|---|---|---|---|
| Age, Continuous | 62.3 Years STANDARD_DEVIATION 11.67 | 61.5 Years STANDARD_DEVIATION 11.42 | 60.5 Years STANDARD_DEVIATION 11.28 |
| BMI | 27.39 kg/m^2 STANDARD_DEVIATION 3.746 | 27.34 kg/m^2 STANDARD_DEVIATION 3.317 | 27.27 kg/m^2 STANDARD_DEVIATION 2.791 |
| Cholesterol Concentration in Small Dense Low Density Lipoprotein (sdLDL) Fraction | 32.981 mg/dL STANDARD_DEVIATION 9.1346 | 31.760 mg/dL STANDARD_DEVIATION 7.8879 | 30.285 mg/dL STANDARD_DEVIATION 5.9109 |
| Drinking habit No | 20 Participants | 37 Participants | 17 Participants |
| Drinking habit Yes | 9 Participants | 16 Participants | 7 Participants |
| Duration of Hyperlipemia | 7.76 Years STANDARD_DEVIATION 5.847 | 9.25 Years STANDARD_DEVIATION 6.828 | 11.05 Years STANDARD_DEVIATION 7.59 |
| Fasting Triglycerides | 214.7 Milligram (mg)/deciliter (dL) STANDARD_DEVIATION 73.12 | 211.7 Milligram (mg)/deciliter (dL) STANDARD_DEVIATION 72.91 | 208.0 Milligram (mg)/deciliter (dL) STANDARD_DEVIATION 74.05 |
| Free Cholesterol Concentration in sdLDL Fraction | 9.353 mg/dL STANDARD_DEVIATION 2.3705 | 9.044 mg/dL STANDARD_DEVIATION 2.0986 | 8.670 mg/dL STANDARD_DEVIATION 1.6883 |
| Frequency of Fish Intake About Every Two Days | 6 Participants | 12 Participants | 6 Participants |
| Frequency of Fish Intake About Once or Twice Per Week | 19 Participants | 34 Participants | 15 Participants |
| Frequency of Fish Intake Almost Every Day | 4 Participants | 6 Participants | 2 Participants |
| Frequency of Fish Intake Rarely | 0 Participants | 1 Participants | 1 Participants |
| Height | 167.7 Centimeters (cm) STANDARD_DEVIATION 7.55 | 168.2 Centimeters (cm) STANDARD_DEVIATION 6.87 | 168.9 Centimeters (cm) STANDARD_DEVIATION 6.05 |
| Particle Size of LDL(Cholesterol Monitor) | 25.681 Nanometer (nm) STANDARD_DEVIATION 0.4087 | 25.695 Nanometer (nm) STANDARD_DEVIATION 0.4148 | 25.712 Nanometer (nm) STANDARD_DEVIATION 0.4301 |
| Particle Size of LDL (Free Cholesterol Monitor) | 25.492 nm STANDARD_DEVIATION 0.4263 | 25.523 nm STANDARD_DEVIATION 0.4299 | 25.560 nm STANDARD_DEVIATION 0.4403 |
| Particle Size of LDL (Phospholipid Monitor) | 25.263 nm STANDARD_DEVIATION 0.3945 | 25.296 nm STANDARD_DEVIATION 0.4147 | 25.335 nm STANDARD_DEVIATION 0.4431 |
| Particle Size of LDL (Triglycerides Monitor) | 29.005 nm STANDARD_DEVIATION 0.8946 | 29.173 nm STANDARD_DEVIATION 0.9442 | 29.378 nm STANDARD_DEVIATION 1.0152 |
| Phospholipid Concentration in sdLDL Fraction | 33.860 mg/dL STANDARD_DEVIATION 7.9633 | 32.803 mg/dL STANDARD_DEVIATION 6.8824 | 31.526 mg/dL STANDARD_DEVIATION 5.1749 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Japan | 29 Participants | 53 Participants | 24 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 29 Participants | 52 Participants | 23 Participants |
| Smoking Classification Current smoker | 7 Participants | 12 Participants | 5 Participants |
| Smoking Classification Ex-smoker | 13 Participants | 27 Participants | 14 Participants |
| Smoking Classification Never smoked | 9 Participants | 14 Participants | 5 Participants |
| Triglycerides Concentration in sdLDL Fraction | 7.320 mg/dL STANDARD_DEVIATION 2.0727 | 7.074 mg/dL STANDARD_DEVIATION 1.9556 | 6.778 mg/dL STANDARD_DEVIATION 1.8022 |
| Weight | 77.13 Kilograms (kg) STANDARD_DEVIATION 12.507 | 77.49 Kilograms (kg) STANDARD_DEVIATION 11.257 | 77.93 Kilograms (kg) STANDARD_DEVIATION 9.784 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 29 |
| other Total, other adverse events | 2 / 24 | 0 / 29 |
| serious Total, serious adverse events | 0 / 24 | 0 / 29 |
Outcome results
Primary
Percent Change From Baseline in Mean Particle Sizes of Small Dense Low Density Lipoprotein-cholesterol (sdLDL-C) and Low Density Lipoprotein-cholesterol (LDL-C) Monitored by Major 4 Lipid Constituents
Reported data are percent of change from baseline in mean particle sizes of sdLDL-C and LDL-C monitored by major 4 lipid constituents (cholesterol, triglycerides, free cholesterol, and phospholipid) at Week 4 and Week 8. Here the data were consolidated from results of the two outcome measures (Change in mean particle sizes of sdLDL-C and Change in mean particle sizes of LDL-C) on initial registration information (see History of Change of registration) because sdLDL-C refers to LDL-C which is smaller particle size and heavier density.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 4 g | Percent Change From Baseline in Mean Particle Sizes of Small Dense Low Density Lipoprotein-cholesterol (sdLDL-C) and Low Density Lipoprotein-cholesterol (LDL-C) Monitored by Major 4 Lipid Constituents | Week 4 (Cholesterol Monitor) | 0.56 Percent of Change | Standard Deviation 1.217 |
| TAK-085 4 g | Percent Change From Baseline in Mean Particle Sizes of Small Dense Low Density Lipoprotein-cholesterol (sdLDL-C) and Low Density Lipoprotein-cholesterol (LDL-C) Monitored by Major 4 Lipid Constituents | Week 8 (Cholesterol Monitor) | 0.99 Percent of Change | Standard Deviation 1.192 |
| TAK-085 4 g | Percent Change From Baseline in Mean Particle Sizes of Small Dense Low Density Lipoprotein-cholesterol (sdLDL-C) and Low Density Lipoprotein-cholesterol (LDL-C) Monitored by Major 4 Lipid Constituents | Week 4 (Triglycerides Monitor) | 0.87 Percent of Change | Standard Deviation 6.026 |
| TAK-085 4 g | Percent Change From Baseline in Mean Particle Sizes of Small Dense Low Density Lipoprotein-cholesterol (sdLDL-C) and Low Density Lipoprotein-cholesterol (LDL-C) Monitored by Major 4 Lipid Constituents | Week 8 (Triglycerides Monitor) | 2.11 Percent of Change | Standard Deviation 2.715 |
| TAK-085 4 g | Percent Change From Baseline in Mean Particle Sizes of Small Dense Low Density Lipoprotein-cholesterol (sdLDL-C) and Low Density Lipoprotein-cholesterol (LDL-C) Monitored by Major 4 Lipid Constituents | Week 4 (Free Cholesterol Monitor) | 0.79 Percent of Change | Standard Deviation 1.247 |
| TAK-085 4 g | Percent Change From Baseline in Mean Particle Sizes of Small Dense Low Density Lipoprotein-cholesterol (sdLDL-C) and Low Density Lipoprotein-cholesterol (LDL-C) Monitored by Major 4 Lipid Constituents | Week 8 (Free Cholesterol Monitor) | 0.90 Percent of Change | Standard Deviation 1.407 |
| TAK-085 4 g | Percent Change From Baseline in Mean Particle Sizes of Small Dense Low Density Lipoprotein-cholesterol (sdLDL-C) and Low Density Lipoprotein-cholesterol (LDL-C) Monitored by Major 4 Lipid Constituents | Week 4 (Phospholipid Monitor) | 0.63 Percent of Change | Standard Deviation 1.464 |
| TAK-085 4 g | Percent Change From Baseline in Mean Particle Sizes of Small Dense Low Density Lipoprotein-cholesterol (sdLDL-C) and Low Density Lipoprotein-cholesterol (LDL-C) Monitored by Major 4 Lipid Constituents | Week 8 (Phospholipid Monitor) | 0.99 Percent of Change | Standard Deviation 1.316 |
| Control Group | Percent Change From Baseline in Mean Particle Sizes of Small Dense Low Density Lipoprotein-cholesterol (sdLDL-C) and Low Density Lipoprotein-cholesterol (LDL-C) Monitored by Major 4 Lipid Constituents | Week 8 (Phospholipid Monitor) | 0.09 Percent of Change | Standard Deviation 1.431 |
