Trial Outcomes & Findings for Exploratory Study of the Effects of Omega-3-acid Ethyl Esters on the Lipid and Lipoprotein Profile in the Blood (NCT NCT02839902)

Last Updated: 2019-02-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

53 participants

Primary outcome timeframe

Baseline, Week 4 and Week 8

Results posted on

2019-02-11

Participant Flow

Participants took part in the study at 7 investigative sites in Japan, from 27 December 2016 to 30 August 2017.

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).

Participant milestones

Participant milestones
Measure	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.	Control Group Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.
Overall Study STARTED	24	29
Overall Study COMPLETED	24	29
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TAK-085 4 g n=24 Participants 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.	Control Group n=29 Participants Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.	Total n=53 Participants Total of all reporting groups
Smoking Classification Never smoked	5 Participants n=24 Participants	9 Participants n=29 Participants	14 Participants n=53 Participants
Smoking Classification Current smoker	5 Participants n=24 Participants	7 Participants n=29 Participants	12 Participants n=53 Participants
Smoking Classification Ex-smoker	14 Participants n=24 Participants	13 Participants n=29 Participants	27 Participants n=53 Participants
Age, Continuous	60.5 Years STANDARD_DEVIATION 11.28 • n=24 Participants	62.3 Years STANDARD_DEVIATION 11.67 • n=29 Participants	61.5 Years STANDARD_DEVIATION 11.42 • n=53 Participants
Sex: Female, Male Female	1 Participants n=24 Participants	0 Participants n=29 Participants	1 Participants n=53 Participants
Sex: Female, Male Male	23 Participants n=24 Participants	29 Participants n=29 Participants	52 Participants n=53 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Japan	24 Participants n=24 Participants	29 Participants n=29 Participants	53 Participants n=53 Participants
Height	168.9 Centimeters (cm) STANDARD_DEVIATION 6.05 • n=24 Participants	167.7 Centimeters (cm) STANDARD_DEVIATION 7.55 • n=29 Participants	168.2 Centimeters (cm) STANDARD_DEVIATION 6.87 • n=53 Participants
Weight	77.93 Kilograms (kg) STANDARD_DEVIATION 9.784 • n=24 Participants	77.13 Kilograms (kg) STANDARD_DEVIATION 12.507 • n=29 Participants	77.49 Kilograms (kg) STANDARD_DEVIATION 11.257 • n=53 Participants
BMI	27.27 kg/m^2 STANDARD_DEVIATION 2.791 • n=24 Participants	27.39 kg/m^2 STANDARD_DEVIATION 3.746 • n=29 Participants	27.34 kg/m^2 STANDARD_DEVIATION 3.317 • n=53 Participants
Duration of Hyperlipemia	11.05 Years STANDARD_DEVIATION 7.590 • n=24 Participants	7.76 Years STANDARD_DEVIATION 5.847 • n=29 Participants	9.25 Years STANDARD_DEVIATION 6.828 • n=53 Participants
Frequency of Fish Intake Almost Every Day	2 Participants n=24 Participants	4 Participants n=29 Participants	6 Participants n=53 Participants
Frequency of Fish Intake About Every Two Days	6 Participants n=24 Participants	6 Participants n=29 Participants	12 Participants n=53 Participants
Frequency of Fish Intake About Once or Twice Per Week	15 Participants n=24 Participants	19 Participants n=29 Participants	34 Participants n=53 Participants
Frequency of Fish Intake Rarely	1 Participants n=24 Participants	0 Participants n=29 Participants	1 Participants n=53 Participants
Drinking habit Yes	7 Participants n=24 Participants	9 Participants n=29 Participants	16 Participants n=53 Participants
Drinking habit No	17 Participants n=24 Participants	20 Participants n=29 Participants	37 Participants n=53 Participants
