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Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Normal Renal Function (NCT NCT03001817)

NCT ID: NCT03001817

Last Updated: 2022-11-30

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

551 participants

Primary outcome timeframe

12 Weeks

Results posted on

2022-11-30

Participant Flow

Eligible participants entered a 4- to 6-week lifestyle stabilization period followed by a 2-week TG qualifying period, used to determine eligibility for the study. After confirmation of qualifying fasting TG values, eligible participants entered a 12-week Efficacy Period. Participants who successfully completed the 12-week Efficacy Period were eligible to continue in a 40-week Extension Period.

Participant milestones

Participant milestones
Measure
K-877
Participants randomized to receive K-877 0.2 mg tablets twice daily in the 12-week Efficacy Period continued to receive K-877 0.2 mg tablets twice daily (BID) as well as placebo matching fenofibrate tablets once daily, in the 40-week Extension Period
Placebo/Fenofibrate
Participants randomized to receive placebo matching K-877 0.2 mg tablets BID in the 12-week Efficacy Period received fenofibrate 145 mg tablet once daily and placebo matching K-877 0.2 mg tablet BID in the 40-week Extension Period.
12 Week Efficacy
STARTED
368
183
12 Week Efficacy
COMPLETED
356
179
12 Week Efficacy
NOT COMPLETED
12
4
40 Week Extension
STARTED
350
177
40 Week Extension
COMPLETED
335
163
40 Week Extension
NOT COMPLETED
15
14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Normal Renal Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
K-877
n=368 Participants
Participants randomized to receive K-877 0.2 mg BID in the 12-week Efficacy Period continued to receive K-877 0.2 mg BID, as well as placebo matching fenofibrate 145 mg once daily, in the 40-week Extension Period.
Placebo/Fenofibrate
n=183 Participants
Participants randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period received fenofibrate 145 mg once daily and placebo matching K-877 0.2 mg BID in the 40-week Extension Period.
Total
n=551 Participants
Total of all reporting groups
Age, Customized
Age (Years) · <65
351 Participants
n=99 Participants
176 Participants
n=107 Participants
527 Participants
n=206 Participants
Age, Customized
Age (Years) · ≥65
17 Participants
n=99 Participants
7 Participants
n=107 Participants
24 Participants
n=206 Participants
Sex: Female, Male
Female
97 Participants
n=99 Participants
39 Participants
n=107 Participants
136 Participants
n=206 Participants
Sex: Female, Male
Male
271 Participants
n=99 Participants
144 Participants
n=107 Participants
415 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
27 Participants
n=99 Participants
8 Participants
n=107 Participants
35 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
341 Participants
n=99 Participants
175 Participants
n=107 Participants
516 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
Asian
3 Participants
n=99 Participants
2 Participants
n=107 Participants
5 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants
n=99 Participants
0 Participants
n=107 Participants
2 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
4 Participants
n=99 Participants
0 Participants
n=107 Participants
4 Participants
n=206 Participants
Race (NIH/OMB)
White
358 Participants
n=99 Participants
180 Participants
n=107 Participants
538 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Triglycerides
810.98 mg/dL
STANDARD_DEVIATION 369.284 • n=99 Participants
819.25 mg/dL
STANDARD_DEVIATION 414.722 • n=107 Participants
813.73 mg/dL
STANDARD_DEVIATION 384.611 • n=206 Participants

PRIMARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change of Fasting Triglyceride(TG) Levels From Baseline to Week 12
-7.97 Percent of Change
Interval -44.78 to 49.87
-56.00 Percent of Change
Interval -72.08 to -32.4

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Remnant Cholesterol
-3.36 Percent Change
Interval -31.18 to 39.47
-52.95 Percent Change
Interval -67.97 to -27.64

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in HDL-C
4.00 Percent Change
Interval -8.91 to 15.58
16.25 Percent Change
Interval -1.13 to 40.15

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Apo A1
2.13 Percent Change
Interval -5.75 to 9.48
1.21 Percent Change
Interval -8.68 to 11.77