| Control Group | Percent Change From Baseline in Mean Particle Sizes of Small Dense Low Density Lipoprotein-cholesterol (sdLDL-C) and Low Density Lipoprotein-cholesterol (LDL-C) Monitored by Major 4 Lipid Constituents | Week 4 (Cholesterol Monitor) | -0.39 Percent of Change | Standard Deviation 0.82 |
| Control Group | Percent Change From Baseline in Mean Particle Sizes of Small Dense Low Density Lipoprotein-cholesterol (sdLDL-C) and Low Density Lipoprotein-cholesterol (LDL-C) Monitored by Major 4 Lipid Constituents | Week 4 (Free Cholesterol Monitor) | -0.16 Percent of Change | Standard Deviation 0.953 |
| Control Group | Percent Change From Baseline in Mean Particle Sizes of Small Dense Low Density Lipoprotein-cholesterol (sdLDL-C) and Low Density Lipoprotein-cholesterol (LDL-C) Monitored by Major 4 Lipid Constituents | Week 8 (Cholesterol Monitor) | -0.08 Percent of Change | Standard Deviation 1.274 |
| Control Group | Percent Change From Baseline in Mean Particle Sizes of Small Dense Low Density Lipoprotein-cholesterol (sdLDL-C) and Low Density Lipoprotein-cholesterol (LDL-C) Monitored by Major 4 Lipid Constituents | Week 4 (Phospholipid Monitor) | -0.23 Percent of Change | Standard Deviation 1.018 |
| Control Group | Percent Change From Baseline in Mean Particle Sizes of Small Dense Low Density Lipoprotein-cholesterol (sdLDL-C) and Low Density Lipoprotein-cholesterol (LDL-C) Monitored by Major 4 Lipid Constituents | Week 4 (Triglycerides Monitor) | -0.06 Percent of Change | Standard Deviation 1.367 |
| Control Group | Percent Change From Baseline in Mean Particle Sizes of Small Dense Low Density Lipoprotein-cholesterol (sdLDL-C) and Low Density Lipoprotein-cholesterol (LDL-C) Monitored by Major 4 Lipid Constituents | Week 8 (Free Cholesterol Monitor) | 0.07 Percent of Change | Standard Deviation 1.361 |
| Control Group | Percent Change From Baseline in Mean Particle Sizes of Small Dense Low Density Lipoprotein-cholesterol (sdLDL-C) and Low Density Lipoprotein-cholesterol (LDL-C) Monitored by Major 4 Lipid Constituents | Week 8 (Triglycerides Monitor) | 0.52 Percent of Change | Standard Deviation 3.155 |
Comparison: The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by triglycerides using an ANCOVA model.p-value: 0.442895% CI: [-2.884, 5.991]ANCOVA
Comparison: The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by cholesterol using an ANCOVA model.p-value: 0.00495% CI: [0.356, 1.776]ANCOVA
Comparison: The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by free cholesterol using an ANCOVA model.p-value: 0.05795% CI: [-0.024, 1.544]ANCOVA
Comparison: The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by phospholipid using an ANCOVA model.p-value: 0.03695% CI: [0.057, 1.62]ANCOVA
Primary
Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction
Major 4 lipid constituents refer to cholesterol, triglycerides, free cholesterol, and phospholipid. The reported data are percent of change from baseline in concentration of the each lipid constituents in sdLDL fraction at Week 4 and Week 8.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction | Cholesterol at Week 4 | -6.50 Percent of Change | Standard Deviation 15.745 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction | Cholesterol at Week 8 | -12.35 Percent of Change | Standard Deviation 13.519 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction | Triglycerides at Week 4 | -2.87 Percent of Change | Standard Deviation 22.917 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction | Triglycerides at Week 8 | -6.50 Percent of Change | Standard Deviation 22.615 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction | Free Cholesterol at Week 4 | -6.32 Percent of Change | Standard Deviation 12.483 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction | Free Cholesterol at Week 8 | -6.94 Percent of Change | Standard Deviation 16.639 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction | Phospholipid at Week 4 | -8.31 Percent of Change | Standard Deviation 11.396 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction | Phospholipid at Week 8 | -10.37 Percent of Change | Standard Deviation 13.919 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction | Phospholipid at Week 8 | 1.09 Percent of Change | Standard Deviation 13.44 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction | Cholesterol at Week 4 | 5.05 Percent of Change | Standard Deviation 11.401 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction | Free Cholesterol at Week 4 | 2.14 Percent of Change | Standard Deviation 14.048 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction | Cholesterol at Week 8 | 4.64 Percent of Change | Standard Deviation 17.845 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction | Phospholipid at Week 4 | 2.10 Percent of Change | Standard Deviation 11.297 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction | Triglycerides at Week 4 | 9.71 Percent of Change | Standard Deviation 23.437 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction | Free Cholesterol at Week 8 | 3.42 Percent of Change | Standard Deviation 14.516 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction | Triglycerides at Week 8 | 2.74 Percent of Change | Standard Deviation 20.317 |
Comparison: The least square (LS) mean percentage change was compared between treatment groups with cholesterol concentration in sd LDL fraction at Week 8 using an ANCOVA model.p-value: 0.000495% CI: [-26.344, -7.95]ANCOVA
Comparison: The least square (LS) mean percentage change was compared between treatment groups with triglycerides concentration in sd LDL fraction at Week 8 using an ANCOVA model.p-value: 0.114195% CI: [-21.986, 2.439]ANCOVA
Comparison: The least square (LS) mean percentage change was compared between treatment groups with free cholesterol concentration in sd LDL fraction at Week 8 using an ANCOVA model.p-value: 0.024895% CI: [-19.143, -1.349]ANCOVA
Comparison: The least square (LS) mean percentage change was compared between treatment groups with phospholipid concentration in sd LDL fraction at Week 8 using an ANCOVA model.p-value: 0.004795% CI: [-19.34, -3.682]ANCOVA
Primary
Percent Changes From Baseline in Triglycerides (TG) to Cholesterol Ratio in sdLDL Fraction
Reported data are percent of change from baseline in in TG to cholesterol ratio in sdLDL fraction at Week 4 and Week 8.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 4 g | Percent Changes From Baseline in Triglycerides (TG) to Cholesterol Ratio in sdLDL Fraction | Week 4 | 4.48 Percent of Change | Standard Deviation 21.423 |
| TAK-085 4 g | Percent Changes From Baseline in Triglycerides (TG) to Cholesterol Ratio in sdLDL Fraction | Week 8 | 8.64 Percent of Change | Standard Deviation 31.398 |
| Control Group | Percent Changes From Baseline in Triglycerides (TG) to Cholesterol Ratio in sdLDL Fraction | Week 8 | -0.94 Percent of Change | Standard Deviation 17.267 |
| Control Group | Percent Changes From Baseline in Triglycerides (TG) to Cholesterol Ratio in sdLDL Fraction | Week 4 | 5.66 Percent of Change | Standard Deviation 25.908 |
Comparison: The least square (LS) mean percentage change was compared between treatment groups with TG to cholesterol ratio in sd LDL fraction at Week 8 using an ANCOVA model.p-value: 0.182695% CI: [-4.623, 23.622]ANCOVA