Fasting Triglycerides	208.0 Milligram (mg)/deciliter (dL) STANDARD_DEVIATION 74.05 • n=24 Participants	214.7 Milligram (mg)/deciliter (dL) STANDARD_DEVIATION 73.12 • n=29 Participants	211.7 Milligram (mg)/deciliter (dL) STANDARD_DEVIATION 72.91 • n=53 Participants
Cholesterol Concentration in Small Dense Low Density Lipoprotein (sdLDL) Fraction	30.285 mg/dL STANDARD_DEVIATION 5.9109 • n=24 Participants	32.981 mg/dL STANDARD_DEVIATION 9.1346 • n=29 Participants	31.760 mg/dL STANDARD_DEVIATION 7.8879 • n=53 Participants
Triglycerides Concentration in sdLDL Fraction	6.778 mg/dL STANDARD_DEVIATION 1.8022 • n=24 Participants	7.320 mg/dL STANDARD_DEVIATION 2.0727 • n=29 Participants	7.074 mg/dL STANDARD_DEVIATION 1.9556 • n=53 Participants
Free Cholesterol Concentration in sdLDL Fraction	8.670 mg/dL STANDARD_DEVIATION 1.6883 • n=24 Participants	9.353 mg/dL STANDARD_DEVIATION 2.3705 • n=29 Participants	9.044 mg/dL STANDARD_DEVIATION 2.0986 • n=53 Participants
Phospholipid Concentration in sdLDL Fraction	31.526 mg/dL STANDARD_DEVIATION 5.1749 • n=24 Participants	33.860 mg/dL STANDARD_DEVIATION 7.9633 • n=29 Participants	32.803 mg/dL STANDARD_DEVIATION 6.8824 • n=53 Participants
Particle Size of LDL(Cholesterol Monitor)	25.712 Nanometer (nm) STANDARD_DEVIATION 0.4301 • n=24 Participants	25.681 Nanometer (nm) STANDARD_DEVIATION 0.4087 • n=29 Participants	25.695 Nanometer (nm) STANDARD_DEVIATION 0.4148 • n=53 Participants
Particle Size of LDL (Triglycerides Monitor)	29.378 nm STANDARD_DEVIATION 1.0152 • n=9 Participants • Population Analysis Description: The number analyzed is the number of participants with data available for analysis.	29.005 nm STANDARD_DEVIATION 0.8946 • n=11 Participants • Population Analysis Description: The number analyzed is the number of participants with data available for analysis.	29.173 nm STANDARD_DEVIATION 0.9442 • n=20 Participants • Population Analysis Description: The number analyzed is the number of participants with data available for analysis.
Particle Size of LDL (Free Cholesterol Monitor)	25.560 nm STANDARD_DEVIATION 0.4403 • n=24 Participants	25.492 nm STANDARD_DEVIATION 0.4263 • n=29 Participants	25.523 nm STANDARD_DEVIATION 0.4299 • n=53 Participants
Particle Size of LDL (Phospholipid Monitor)	25.335 nm STANDARD_DEVIATION 0.4431 • n=24 Participants	25.263 nm STANDARD_DEVIATION 0.3945 • n=29 Participants	25.296 nm STANDARD_DEVIATION 0.4147 • n=53 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	TAK-085 4 g n=24 Participants 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.	Control Group n=29 Participants Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.
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	2.74 Percent of Change Standard Deviation 20.317
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	5.05 Percent of Change Standard Deviation 11.401
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	4.64 Percent of Change Standard Deviation 17.845
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	9.71 Percent of Change Standard Deviation 23.437
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	2.14 Percent of Change Standard Deviation 14.048
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	3.42 Percent of Change Standard Deviation 14.516
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	2.10 Percent of Change Standard Deviation 11.297
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	1.09 Percent of Change Standard Deviation 13.440

PRIMARY outcome

Timeframe: 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.

Reported data are percent of change from baseline in in TG to cholesterol ratio in sdLDL fraction at Week 4 and Week 8.

