Trial Outcomes & Findings for Exploratory Study of the Effect of Omega-3-acid Ethyl Esters (TAK-085) on Vascular Endothelial Function in Patients With Hyperlipidemia by Flow Mediated Dilation (NCT NCT02824432)

NCT ID: NCT02824432

Last Updated: 2019-05-06

Results Overview

FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 37 participants
• Primary outcome timeframe: Prior to meal at Baseline, Week 4, and Week 8
• Results posted on: 2019-05-06

Participant Flow

Participants took part in the study at 7 investigative sites in Japan, from 04 August 2016 to 19 August 2017.

Participants with a historical diagnosis of hyperlipidemia were enrolled in one of two groups, omega-3-acid ethyl esters (TAK-085) 2 grams (g) and TAK-085 4 g treatment groups.

Participant milestones

Measure	TAK-085 2 g A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Overall Study STARTED	18	19
Overall Study COMPLETED	17	19
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	TAK-085 2 g A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Overall Study Major Protocol Deviation	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.	Total n=37 Participants Total of all reporting groups
Age, Continuous	58.5 Years STANDARD_DEVIATION 11.14 • n=18 Participants	61.5 Years STANDARD_DEVIATION 7.94 • n=19 Participants	60.1 Years STANDARD_DEVIATION 9.61 • n=37 Participants
Sex: Female, Male Female	11 Participants n=18 Participants	11 Participants n=19 Participants	22 Participants n=37 Participants
Sex: Female, Male Male	7 Participants n=18 Participants	8 Participants n=19 Participants	15 Participants n=37 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Japan	18 Participants n=18 Participants	19 Participants n=19 Participants	37 Participants n=37 Participants
Height	158.4 Centimeters (cm) STANDARD_DEVIATION 9.08 • n=18 Participants	162.1 Centimeters (cm) STANDARD_DEVIATION 9.21 • n=19 Participants	160.3 Centimeters (cm) STANDARD_DEVIATION 9.21 • n=37 Participants
Weight	68.34 Kilograms (kg) STANDARD_DEVIATION 13.288 • n=18 Participants	71.94 Kilograms (kg) STANDARD_DEVIATION 14.636 • n=19 Participants	70.19 Kilograms (kg) STANDARD_DEVIATION 13.921 • n=37 Participants
BMI	27.12 kg/m^2 STANDARD_DEVIATION 4.097 • n=18 Participants	27.14 kg/m^2 STANDARD_DEVIATION 3.483 • n=19 Participants	27.13 kg/m^2 STANDARD_DEVIATION 3.740 • n=37 Participants
Duration of Dyslipidemia	9.24 Years STANDARD_DEVIATION 5.924 • n=18 Participants	9.51 Years STANDARD_DEVIATION 5.173 • n=19 Participants	9.38 Years STANDARD_DEVIATION 5.474 • n=37 Participants
Postmenopausal Period	9.9 Years STANDARD_DEVIATION 6.11 • n=9 Participants • This baseline characteristic was analyzed only in female participants with available data for analysis.	16.6 Years STANDARD_DEVIATION 5.88 • n=8 Participants • This baseline characteristic was analyzed only in female participants with available data for analysis.	13.1 Years STANDARD_DEVIATION 6.77 • n=17 Participants • This baseline characteristic was analyzed only in female participants with available data for analysis.
Frequency of Consumption of Fish Almost Every Day	1 Participants n=18 Participants	1 Participants n=19 Participants	2 Participants n=37 Participants
Frequency of Consumption of Fish About Every 2 days	5 Participants n=18 Participants	2 Participants n=19 Participants	7 Participants n=37 Participants
Frequency of Consumption of Fish About Once or Twice per Week	11 Participants n=18 Participants	12 Participants n=19 Participants	23 Participants n=37 Participants
Frequency of Consumption of Fish Rarely	1 Participants n=18 Participants	4 Participants n=19 Participants	5 Participants n=37 Participants
Smoking History Never Smoked	13 Participants n=18 Participants	9 Participants n=19 Participants	22 Participants n=37 Participants
Smoking History Ex-Smoker	5 Participants n=18 Participants	10 Participants n=19 Participants	15 Participants n=37 Participants
Drinking History Yes	4 Participants n=18 Participants	2 Participants n=19 Participants	6 Participants n=37 Participants
Drinking History No	14 Participants n=18 Participants	17 Participants n=19 Participants	31 Participants n=37 Participants
Triglyceride (TG) level (fasting)	176.8 Milligram (mg)/deciliter (dL) STANDARD_DEVIATION 59.18 • n=18 Participants	194.4 Milligram (mg)/deciliter (dL) STANDARD_DEVIATION 48.57 • n=19 Participants	185.8 Milligram (mg)/deciliter (dL) STANDARD_DEVIATION 53.96 • n=37 Participants
TG level (4 h postprandial)	265.9 mg/dL STANDARD_DEVIATION 102.63 • n=18 Participants	278.2 mg/dL STANDARD_DEVIATION 70.54 • n=19 Participants	272.2 mg/dL STANDARD_DEVIATION 86.60 • n=37 Participants
EPA/AA ratio	0.265 Ratio STANDARD_DEVIATION 0.1156 • n=18 Participants	0.240 Ratio STANDARD_DEVIATION 0.1551 • n=19 Participants	0.252 Ratio STANDARD_DEVIATION 0.1360 • n=37 Participants