Secondary
Change From Baseline in Mean Concentration of sd LDL-C in Total Lipids
There were no reporting data for this outcome measure because the data of change in mean concentration of sdLDL-C in total lipids were not collected and analyzed in this study finally. So here the data input for this outcome measure are NA for each arm.
Time frame: Baseline, Week 4 and Week 8
Population: There were no reporting data for this outcome measure because the data of change in mean concentration of sdLDL-C in total lipids were not collected and analyzed in this study finally.
Secondary
Percent Change From Baseline in Concentration of Apolipoproteins in the Blood
Apolipoproteins on this outcome measure include Apolipoprotein AI, AII, B, B-48, B-100, CII, CIII, CII/III, and E. Reported data are percent of change in concentration of these apolipoproteins in the blood at Week 4 and Week 8.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 4 g | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein AI at Week 4 | -2.54 Percent of Change | Standard Deviation 5.068 |
| TAK-085 4 g | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein AI at Week 8 | -4.25 Percent of Change | Standard Deviation 7.541 |
| TAK-085 4 g | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein AII at Week 4 | -6.56 Percent of Change | Standard Deviation 6.117 |
| TAK-085 4 g | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein AII at Week 8 | -8.17 Percent of Change | Standard Deviation 7.326 |
| TAK-085 4 g | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein B at Week 4 | -3.48 Percent of Change | Standard Deviation 7.515 |
| TAK-085 4 g | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein B at Week 8 | -6.57 Percent of Change | Standard Deviation 9.763 |
| TAK-085 4 g | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein B-48 at Week 4 | -10.38 Percent of Change | Standard Deviation 41.138 |
| TAK-085 4 g | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein B-48 at Week 8 | -20.50 Percent of Change | Standard Deviation 35.739 |
| TAK-085 4 g | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein B-100 at Week 4 | -8.30 Percent of Change | Standard Deviation 13.124 |
| TAK-085 4 g | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein B-100 at Week 8 | -9.09 Percent of Change | Standard Deviation 13.453 |
| TAK-085 4 g | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein CII at Week 4 | -11.69 Percent of Change | Standard Deviation 15.395 |
| TAK-085 4 g | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein CII at Week 8 | -17.80 Percent of Change | Standard Deviation 17.579 |
| TAK-085 4 g | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein CIII at Week 4 | -7.29 Percent of Change | Standard Deviation 15.338 |
| TAK-085 4 g | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein CIII at Week 8 | -12.14 Percent of Change | Standard Deviation 15.585 |
| TAK-085 4 g | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein CII/III at Week 4 | -4.02 Percent of Change | Standard Deviation 13.076 |
| TAK-085 4 g | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein CII/III at Week 8 | -6.02 Percent of Change | Standard Deviation 14.231 |
| TAK-085 4 g | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein E at Week 4 | -1.57 Percent of Change | Standard Deviation 19.222 |
| TAK-085 4 g | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein E at Week 8 | -4.24 Percent of Change | Standard Deviation 18.788 |
| Control Group | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein CIII at Week 8 | 3.01 Percent of Change | Standard Deviation 16.661 |
| Control Group | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein AI at Week 4 | 1.39 Percent of Change | Standard Deviation 5.226 |
| Control Group | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein B-100 at Week 8 | 2.39 Percent of Change | Standard Deviation 14.516 |
| Control Group | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein AI at Week 8 | 0.30 Percent of Change | Standard Deviation 6.54 |
| Control Group | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein E at Week 8 | 0.30 Percent of Change | Standard Deviation 13.578 |
| Control Group | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein AII at Week 4 | 2.72 Percent of Change | Standard Deviation 7.886 |
| Control Group | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein CII at Week 4 | 8.07 Percent of Change | Standard Deviation 16.006 |
| Control Group | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein AII at Week 8 | 2.86 Percent of Change | Standard Deviation 8.773 |
| Control Group | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein CII/III at Week 4 | 1.58 Percent of Change | Standard Deviation 18.066 |
| Control Group | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein B at Week 4 | 2.14 Percent of Change | Standard Deviation 8.674 |
| Control Group | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein CII at Week 8 | 6.04 Percent of Change | Standard Deviation 21.676 |
| Control Group | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein B at Week 8 | 1.63 Percent of Change | Standard Deviation 8.054 |
| Control Group | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein E at Week 4 | 4.38 Percent of Change | Standard Deviation 15.518 |
| Control Group | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein B-48 at Week 4 | 39.56 Percent of Change | Standard Deviation 84.921 |
| Control Group | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein CIII at Week 4 | 7.57 Percent of Change | Standard Deviation 15.115 |
| Control Group | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein B-48 at Week 8 | 28.49 Percent of Change | Standard Deviation 71.554 |
| Control Group | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein CII/III at Week 8 | 3.36 Percent of Change | Standard Deviation 16.356 |
| Control Group | Percent Change From Baseline in Concentration of Apolipoproteins in the Blood | Apolipoprotein B-100 at Week 4 | 0.79 Percent of Change | Standard Deviation 9.067 |
Secondary
Percent Change From Baseline in Concentration of Lipids in the Blood
Lipids on this outcome measure include Total cholesterol, Triacylglycerol (TG), HDL-C, non-HDL, and Remnant lipoprotein cholesterol (RemL-C). Reported data are percent of change in concentration of these lipids in the blood at Week 4 and Week 8.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 4 g | Percent Change From Baseline in Concentration of Lipids in the Blood | TG at Week 8 | -14.51 Percent of Change | Standard Deviation 32.86 |
| TAK-085 4 g | Percent Change From Baseline in Concentration of Lipids in the Blood | Total Cholesterol at Week 4 | -5.74 Percent of Change | Standard Deviation 7.68 |
| TAK-085 4 g | Percent Change From Baseline in Concentration of Lipids in the Blood | Total Cholesterol at Week 8 | -7.07 Percent of Change | Standard Deviation 8.325 |
| TAK-085 4 g | Percent Change From Baseline in Concentration of Lipids in the Blood | TG at Week 4 | -16.57 Percent of Change | Standard Deviation 27.101 |