Outcome measures

Outcome measures
Measure	TAK-085 4 g n=24 Participants 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.	Control Group n=29 Participants Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.
Percent Changes From Baseline in Triglycerides (TG) to Cholesterol Ratio in sdLDL Fraction Week 4	4.48 Percent of Change Standard Deviation 21.423	5.66 Percent of Change Standard Deviation 25.908
Percent Changes From Baseline in Triglycerides (TG) to Cholesterol Ratio in sdLDL Fraction Week 8	8.64 Percent of Change Standard Deviation 31.398	-0.94 Percent of Change Standard Deviation 17.267

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	TAK-085 4 g n=24 Participants 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.	Control Group n=29 Participants Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.
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	-0.39 Percent of Change Standard Deviation 0.820
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	-0.08 Percent of Change Standard Deviation 1.274
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	-0.06 Percent of Change Standard Deviation 1.367
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	0.52 Percent of Change Standard Deviation 3.155
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	-0.16 Percent of Change Standard Deviation 0.953
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	0.07 Percent of Change Standard Deviation 1.361
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	-0.23 Percent of Change Standard Deviation 1.018
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	0.09 Percent of Change Standard Deviation 1.431

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	TAK-085 4 g n=24 Participants 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.	Control Group n=29 Participants Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.
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	47.42 Percent of Change Standard Deviation 149.946
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 60.170	-0.68 Percent of Change Standard Deviation 65.088
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	42.62 Percent of Change Standard Deviation 132.804
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	-3.74 Percent of Change Standard Deviation 55.812
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 50.570	60.20 Percent of Change Standard Deviation 189.062
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	2.37 Percent of Change Standard Deviation 71.895
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	48.94 Percent of Change Standard Deviation 118.843
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 64.130	1.15 Percent of Change Standard Deviation 92.004

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	TAK-085 4 g n=24 Participants 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.	Control Group n=29 Participants Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.
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	5.45 Percent of Change Standard Deviation 15.255
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	1.03 Percent of Change Standard Deviation 14.717
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	7.24 Percent of Change Standard Deviation 28.285
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	-1.32 Percent of Change Standard Deviation 20.084
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	6.99 Percent of Change Standard Deviation 20.379
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	0.64 Percent of Change Standard Deviation 17.034
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	5.99 Percent of Change Standard Deviation 19.193
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	-1.09 Percent of Change Standard Deviation 16.446

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	TAK-085 4 g n=24 Participants 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.	Control Group n=29 Participants Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.
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 10.300	1.44 Percent of Change Standard Deviation 11.146
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	3.45 Percent of Change Standard Deviation 11.789
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	3.82 Percent of Change Standard Deviation 10.813
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	2.19 Percent of Change Standard Deviation 12.348
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	0.30 Percent of Change Standard Deviation 13.908
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	3.32 Percent of Change Standard Deviation 12.404
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	0.29 Percent of Change Standard Deviation 9.809
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	1.58 Percent of Change Standard Deviation 9.817

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	TAK-085 4 g n=24 Participants 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.	Control Group n=29 Participants Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.
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	-3.40 Percent of Change Standard Deviation 10.212
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	0.64 Percent of Change Standard Deviation 8.039
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	1.48 Percent of Change Standard Deviation 8.249
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	6.20 Percent of Change Standard Deviation 23.726
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	0.91 Percent of Change Standard Deviation 19.979
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	3.29 Percent of Change Standard Deviation 9.708
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	5.61 Percent of Change Standard Deviation 12.174
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	-2.32 Percent of Change Standard Deviation 8.029