PRIMARY outcome

Timeframe: Prior to meal at Baseline, Week 4, and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Flow-mediated Dilation (FMD) With Fasting State at Baseline, Week 4 and Week 8 Baseline	6.71 Percentage of dilation Standard Deviation 3.466	5.85 Percentage of dilation Standard Deviation 3.615
Flow-mediated Dilation (FMD) With Fasting State at Baseline, Week 4 and Week 8 Week 4	5.85 Percentage of dilation Standard Deviation 1.920	3.15 Percentage of dilation Standard Deviation 2.898
Flow-mediated Dilation (FMD) With Fasting State at Baseline, Week 4 and Week 8 Week 8	5.38 Percentage of dilation Standard Deviation 2.279	3.95 Percentage of dilation Standard Deviation 2.244

PRIMARY outcome

Timeframe: Prior to meal at Baseline and Week 4, and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Change From Baseline in FMD With Fasting State at Week 4 and Week 8 Week 4	-1.02 Percentage of dilation Standard Deviation 2.782	-2.71 Percentage of dilation Standard Deviation 3.480
Change From Baseline in FMD With Fasting State at Week 4 and Week 8 Week 8	-1.20 Percentage of dilation Standard Deviation 3.638	-1.33 Percentage of dilation Standard Deviation 2.754

PRIMARY outcome

Timeframe: Prior to meal at Baseline and Week 4, and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Percent Change From Baseline in FMD With Fasting State at Baseline, Week 4 and Week 8 Week 4	24.01 Percent of Change Standard Deviation 143.217	-36.70 Percent of Change Standard Deviation 52.824
Percent Change From Baseline in FMD With Fasting State at Baseline, Week 4 and Week 8 Week 8	37.37 Percent of Change Standard Deviation 218.483	-8.19 Percent of Change Standard Deviation 52.111

SECONDARY outcome

Timeframe: 4-hours after meal at Baseline and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
FMD With 4-Hours Postprandial State at Baseline and Week 8 Baseline	5.49 Percentage of dilation Standard Deviation 2.489	3.80 Percentage of dilation Standard Deviation 2.267
FMD With 4-Hours Postprandial State at Baseline and Week 8 Week 8	5.81 Percentage of dilation Standard Deviation 2.848	4.95 Percentage of dilation Standard Deviation 2.516

SECONDARY outcome

Timeframe: 4-hours after meal at Baseline and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.

Outcome measures

Measure	TAK-085 2 g n=13 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=15 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Change From Baseline in FMD With 4-Hours Postprandial State at Week 8	0.02 Percentage of dilation Standard Deviation 1.284	1.02 Percentage of dilation Standard Deviation 3.519

SECONDARY outcome

Timeframe: 4-hours after meal at Baseline and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.

Outcome measures

Measure	TAK-085 2 g n=13 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=15 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Percent Change From Baseline in FMD With 4-Hours Postprandial State at Week 8	-1.62 Percent of Change Standard Deviation 31.542	76.79 Percent of Change Standard Deviation 132.271

SECONDARY outcome

Timeframe: Prior to meal at Baseline, Week 4, and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Triglyceride (TG) Level With Fasting State at Baseline, Week 4, and Week 8 Baseline	176.8 mg/dL Standard Deviation 59.18	194.4 mg/dL Standard Deviation 48.57
Triglyceride (TG) Level With Fasting State at Baseline, Week 4, and Week 8 Week 4	178.2 mg/dL Standard Deviation 75.49	144.6 mg/dL Standard Deviation 39.36
Triglyceride (TG) Level With Fasting State at Baseline, Week 4, and Week 8 Week 8	157.2 mg/dL Standard Deviation 45.80	144.9 mg/dL Standard Deviation 43.05