| TAK-085 4 g | Percent Change From Baseline in Concentration of Lipids in the Blood | HDL-C (Direct) at Week 4 | -0.36 Percent of Change | Standard Deviation 8.29 |
| TAK-085 4 g | Percent Change From Baseline in Concentration of Lipids in the Blood | HDL-C (Direct) at Week 8 | -1.42 Percent of Change | Standard Deviation 10.575 |
| TAK-085 4 g | Percent Change From Baseline in Concentration of Lipids in the Blood | Non-HDL at Week 4 | -7.71 Percent of Change | Standard Deviation 10.152 |
| TAK-085 4 g | Percent Change From Baseline in Concentration of Lipids in the Blood | Non-HDL at Week 8 | -9.30 Percent of Change | Standard Deviation 11.473 |
| TAK-085 4 g | Percent Change From Baseline in Concentration of Lipids in the Blood | RemL-C at Week 4 | -26.62 Percent of Change | Standard Deviation 29.222 |
| TAK-085 4 g | Percent Change From Baseline in Concentration of Lipids in the Blood | RemL-C at Week 8 | -26.07 Percent of Change | Standard Deviation 38.146 |
| Control Group | Percent Change From Baseline in Concentration of Lipids in the Blood | Non-HDL at Week 8 | 2.07 Percent of Change | Standard Deviation 10.898 |
| Control Group | Percent Change From Baseline in Concentration of Lipids in the Blood | TG at Week 4 | 9.60 Percent of Change | Standard Deviation 34.407 |
| Control Group | Percent Change From Baseline in Concentration of Lipids in the Blood | HDL-C (Direct) at Week 8 | 1.16 Percent of Change | Standard Deviation 8.305 |
| Control Group | Percent Change From Baseline in Concentration of Lipids in the Blood | Total Cholesterol at Week 4 | 2.07 Percent of Change | Standard Deviation 8.336 |
| Control Group | Percent Change From Baseline in Concentration of Lipids in the Blood | RemL-C at Week 8 | -4.89 Percent of Change | Standard Deviation 27.442 |
| Control Group | Percent Change From Baseline in Concentration of Lipids in the Blood | Total Cholesterol at Week 8 | 1.43 Percent of Change | Standard Deviation 8.267 |
| Control Group | Percent Change From Baseline in Concentration of Lipids in the Blood | Non-HDL at Week 4 | 2.65 Percent of Change | Standard Deviation 9.978 |
| Control Group | Percent Change From Baseline in Concentration of Lipids in the Blood | TG at Week 8 | -2.49 Percent of Change | Standard Deviation 22.313 |
| Control Group | Percent Change From Baseline in Concentration of Lipids in the Blood | RemL-C at Week 4 | 15.84 Percent of Change | Standard Deviation 47.272 |
| Control Group | Percent Change From Baseline in Concentration of Lipids in the Blood | HDL-C (Direct) at Week 4 | 0.70 Percent of Change | Standard Deviation 9.386 |
Secondary
Percent Change From Baseline in Lipoprotein Particle Numbers in the Blood
Reported data were percent of changes from baseline in lipoprotein particle numbers in the blood for 4 fractions (CM, VLDL, LDL, and HDL fractions). Data for this outcome measure was reported instead of the outcome measure title of Change from Baseline in particle number of lipids, apoprotein and lipoprotein on registration module (see History of Change of registration).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 4 g | Percent Change From Baseline in Lipoprotein Particle Numbers in the Blood | CM Fraction at Week 4 | -37.40 Percent of Change | Standard Deviation 50.191 |
| TAK-085 4 g | Percent Change From Baseline in Lipoprotein Particle Numbers in the Blood | CM Fraction at Week 8 | -33.40 Percent of Change | Standard Deviation 54.049 |
| TAK-085 4 g | Percent Change From Baseline in Lipoprotein Particle Numbers in the Blood | VLDL Fraction at Week 4 | -6.20 Percent of Change | Standard Deviation 16.087 |
| TAK-085 4 g | Percent Change From Baseline in Lipoprotein Particle Numbers in the Blood | VLDL Fraction at Week 8 | -9.88 Percent of Change | Standard Deviation 17.551 |
| TAK-085 4 g | Percent Change From Baseline in Lipoprotein Particle Numbers in the Blood | LDL Fraction at Week 4 | -4.58 Percent of Change | Standard Deviation 10.413 |
| TAK-085 4 g | Percent Change From Baseline in Lipoprotein Particle Numbers in the Blood | LDL Fraction at Week 8 | -7.43 Percent of Change | Standard Deviation 9.993 |
| TAK-085 4 g | Percent Change From Baseline in Lipoprotein Particle Numbers in the Blood | HDL Fraction at Week 4 | -4.31 Percent of Change | Standard Deviation 5.517 |
| TAK-085 4 g | Percent Change From Baseline in Lipoprotein Particle Numbers in the Blood | HDL Fraction at Week 8 | -6.33 Percent of Change | Standard Deviation 6.567 |
| Control Group | Percent Change From Baseline in Lipoprotein Particle Numbers in the Blood | HDL Fraction at Week 8 | 1.37 Percent of Change | Standard Deviation 7.687 |
| Control Group | Percent Change From Baseline in Lipoprotein Particle Numbers in the Blood | CM Fraction at Week 4 | 42.88 Percent of Change | Standard Deviation 134.849 |
| Control Group | Percent Change From Baseline in Lipoprotein Particle Numbers in the Blood | LDL Fraction at Week 4 | 2.39 Percent of Change | Standard Deviation 9.059 |
| Control Group | Percent Change From Baseline in Lipoprotein Particle Numbers in the Blood | CM Fraction at Week 8 | -3.70 Percent of Change | Standard Deviation 56.198 |
| Control Group | Percent Change From Baseline in Lipoprotein Particle Numbers in the Blood | HDL Fraction at Week 4 | 1.80 Percent of Change | Standard Deviation 5.893 |
| Control Group | Percent Change From Baseline in Lipoprotein Particle Numbers in the Blood | VLDL Fraction at Week 4 | 5.29 Percent of Change | Standard Deviation 14.765 |
| Control Group | Percent Change From Baseline in Lipoprotein Particle Numbers in the Blood | LDL Fraction at Week 8 | 3.07 Percent of Change | Standard Deviation 11.43 |
| Control Group | Percent Change From Baseline in Lipoprotein Particle Numbers in the Blood | VLDL Fraction at Week 8 | 2.37 Percent of Change | Standard Deviation 13.808 |
Secondary
Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids
Fatty acids refer to the following 24 acids; Lauric acid, Myristic acid, Myristoleic acid, Palmitic acid, Palmitoleic acid, Stearic acid, Oleic acid, Linoleic acid, Gamma-linolenic acid, Linolenic acid, Arachic acid, Eicosenoic acid, Eicosadienoic acid, 5-8-11 Eicosatrienoic acid, Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Behenic acid, Erucic acid, Docosatetraenoic acid, Docosapentaenoic acid, Lignoceric acid, Docosahexaenoic acid, and Nervonic acid. The reported data are percent of change from baseline in concentration of these fatty acids in total lipids at Week 4 and Week 8.