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	TAK-085 4 g n=24 Participants 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.	Control Group n=29 Participants Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.
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	5.96 Percent of Change Standard Deviation 32.534
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	-4.90 Percent of Change Standard Deviation 15.856
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	17.71 Percent of Change Standard Deviation 68.061
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	-2.37 Percent of Change Standard Deviation 13.220
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	-0.72 Percent of Change Standard Deviation 36.672
Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids Erucic Acid at Week 8	-18.05 Percent of Change Standard Deviation 71.360	139.93 Percent of Change Standard Deviation 376.748
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	-2.00 Percent of Change Standard Deviation 20.004
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	-2.33 Percent of Change Standard Deviation 24.698
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	3.10 Percent of Change Standard Deviation 20.643
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	7.32 Percent of Change Standard Deviation 27.833
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	5.98 Percent of Change Standard Deviation 25.020
Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids Nervonic Acid Week 8	-7.82 Percent of Change Standard Deviation 15.480	13.04 Percent of Change Standard Deviation 29.043
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	50.65 Percent of Change Standard Deviation 86.467
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	34.60 Percent of Change Standard Deviation 138.684
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	24.68 Percent of Change Standard Deviation 54.142
Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids Myristoleic Acid at Week 4	-31.40 Percent of Change Standard Deviation 25.830	32.50 Percent of Change Standard Deviation 77.309
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	-0.55 Percent of Change Standard Deviation 37.180
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	5.77 Percent of Change Standard Deviation 17.277
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	-2.63 Percent of Change Standard Deviation 15.549
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	5.53 Percent of Change Standard Deviation 29.987
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	-1.17 Percent of Change Standard Deviation 22.775
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	4.03 Percent of Change Standard Deviation 16.408
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	0.12 Percent of Change Standard Deviation 14.957
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	3.28 Percent of Change Standard Deviation 19.641
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	2.93 Percent of Change Standard Deviation 12.616
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	-0.33 Percent of Change Standard Deviation 14.748
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	7.82 Percent of Change Standard Deviation 35.906
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 19.170	-1.63 Percent of Change Standard Deviation 23.426
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	12.09 Percent of Change Standard Deviation 34.208
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	-0.50 Percent of Change Standard Deviation 25.026
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	8.20 Percent of Change Standard Deviation 35.594
Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids Arachic Acid at Week 8	-7.11 Percent of Change Standard Deviation 43.510	2.01 Percent of Change Standard Deviation 32.969
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	6.82 Percent of Change Standard Deviation 41.150
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	0.80 Percent of Change Standard Deviation 27.505
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	0.31 Percent of Change Standard Deviation 14.078
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	-3.17 Percent of Change Standard Deviation 18.978
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	13.24 Percent of Change Standard Deviation 38.481
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	0.89 Percent of Change Standard Deviation 17.847
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	1.98 Percent of Change Standard Deviation 22.295
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	-1.97 Percent of Change Standard Deviation 13.223
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	16.58 Percent of Change Standard Deviation 53.986
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	29.05 Percent of Change Standard Deviation 83.267
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	4.09 Percent of Change Standard Deviation 39.343
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	91.40 Percent of Change Standard Deviation 214.836
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	4.94 Percent of Change Standard Deviation 23.847
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	1.07 Percent of Change Standard Deviation 21.927
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	5.83 Percent of Change Standard Deviation 22.423
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	5.78 Percent of Change Standard Deviation 25.442

SECONDARY outcome

Timeframe: 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 reported data are percent of change from baseline in T/T ratio in total lipids at Week 4 and Week 8.

Outcome measures

Outcome measures
Measure	TAK-085 4 g n=24 Participants 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.	Control Group n=29 Participants Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.
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	8.62 Percent of Change Standard Deviation 35.529
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	12.07 Percent of Change Standard Deviation 43.620

SECONDARY outcome

Timeframe: 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 reported data are percent of change from baseline in EPA/AA ratio in total lipids at Week 4 and Week 8.

Outcome measures

Outcome measures
Measure	TAK-085 4 g n=24 Participants 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.	Control Group n=29 Participants Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.
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	18.98 Percent of Change Standard Deviation 47.676
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	31.77 Percent of Change Standard Deviation 75.839

SECONDARY outcome

Timeframe: 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 reported data are percent of change from baseline in EPA+DHA/AA ratio in total lipids at Week 4 and Week 8.