SECONDARY outcome

Timeframe: Prior to meal at Baseline and Week 4, and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Change From Baseline in TG Level With Fasting State at Week 4 and Week 8 Week 8	-23.1 mg/dL Standard Deviation 48.40	-49.4 mg/dL Standard Deviation 46.68
Change From Baseline in TG Level With Fasting State at Week 4 and Week 8 Week 4	1.4 mg/dL Standard Deviation 69.58	-49.8 mg/dL Standard Deviation 35.67

SECONDARY outcome

Timeframe: Prior to meal at Baseline and Week 4, and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Percent Change From Baseline in TG Level With Fasting State at Week 4 and Week 8 Week 4	4.8 Percent of Change Standard Deviation 34.17	-24.5 Percent of Change Standard Deviation 15.14
Percent Change From Baseline in TG Level With Fasting State at Week 4 and Week 8 Week 8	-7.7 Percent of Change Standard Deviation 31.26	-23.5 Percent of Change Standard Deviation 22.12

SECONDARY outcome

Timeframe: 4-hours after meal at Baseline, Week 4, and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
TG Level With 4-Hours Postprandial State at Baseline, Week 4 and Week 8 Baseline	265.9 mg/dL Standard Deviation 102.63	278.2 mg/dL Standard Deviation 70.54
TG Level With 4-Hours Postprandial State at Baseline, Week 4 and Week 8 Week 4	266.1 mg/dL Standard Deviation 75.18	216.2 mg/dL Standard Deviation 79.11
TG Level With 4-Hours Postprandial State at Baseline, Week 4 and Week 8 Week 8	240.5 mg/dL Standard Deviation 74.66	202.3 mg/dL Standard Deviation 78.26

SECONDARY outcome

Timeframe: 4-hours after meal at Baseline and Week 4, and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8 Week 4	-9.1 mg/dL Standard Deviation 89.29	-62.1 mg/dL Standard Deviation 54.28
Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8 Week 8	-34.7 mg/dL Standard Deviation 89.40	-75.9 mg/dL Standard Deviation 57.02

SECONDARY outcome

Timeframe: 4-hours after meal at Baseline and Week 4, and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Percent Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8 Week 4	3.8 Percent of Change Standard Deviation 29.15	-22.4 Percent of Change Standard Deviation 18.54
Percent Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8 Week 8	-6.0 Percent of Change Standard Deviation 35.29	-27.2 Percent of Change Standard Deviation 21.09

SECONDARY outcome

Timeframe: Prior to meal at Baseline, Week 4 and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Dihomo-gamma-linolenic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 Baseline	51.37 microgram (μg)/milliliter (mL) Standard Deviation 14.761	57.32 microgram (μg)/milliliter (mL) Standard Deviation 12.274
Dihomo-gamma-linolenic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 Week 4	42.54 microgram (μg)/milliliter (mL) Standard Deviation 11.493	34.37 microgram (μg)/milliliter (mL) Standard Deviation 7.777
Dihomo-gamma-linolenic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 Week 8	43.12 microgram (μg)/milliliter (mL) Standard Deviation 9.060	33.32 microgram (μg)/milliliter (mL) Standard Deviation 8.609

SECONDARY outcome

Timeframe: Prior to meal at Baseline and Week 4, and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Dihomo-gamma-linolenic acid at each time point.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at Week 4 and Week 8 Week 4	-8.83 μg/mL Standard Deviation 11.838	-22.95 μg/mL Standard Deviation 10.112
Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at Week 4 and Week 8 Week 8	-9.91 μg/mL Standard Deviation 9.338	-24.01 μg/mL Standard Deviation 10.093

SECONDARY outcome

Timeframe: Prior to meal at Baseline and Week 4, and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Dihomo-gamma-linolenic acid at each time point.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Percent Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at Week 4 and Week 8 Week 4	-12.99 Percent of Change Standard Deviation 23.659	-38.81 Percent of Change Standard Deviation 12.362
Percent Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at Week 4 and Week 8 Week 8	-15.11 Percent of Change Standard Deviation 20.541	-41.09 Percent of Change Standard Deviation 12.981

SECONDARY outcome

Timeframe: Prior to meal at Baseline, Week 4 and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Arachidonic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 Baseline	254.36 μg/mL Standard Deviation 52.266	253.08 μg/mL Standard Deviation 69.609
Arachidonic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 Week 4	238.69 μg/mL Standard Deviation 65.009	217.96 μg/mL Standard Deviation 49.583
Arachidonic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 Week 8	243.71 μg/mL Standard Deviation 76.318	197.82 μg/mL Standard Deviation 49.991