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Linoleic Acid at Week 8 | -11.84 Percent of Change | Standard Deviation 16.303 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | 5-8-11 Eicosatrienoic Acid at Week 4 | -42.51 Percent of Change | Standard Deviation 23.478 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | 5-8-11 Eicosatrienoic Acid at Week 8 | -48.16 Percent of Change | Standard Deviation 24.514 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Dihomo-gamma-linolenic Acid at Week 4 | -38.14 Percent of Change | Standard Deviation 15.452 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Dihomo-gamma-linolenic Acid at Week 8 | -37.18 Percent of Change | Standard Deviation 15.933 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Arachidonic Acid at Week 4 | -16.23 Percent of Change | Standard Deviation 11.911 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Erucic Acid at Week 8 | -18.05 Percent of Change | Standard Deviation 71.36 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Arachidonic Acid at Week 8 | -18.35 Percent of Change | Standard Deviation 14.448 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Eicosapentaenoic Acid at Week 8 | 238.48 Percent of Change | Standard Deviation 211.242 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Behenic Acid at Week 4 | -3.33 Percent of Change | Standard Deviation 47.184 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Behenic Acid at Week 8 | -0.41 Percent of Change | Standard Deviation 48.418 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Erucic Acid at Week 4 | 27.58 Percent of Change | Standard Deviation 279.981 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Lignoceric Acid at Week 4 | -9.06 Percent of Change | Standard Deviation 20.062 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Docosatetraenoic Acid at Week 4 | -36.43 Percent of Change | Standard Deviation 17.765 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Docosatetraenoic Acid at Week 8 | -37.74 Percent of Change | Standard Deviation 17.764 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Docosapentaenoic Acid at Week 4 | 18.16 Percent of Change | Standard Deviation 27.789 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Docosapentaenoic Acid at Week 8 | 19.89 Percent of Change | Standard Deviation 33.735 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Lignoceric Acid at Week 8 | -5.01 Percent of Change | Standard Deviation 25.548 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Docosahexaenoic Acid at Week 4 | 30.71 Percent of Change | Standard Deviation 25.367 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Docosahexaenoic Acid at Week 8 | 34.00 Percent of Change | Standard Deviation 41.055 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Nervonic Acid Week 4 | -8.61 Percent of Change | Standard Deviation 14.334 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Nervonic Acid Week 8 | -7.82 Percent of Change | Standard Deviation 15.48 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Eicosapentaenoic Acid at Week 4 | 224.30 Percent of Change | Standard Deviation 155.842 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Oleic Acid at Week 8 | -13.77 Percent of Change | Standard Deviation 25.958 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Lauric Acid at Week 4 | -13.26 Percent of Change | Standard Deviation 56.101 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Lauric Acid at Week 8 | 6.84 Percent of Change | Standard Deviation 85.494 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Myristic Acid at Week 4 | -21.37 Percent of Change | Standard Deviation 26.046 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Myristic Acid at Week 8 | -13.31 Percent of Change | Standard Deviation 33.571 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Myristoleic Acid at Week 4 | -31.40 Percent of Change | Standard Deviation 25.83 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Myristoleic Acid at Week 8 | -8.54 Percent of Change | Standard Deviation 100.145 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Palmitic Acid at Week 4 | -12.49 Percent of Change | Standard Deviation 20.682 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Palmitic Acid at Week 8 | -9.62 Percent of Change | Standard Deviation 22.355 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Palmitoleic Acid at Week 4 | -22.35 Percent of Change | Standard Deviation 22.371 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Palmitoleic Acid at Week 8 | -19.25 Percent of Change | Standard Deviation 27.584 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Stearic Acid at Week 4 | -4.74 Percent of Change | Standard Deviation 22.322 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Stearic Acid at Week 8 | -3.17 Percent of Change | Standard Deviation 24.102 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Oleic Acid at Week 4 | -17.77 Percent of Change | Standard Deviation 23.295 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Linoleic Acid at Week 4 | -10.47 Percent of Change | Standard Deviation 17.286 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Gamma-linolenic Acid at Week 4 | -34.84 Percent of Change | Standard Deviation 17.846 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Gamma-linolenic Acid at Week 8 | -35.21 Percent of Change | Standard Deviation 19.17 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Linolenic Acid at Week 4 | -9.50 Percent of Change | Standard Deviation 26.598 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Linolenic Acid at Week 8 | -7.27 Percent of Change | Standard Deviation 30.301 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Arachic Acid at Week 4 | -15.59 Percent of Change | Standard Deviation 32.158 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Arachic Acid at Week 8 | -7.11 Percent of Change | Standard Deviation 43.51 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Eicosenoic Acid at Week 4 | -22.66 Percent of Change | Standard Deviation 30.315 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Eicosenoic Acid at Week 8 | -19.43 Percent of Change | Standard Deviation 28.872 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Eicosadienoic Acid at Week 4 | -23.82 Percent of Change | Standard Deviation 18.803 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Eicosadienoic Acid at Week 8 | -21.50 Percent of Change | Standard Deviation 21.967 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Linolenic Acid at Week 8 | -0.50 Percent of Change | Standard Deviation 25.026 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Eicosadienoic Acid at Week 8 | -3.17 Percent of Change | Standard Deviation 18.978 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Lauric Acid at Week 4 | 50.65 Percent of Change | Standard Deviation 86.467 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Erucic Acid at Week 4 | 91.40 Percent of Change | Standard Deviation 214.836 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Oleic Acid at Week 4 | 3.28 Percent of Change | Standard Deviation 19.641 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | 5-8-11 Eicosatrienoic Acid at Week 8 | 13.24 Percent of Change | Standard Deviation 38.481 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Lauric Acid at Week 8 | 34.60 Percent of Change | Standard Deviation 138.684 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Dihomo-gamma-linolenic Acid at Week 4 | 0.89 Percent of Change | Standard Deviation 17.847 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Eicosenoic Acid at Week 4 | 6.82 Percent of Change | Standard Deviation 41.15 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Dihomo-gamma-linolenic Acid at Week 8 | 1.98 Percent of Change | Standard Deviation 22.295 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Myristic