Outcome measures

Outcome measures
Measure	TAK-085 4 g n=24 Participants 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.	Control Group n=29 Participants Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.
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	8.87 Percent of Change Standard Deviation 28.154
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	14.29 Percent of Change Standard Deviation 34.060

SECONDARY outcome

Timeframe: 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 reported data are percent of change from baseline in DHA/AA ratio in total lipids at Week 4 and Week 8.

Outcome measures

Outcome measures
Measure	TAK-085 4 g n=24 Participants 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.	Control Group n=29 Participants Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.
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	6.22 Percent of Change Standard Deviation 22.634
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	10.29 Percent of Change Standard Deviation 25.525

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	TAK-085 4 g n=24 Participants 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.	Control Group n=29 Participants Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.
Percent Change From Baseline in Concentration of Lipids in the Blood Total Cholesterol at Week 4	-5.74 Percent of Change Standard Deviation 7.680	2.07 Percent of Change Standard Deviation 8.336
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	1.43 Percent of Change Standard Deviation 8.267
Percent Change From Baseline in Concentration of Lipids in the Blood TG at Week 4	-16.57 Percent of Change Standard Deviation 27.101	9.60 Percent of Change Standard Deviation 34.407
Percent Change From Baseline in Concentration of Lipids in the Blood TG at Week 8	-14.51 Percent of Change Standard Deviation 32.860	-2.49 Percent of Change Standard Deviation 22.313
Percent Change From Baseline in Concentration of Lipids in the Blood HDL-C (Direct) at Week 4	-0.36 Percent of Change Standard Deviation 8.290	0.70 Percent of Change Standard Deviation 9.386
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	1.16 Percent of Change Standard Deviation 8.305
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	2.65 Percent of Change Standard Deviation 9.978
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	2.07 Percent of Change Standard Deviation 10.898
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	15.84 Percent of Change Standard Deviation 47.272
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	-4.89 Percent of Change Standard Deviation 27.442

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	TAK-085 4 g n=24 Participants 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.	Control Group n=29 Participants Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.
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	1.39 Percent of Change Standard Deviation 5.226
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	0.30 Percent of Change Standard Deviation 6.540
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	2.72 Percent of Change Standard Deviation 7.886
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	2.86 Percent of Change Standard Deviation 8.773
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	2.14 Percent of Change Standard Deviation 8.674
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	1.63 Percent of Change Standard Deviation 8.054
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	39.56 Percent of Change Standard Deviation 84.921
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	28.49 Percent of Change Standard Deviation 71.554
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	0.79 Percent of Change Standard Deviation 9.067
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	2.39 Percent of Change Standard Deviation 14.516
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	8.07 Percent of Change Standard Deviation 16.006
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	6.04 Percent of Change Standard Deviation 21.676
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	7.57 Percent of Change Standard Deviation 15.115
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	3.01 Percent of Change Standard Deviation 16.661
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	1.58 Percent of Change Standard Deviation 18.066
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	3.36 Percent of Change Standard Deviation 16.356
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	4.38 Percent of Change Standard Deviation 15.518
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	0.30 Percent of Change Standard Deviation 13.578

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	TAK-085 4 g n=24 Participants 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.	Control Group n=29 Participants Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.
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	1.80 Percent of Change Standard Deviation 5.893
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	1.37 Percent of Change Standard Deviation 7.687
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	42.88 Percent of Change Standard Deviation 134.849
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	-3.70 Percent of Change Standard Deviation 56.198
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	5.29 Percent of Change Standard Deviation 14.765
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	2.37 Percent of Change Standard Deviation 13.808
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	2.39 Percent of Change Standard Deviation 9.059
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	3.07 Percent of Change Standard Deviation 11.430

Adverse Events

TAK-085 4 g

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	TAK-085 4 g n=24 participants at risk 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.	Control Group n=29 participants at risk Stable HMG-CoA reductase inhibitor regimen at a consistent dose only.
Infections and infestations Viral upper respiratory tract infection	8.3% 2/24 • Up to Week 8 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/29 • Up to Week 8 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Publication restrictions are in place

Restriction type: OTHER