SECONDARY outcome

Timeframe: Prior to meal at Baseline and Week 4, and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Arachidonic acid at each time point.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Change From Baseline in Arachidonic Acid Concentration With Fasting State at Week 4 and Week 8 Week 4	-15.67 μg/mL Standard Deviation 32.588	-35.12 μg/mL Standard Deviation 37.533
Change From Baseline in Arachidonic Acid Concentration With Fasting State at Week 4 and Week 8 Week 8	-10.50 μg/mL Standard Deviation 39.241	-55.26 μg/mL Standard Deviation 36.603

SECONDARY outcome

Timeframe: Prior to meal at Baseline and Week 4, and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Arachidonic acid at each time point.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Percent Change From Baseline in Arachidonic Acid Concentration With Fasting State at Week 4 and Week 8 Week 4	-6.66 Percent of Change Standard Deviation 13.212	-11.80 Percent of Change Standard Deviation 12.789
Percent Change From Baseline in Arachidonic Acid Concentration With Fasting State at Week 4 and Week 8 Week 8	-5.41 Percent of Change Standard Deviation 15.195	-20.19 Percent of Change Standard Deviation 12.200

SECONDARY outcome

Timeframe: Prior to meal at Baseline, Week 4 and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Eicosapentaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 Baseline	66.04 μg/mL Standard Deviation 29.246	55.62 μg/mL Standard Deviation 26.992
Eicosapentaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 Week 4	128.07 μg/mL Standard Deviation 34.223	192.34 μg/mL Standard Deviation 43.711
Eicosapentaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 Week 8	134.94 μg/mL Standard Deviation 41.173	193.75 μg/mL Standard Deviation 45.718

SECONDARY outcome

Timeframe: Prior to meal at Baseline and Week 4, and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Eicosapentaenoic acid at each time point.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at Week 4 and Week 8 Week 4	62.02 μg/mL Standard Deviation 36.430	136.72 μg/mL Standard Deviation 45.047
Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at Week 4 and Week 8 Week 8	70.98 μg/mL Standard Deviation 32.197	138.13 μg/mL Standard Deviation 53.122

SECONDARY outcome

Timeframe: Prior to meal at Baseline and Week 4, and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Eicosapentaenoic acid at each time point.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Percent Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at Week 4 and Week 8 Week 4	126.17 Percent of Change Standard Deviation 85.878	297.49 Percent of Change Standard Deviation 140.921
Percent Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at Week 4 and Week 8 Week 8	137.55 Percent of Change Standard Deviation 94.717	305.92 Percent of Change Standard Deviation 153.767

SECONDARY outcome

Timeframe: Prior to meal at Baseline, Week 4 and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Docosahexaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 Baseline	173.30 μg/mL Standard Deviation 51.854	145.43 μg/mL Standard Deviation 45.037
Docosahexaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 Week 4	207.04 μg/mL Standard Deviation 51.493	212.20 μg/mL Standard Deviation 47.226
Docosahexaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8 Week 8	201.04 μg/mL Standard Deviation 47.958	207.53 μg/mL Standard Deviation 48.728

SECONDARY outcome

Timeframe: Prior to meal at Baseline and Week 4, and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Docosahexaenoic acid at each time point.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at Week 4 and Week 8 Week 4	33.74 μg/mL Standard Deviation 42.605	66.77 μg/mL Standard Deviation 41.677
Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at Week 4 and Week 8 Week 8	26.31 μg/mL Standard Deviation 31.103	62.11 μg/mL Standard Deviation 51.694

SECONDARY outcome

Timeframe: Prior to meal at Baseline and Week 4, and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Docosahexaenoic acid at each time point.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Percent Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at Week 4 and Week 8 Week 4	24.32 Percent of Change Standard Deviation 29.608	52.83 Percent of Change Standard Deviation 35.072
Percent Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at Week 4 and Week 8 Week 8	19.69 Percent of Change Standard Deviation 26.183	51.54 Percent of Change Standard Deviation 44.898

SECONDARY outcome

Timeframe: Prior to meal at Baseline, Week 4 and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8 Baseline	0.265 Ratio Standard Deviation 0.1156	0.240 Ratio Standard Deviation 0.1551
Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8 Week 4	0.564 Ratio Standard Deviation 0.1990	0.946 Ratio Standard Deviation 0.3722
Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8 Week 8	0.579 Ratio Standard Deviation 0.1811	1.043 Ratio Standard Deviation 0.3881