Acid at Week 4 | 24.68 Percent of Change | Standard Deviation 54.142 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Arachidonic Acid at Week 4 | -1.97 Percent of Change | Standard Deviation 13.223 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Linoleic Acid at Week 4 | 2.93 Percent of Change | Standard Deviation 12.616 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | 5-8-11 Eicosatrienoic Acid at Week 4 | 17.71 Percent of Change | Standard Deviation 68.061 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Myristic Acid at Week 8 | 5.96 Percent of Change | Standard Deviation 32.534 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Eicosapentaenoic Acid at Week 4 | 16.58 Percent of Change | Standard Deviation 53.986 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Linoleic Acid at Week 8 | -0.33 Percent of Change | Standard Deviation 14.748 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Eicosapentaenoic Acid at Week 8 | 29.05 Percent of Change | Standard Deviation 83.267 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Myristoleic Acid at Week 4 | 32.50 Percent of Change | Standard Deviation 77.309 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Behenic Acid at Week 4 | -0.72 Percent of Change | Standard Deviation 36.672 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Arachic Acid at Week 4 | 8.20 Percent of Change | Standard Deviation 35.594 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Behenic Acid at Week 8 | 4.09 Percent of Change | Standard Deviation 39.343 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Myristoleic Acid at Week 8 | -0.55 Percent of Change | Standard Deviation 37.18 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Gamma-linolenic Acid at Week 4 | 7.82 Percent of Change | Standard Deviation 35.906 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Erucic Acid at Week 8 | 139.93 Percent of Change | Standard Deviation 376.748 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Palmitic Acid at Week 4 | 5.77 Percent of Change | Standard Deviation 17.277 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Docosatetraenoic Acid at Week 4 | 4.94 Percent of Change | Standard Deviation 23.847 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Eicosadienoic Acid at Week 4 | 0.31 Percent of Change | Standard Deviation 14.078 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Docosatetraenoic Acid at Week 8 | 1.07 Percent of Change | Standard Deviation 21.927 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Palmitic Acid at Week 8 | -2.63 Percent of Change | Standard Deviation 15.549 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Docosapentaenoic Acid at Week 4 | 5.83 Percent of Change | Standard Deviation 22.423 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Gamma-linolenic Acid at Week 8 | -1.63 Percent of Change | Standard Deviation 23.426 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Docosapentaenoic Acid at Week 8 | 5.78 Percent of Change | Standard Deviation 25.442 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Lignoceric Acid at Week 4 | -2.00 Percent of Change | Standard Deviation 20.004 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Palmitoleic Acid at Week 4 | 5.53 Percent of Change | Standard Deviation 29.987 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Lignoceric Acid at Week 8 | -2.33 Percent of Change | Standard Deviation 24.698 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Arachic Acid at Week 8 | 2.01 Percent of Change | Standard Deviation 32.969 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Docosahexaenoic Acid at Week 4 | 3.10 Percent of Change | Standard Deviation 20.643 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Palmitoleic Acid at Week 8 | -1.17 Percent of Change | Standard Deviation 22.775 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Docosahexaenoic Acid at Week 8 | 7.32 Percent of Change | Standard Deviation 27.833 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Linolenic Acid at Week 4 | 12.09 Percent of Change | Standard Deviation 34.208 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Nervonic Acid Week 4 | 5.98 Percent of Change | Standard Deviation 25.02 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Stearic Acid at Week 4 | 4.03 Percent of Change | Standard Deviation 16.408 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Nervonic Acid Week 8 | 13.04 Percent of Change | Standard Deviation 29.043 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Arachidonic Acid at Week 8 | -2.37 Percent of Change | Standard Deviation 13.22 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Eicosenoic Acid at Week 8 | 0.80 Percent of Change | Standard Deviation 27.505 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Stearic Acid at Week 8 | 0.12 Percent of Change | Standard Deviation 14.957 |
| Control Group | Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids | Oleic Acid at Week 8 | -4.90 Percent of Change | Standard Deviation 15.856 |
Secondary
Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Chylomicron (CM) Fraction
Major 4 lipid constituents refer to cholesterol, triglycerides, free cholesterol, and phospholipid. The reported data are percent of change from baseline in concentration of the each lipid constituents in CM fraction at Week 4 and Week 8.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Chylomicron (CM) Fraction | Cholesterol at Week 4 | -38.03 Percent of Change | Standard Deviation 53.008 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Chylomicron (CM) Fraction | Cholesterol at Week 8 | -32.92 Percent of Change | Standard Deviation 60.17 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Chylomicron (CM) Fraction | Triglycerides at Week 4 | -37.22 Percent of Change | Standard Deviation 49.604 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Chylomicron (CM) Fraction | Triglycerides at Week 8 | -33.32 Percent of Change | Standard Deviation 52.994 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Chylomicron (CM) Fraction | Free Cholesterol at Week 4 | -38.13 Percent of Change | Standard Deviation 50.57 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Chylomicron (CM) Fraction | Free Cholesterol at Week 8 | -30.33 Percent of Change | Standard Deviation 65.974 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Chylomicron (CM) Fraction | Phospholipid at Week 4 | -40.25 Percent of Change | Standard Deviation 61.678 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Chylomicron (CM) Fraction | Phospholipid at Week 8 | -38.00 Percent of Change | Standard Deviation 64.13 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Chylomicron (CM) Fraction | Phospholipid at Week 8 | 1.15 Percent of Change | Standard Deviation 92.004 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Chylomicron (CM) Fraction | Cholesterol at Week 4 | 47.42 Percent of Change | Standard Deviation 149.946 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Chylomicron (CM) Fraction | Free Cholesterol at Week 4 | 60.20 Percent of Change | Standard Deviation 189.062 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Chylomicron (CM) Fraction | Cholesterol at Week 8 | -0.68 Percent of Change | Standard Deviation 65.088 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Chylomicron (CM) Fraction | Phospholipid at Week 4 | 48.94 Percent of Change | Standard Deviation 118.843 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Chylomicron (CM) Fraction | Triglycerides at Week 4 | 42.62 Percent of Change | Standard Deviation 132.804 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Chylomicron (CM) Fraction | Free Cholesterol at Week 8 | 2.37 Percent of Change | Standard Deviation 71.895 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Chylomicron (CM) Fraction | Triglycerides at Week 8 | -3.74 Percent of Change | Standard Deviation 55.812 |
Secondary
Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in High-density Lipoprotein (HDL) Fraction
Major 4 lipid constituents refer to cholesterol, triglycerides, free cholesterol, and phospholipid. The reported data are percent of change from baseline in concentration of the each lipid constituents in HDL Fraction at Week 4 and Week 8.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in High-density Lipoprotein (HDL) Fraction | Cholesterol at Week 4 | -1.49 Percent of Change | Standard Deviation 7.316 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in High-density Lipoprotein (HDL) Fraction | Free Cholesterol at Week 4 | -2.56 Percent of Change | Standard Deviation 9.832 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in High-density Lipoprotein (HDL) Fraction | Triglycerides at Week 4 | -9.07 Percent of Change | Standard Deviation 23.323 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in High-density Lipoprotein (HDL) Fraction | Free Cholesterol at Week 8 | -3.31 Percent of Change | Standard Deviation 12.969 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in High-density Lipoprotein (HDL) Fraction | Cholesterol at Week 8 | -3.24 Percent of Change | Standard Deviation 9.567 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in High-density Lipoprotein (HDL) Fraction | Phospholipid at Week 4 | -6.47 Percent of Change | Standard Deviation 7.169 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in High-density Lipoprotein (HDL) Fraction | Phospholipid at Week 8 | -6.45 Percent of Change | Standard Deviation 10.432 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in High-density Lipoprotein (HDL) Fraction | Triglycerides at Week 8 | -6.99 Percent of Change | Standard Deviation 34.397 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in High-density Lipoprotein (HDL) Fraction | Phospholipid at Week 8 | -3.40 Percent of Change | Standard Deviation 10.212 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in High-density Lipoprotein (HDL) Fraction | Cholesterol at Week 4 | 0.64 Percent of Change | Standard Deviation 8.039 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in High-density Lipoprotein (HDL) Fraction | Cholesterol at Week 8 | 1.48 Percent of Change | Standard Deviation 8.249 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in High-density Lipoprotein (HDL) Fraction | Triglycerides at Week 4 | 6.20 Percent of Change | Standard Deviation 23.726 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in High-density Lipoprotein (HDL) Fraction | Triglycerides at Week 8 | 0.91 Percent of Change | Standard Deviation 19.979 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in High-density Lipoprotein (HDL) Fraction | Free Cholesterol at Week 4 | 3.29 Percent of Change | Standard Deviation 9.708 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in High-density Lipoprotein (HDL) Fraction | Free Cholesterol at Week 8 | 5.61 Percent of Change | Standard Deviation 12.174 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in High-density Lipoprotein (HDL) Fraction | Phospholipid at Week 4 | -2.32 Percent of Change | Standard Deviation 8.029 |
Secondary
Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Low-density Lipoprotein (LDL) Fraction
Major 4 lipid constituents refer to cholesterol, triglycerides, free cholesterol, and phospholipid. The reported data are percent of change from baseline in concentration of the each lipid constituents in LDL Fraction at Week 4 and Week 8.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Low-density Lipoprotein (LDL) Fraction | Cholesterol at Week 4 | -4.40 Percent of Change | Standard Deviation 10.3 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Low-density Lipoprotein (LDL) Fraction | Cholesterol at Week 8 | -6.25 Percent of Change | Standard Deviation 12.087 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Low-density Lipoprotein (LDL) Fraction | Triglycerides at Week 4 | 0.38 Percent of Change | Standard Deviation 13.307 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Low-density Lipoprotein (LDL) Fraction | Triglycerides at Week 8 | -2.28 Percent of Change | Standard Deviation 15.034 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Low-density Lipoprotein (LDL) Fraction | Free Cholesterol at Week 4 | -0.37 Percent of Change | Standard Deviation 12.581 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Low-density Lipoprotein (LDL) Fraction | Free Cholesterol at Week 8 | -0.48 Percent of Change | Standard Deviation 15.395 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Low-density Lipoprotein (LDL) Fraction | Phospholipid at Week 4 | -3.94 Percent of Change | Standard Deviation 8.257 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Low-density Lipoprotein (LDL) Fraction | Phospholipid at Week 8 | -4.80 Percent of Change | Standard Deviation 10.561 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Low-density Lipoprotein (LDL) Fraction | Phospholipid at Week 8 | 1.58 Percent of Change | Standard Deviation 9.817 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Low-density Lipoprotein (LDL) Fraction | Cholesterol at Week 4 | 1.44 Percent of Change | Standard Deviation 11.146 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Low-density Lipoprotein (LDL) Fraction | Free Cholesterol at Week 4 | 0.30 Percent of Change | Standard Deviation 13.908 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Low-density Lipoprotein (LDL) Fraction | Cholesterol at Week 8 | 3.45 Percent of Change | Standard Deviation 11.789 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Low-density Lipoprotein (LDL) Fraction | Phospholipid at Week 4 | 0.29 Percent of Change | Standard Deviation 9.809 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Low-density Lipoprotein (LDL) Fraction | Triglycerides at Week 4 | 3.82 Percent of Change | Standard Deviation 10.813 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Low-density Lipoprotein (LDL) Fraction | Free Cholesterol at Week 8 | 3.32 Percent of Change | Standard Deviation 12.404 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Low-density Lipoprotein (LDL) Fraction | Triglycerides at Week 8 | 2.19 Percent of Change | Standard Deviation 12.348 |
Secondary
Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Very Low-density Lipoprotein (VLDL) Fraction