SECONDARY outcome

Timeframe: Prior to meal at Baseline and Week 4, and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in EPA/AA Ratio at each time point.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Change From Baseline in EPA/AA Ratio With Fasting State at Week 4 and Week 8 Week 4	0.299 Ratio Standard Deviation 0.1714	0.706 Ratio Standard Deviation 0.2874
Change From Baseline in EPA/AA Ratio With Fasting State at Week 4 and Week 8 Week 8	0.322 Ratio Standard Deviation 0.1301	0.803 Ratio Standard Deviation 0.3241

SECONDARY outcome

Timeframe: Prior to meal at Baseline and Week 4, and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in EPA/AA Ratio at each time point.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Percent Change From Baseline in EPA/AA Ratio With Fasting State at Week 4 and Week 8 Week 4	141.396 Percent of Change Standard Deviation 94.4914	353.990 Percent of Change Standard Deviation 162.5131
Percent Change From Baseline in EPA/AA Ratio With Fasting State at Week 4 and Week 8 Week 8	152.244 Percent of Change Standard Deviation 95.3802	412.899 Percent of Change Standard Deviation 202.3624

SECONDARY outcome

Timeframe: Prior to meal at Baseline, Week 4 and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8 Week 8	0.881 Ratio Standard Deviation 0.2673	1.119 Ratio Standard Deviation 0.4178
Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8 Baseline	0.697 Ratio Standard Deviation 0.2163	0.619 Ratio Standard Deviation 0.2795
Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8 Week 4	0.913 Ratio Standard Deviation 0.2874	1.038 Ratio Standard Deviation 0.3726

SECONDARY outcome

Timeframe: Prior to meal at Baseline and Week 4, and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in DHA/AA ratio at each time point.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Change From Baseline in DHA/AA Ratio With Fasting State at Week 4 and Week 8 Week 4	0.216 Ratio Standard Deviation 0.1782	0.419 Ratio Standard Deviation 0.2170
Change From Baseline in DHA/AA Ratio With Fasting State at Week 4 and Week 8 Week 8	0.177 Ratio Standard Deviation 0.1512	0.499 Ratio Standard Deviation 0.3002

SECONDARY outcome

Timeframe: Prior to meal at Baseline and Week 4, and Week 8

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in DHA/AA ratio at each time point.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Percent Change From Baseline in DHA/AA Ratio With Fasting State at Week 4 and Week 8 Week 4	33.538 Percent of Change Standard Deviation 27.8356	76.932 Percent of Change Standard Deviation 52.6408
Percent Change From Baseline in DHA/AA Ratio With Fasting State at Week 4 and Week 8 Week 8	27.797 Percent of Change Standard Deviation 26.0796	93.582 Percent of Change Standard Deviation 69.6390

SECONDARY outcome

Timeframe: Up to Week 8

Population: Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Number of Participants Reporting One or More Adverse Events (AEs)	4 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to Week 8

Population: Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Number of Participants Reporting One or More AEs Related to Body Weight	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 8

Population: Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Number of Participants Reporting One or More AEs Related to Blood Pressure in the Sitting Position	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 8

Population: Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Number of Participants Reporting One or More AEs Related to Pulse in the Sitting Position	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 8

Population: Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study.

Outcome measures

Measure	TAK-085 2 g n=18 Participants A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 Participants A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Number of Participants Reporting One or More AEs Related to Laboratory Tests of Fasting Plasma Glucose	0 Participants	0 Participants

Adverse Events

TAK-085 2 g

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

TAK-085 4 g

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	TAK-085 2 g n=18 participants at risk A dose of 2 g of omega-3-acid ethyl esters (TAK-085) was orally administered once a day immediately after meal.	TAK-085 4 g n=19 participants at risk A dose of 4 g of omega-3-acid ethyl esters (TAK-085) was orally administered twice a day immediately after meal.
Gastrointestinal disorders Constipation	5.6% 1/18 • 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% 0/19 • 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.
Gastrointestinal disorders Diarrhoea	5.6% 1/18 • 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% 0/19 • 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.
Gastrointestinal disorders Vomiting	5.6% 1/18 • 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% 0/19 • 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.
Infections and infestations Pharyngitis	0.00% 0/18 • 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.	5.3% 1/19 • 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.
Infections and infestations Upper respiratory tract infection	5.6% 1/18 • 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% 0/19 • 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.
Infections and infestations Viral upper respiratory tract infection	5.6% 1/18 • 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% 0/19 • 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.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/18 • 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.	5.3% 1/19 • 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: trialdisclosures@takeda.com

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