Major 4 lipid constituents refer to cholesterol, triglycerides, free cholesterol, and phospholipid. The reported data are percent of change from baseline in concentration of the each lipid constituents in VLDL Fraction at Week 4 and Week 8.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Very Low-density Lipoprotein (VLDL) Fraction | Cholesterol at Week 4 | -10.45 Percent of Change | Standard Deviation 17.089 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Very Low-density Lipoprotein (VLDL) Fraction | Cholesterol at Week 8 | -15.16 Percent of Change | Standard Deviation 19.449 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Very Low-density Lipoprotein (VLDL) Fraction | Triglycerides at Week 4 | -15.21 Percent of Change | Standard Deviation 23.536 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Very Low-density Lipoprotein (VLDL) Fraction | Triglycerides at Week 8 | -17.26 Percent of Change | Standard Deviation 24.705 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Very Low-density Lipoprotein (VLDL) Fraction | Free Cholesterol at Week 4 | -13.06 Percent of Change | Standard Deviation 19.539 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Very Low-density Lipoprotein (VLDL) Fraction | Free Cholesterol at Week 8 | -16.48 Percent of Change | Standard Deviation 24.694 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Very Low-density Lipoprotein (VLDL) Fraction | Phospholipid at Week 4 | -13.78 Percent of Change | Standard Deviation 19.839 |
| TAK-085 4 g | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Very Low-density Lipoprotein (VLDL) Fraction | Phospholipid at Week 8 | -16.49 Percent of Change | Standard Deviation 22.717 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Very Low-density Lipoprotein (VLDL) Fraction | Phospholipid at Week 8 | -1.09 Percent of Change | Standard Deviation 16.446 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Very Low-density Lipoprotein (VLDL) Fraction | Cholesterol at Week 4 | 5.45 Percent of Change | Standard Deviation 15.255 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Very Low-density Lipoprotein (VLDL) Fraction | Free Cholesterol at Week 4 | 6.99 Percent of Change | Standard Deviation 20.379 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Very Low-density Lipoprotein (VLDL) Fraction | Cholesterol at Week 8 | 1.03 Percent of Change | Standard Deviation 14.717 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Very Low-density Lipoprotein (VLDL) Fraction | Phospholipid at Week 4 | 5.99 Percent of Change | Standard Deviation 19.193 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Very Low-density Lipoprotein (VLDL) Fraction | Triglycerides at Week 4 | 7.24 Percent of Change | Standard Deviation 28.285 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Very Low-density Lipoprotein (VLDL) Fraction | Free Cholesterol at Week 8 | 0.64 Percent of Change | Standard Deviation 17.034 |
| Control Group | Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Very Low-density Lipoprotein (VLDL) Fraction | Triglycerides at Week 8 | -1.32 Percent of Change | Standard Deviation 20.084 |
Secondary
Percent Changes From Baseline in Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio in Total Lipids
The reported data are percent of change from baseline in DHA/AA ratio in total lipids at Week 4 and Week 8.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 4 g | Percent Changes From Baseline in Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio in Total Lipids | Week 4 | 57.80 Percent of Change | Standard Deviation 31.135 |
| TAK-085 4 g | Percent Changes From Baseline in Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio in Total Lipids | Week 8 | 66.11 Percent of Change | Standard Deviation 43.927 |
| Control Group | Percent Changes From Baseline in Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio in Total Lipids | Week 4 | 6.22 Percent of Change | Standard Deviation 22.634 |
| Control Group | Percent Changes From Baseline in Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio in Total Lipids | Week 8 | 10.29 Percent of Change | Standard Deviation 25.525 |
Secondary
Percent Changes From Baseline in Eicosapentaenoic Acid Plus Docosahexaenoic Acid to Arachidonic Acid (EPA+DHA/AA) Ratio in Total Lipids
The reported data are percent of change from baseline in EPA+DHA/AA ratio in total lipids at Week 4 and Week 8.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 4 g | Percent Changes From Baseline in Eicosapentaenoic Acid Plus Docosahexaenoic Acid to Arachidonic Acid (EPA+DHA/AA) Ratio in Total Lipids | Week 4 | 118.68 Percent of Change | Standard Deviation 57.033 |
| TAK-085 4 g | Percent Changes From Baseline in Eicosapentaenoic Acid Plus Docosahexaenoic Acid to Arachidonic Acid (EPA+DHA/AA) Ratio in Total Lipids | Week 8 | 132.20 Percent of Change | Standard Deviation 76.024 |
| Control Group | Percent Changes From Baseline in Eicosapentaenoic Acid Plus Docosahexaenoic Acid to Arachidonic Acid (EPA+DHA/AA) Ratio in Total Lipids | Week 4 | 8.87 Percent of Change | Standard Deviation 28.154 |
| Control Group | Percent Changes From Baseline in Eicosapentaenoic Acid Plus Docosahexaenoic Acid to Arachidonic Acid (EPA+DHA/AA) Ratio in Total Lipids | Week 8 | 14.29 Percent of Change | Standard Deviation 34.06 |
Secondary
Percent Changes From Baseline in Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio in Total Lipids
The reported data are percent of change from baseline in EPA/AA ratio in total lipids at Week 4 and Week 8.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 4 g | Percent Changes From Baseline in Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio in Total Lipids | Week 4 | 293.83 Percent of Change | Standard Deviation 185.305 |
| TAK-085 4 g | Percent Changes From Baseline in Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio in Total Lipids | Week 8 | 317.31 Percent of Change | Standard Deviation 212.306 |
| Control Group | Percent Changes From Baseline in Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio in Total Lipids | Week 4 | 18.98 Percent of Change | Standard Deviation 47.676 |
| Control Group | Percent Changes From Baseline in Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio in Total Lipids | Week 8 | 31.77 Percent of Change | Standard Deviation 75.839 |
Secondary
Percent Changes From Baseline in Eicosatrienoic Acid to Arachidonic Acid (T/T) Ratio in Total Lipids
The reported data are percent of change from baseline in T/T ratio in total lipids at Week 4 and Week 8.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-085 4 g | Percent Changes From Baseline in Eicosatrienoic Acid to Arachidonic Acid (T/T) Ratio in Total Lipids | Week 4 | -11.81 Percent of Change | Standard Deviation 23.814 |
| TAK-085 4 g | Percent Changes From Baseline in Eicosatrienoic Acid to Arachidonic Acid (T/T) Ratio in Total Lipids | Week 8 | -12.50 Percent of Change | Standard Deviation 22.656 |
| Control Group | Percent Changes From Baseline in Eicosatrienoic Acid to Arachidonic Acid (T/T) Ratio in Total Lipids | Week 4 | 8.62 Percent of Change | Standard Deviation 35.529 |
| Control Group | Percent Changes From Baseline in Eicosatrienoic Acid to Arachidonic Acid (T/T) Ratio in Total Lipids | Week 8 | 12.07 Percent of Change | Standard Deviation 43.62 |