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Non-HDL-C
0.81 Percent Change
Interval -17.14 to 22.65
-16.07 Percent Change
Interval -31.98 to 0.73

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Total Cholesterol
1.55 Percent Change
Interval -13.17 to 19.84
-11.26 Percent Change
Interval -24.95 to 3.4

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in LDL-C
1.01 Percent Change
Interval -19.83 to 26.41
31.93 Percent Change
Interval 0.84 to 78.12

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=171 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=356 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Free Fatty Acids (FFAs)
10.29 Percent Chage
Interval -22.61 to 71.16
-19.07 Percent Chage
Interval -41.64 to 14.1

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Apo A2
2.89 Percent Change
Interval -5.99 to 9.71
15.30 Percent Change
Interval 0.32 to 27.06

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Apo B
3.73 Percent Change
Interval -9.09 to 17.51
2.41 Percent Change
Interval -12.71 to 19.36

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Apo B48
22.62 Percent Change
Interval -38.27 to 138.37
-31.35 Percent Change
Interval -64.59 to 33.65

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Apo B100
2.76 Percent Change
Interval -11.55 to 17.15
3.09 Percent Change
Interval -12.2 to 20.48

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Apo C2
0.00 Percent Change
Interval -0.03 to 0.0
0.00 Percent Change
Interval -25.01 to 0.0

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Apo C3
5.11 Percent Change
Interval -17.61 to 36.39
-39.56 Percent Change
Interval -54.84 to -16.27

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Apo E
0.56 Percent Change
Interval -18.21 to 37.2
-28.48 Percent Change
Interval -43.33 to -3.58

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Change From Baseline to Week 12 in Fibroblast Growth Factor 21 (FGF21)
3.88 pg/mL
Interval -100.26 to 121.23
196.97 pg/mL
Interval 37.42 to 469.14

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Change From Baseline to Week 12 in hsCRP
-0.100 mg/L
Interval -1.273 to 0.597
-0.051 mg/L
Interval -1.491 to 0.743

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Large
5.99 Percent Change
Interval -21.19 to 39.53
-27.89 Percent Change
Interval -51.25 to -0.45

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Intermediate
4.70 Percent Change
Interval -18.69 to 28.96
-17.32 Percent Change
Interval -37.38 to 5.09

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Small
1.86 Percent Change
Interval -18.4 to 24.46
-4.13 Percent Change
Interval -19.85 to 16.25

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Ion Mobility - Intermediate Density Lipoproteins 1
2.10 Percent Change
Interval -17.05 to 25.95
4.47 Percent Change
Interval -13.54 to 24.49

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Ion Mobility - Intermediate Density Lipoproteins 2
3.06 Percent Change
Interval -14.55 to 24.51
15.50 Percent Change
Interval -0.61 to 44.88

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins I
1.04 Percent Change
Interval -15.53 to 21.64
45.24 Percent Change
Interval 11.8 to 87.52

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIa
0.75 Percent Change
Interval -16.59 to 22.46
59.36 Percent Change
Interval 17.64 to 112.28

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIb
1.26 Percent Change
Interval -17.93 to 26.0
61.87 Percent Change
Interval 12.77 to 111.62

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIIa
0.85 Percent Change
Interval -14.11 to 33.65
33.08 Percent Change
Interval -10.18 to 85.81

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIIb
1.11 Percent Change
Interval -19.55 to 29.73
-1.50 Percent Change
Interval -41.65 to 52.99

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVa
-0.26 Percent Change
Interval -20.3 to 25.74
-24.88 Percent Change
Interval -56.93 to 7.48

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVb
5.60 Percent Change
Interval -19.62 to 32.04
-34.81 Percent Change
Interval -53.95 to -12.17

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVc
4.65 Percent Change
Interval -14.87 to 24.95
-21.68 Percent Change
Interval -39.22 to -4.57

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Ion Mobility - High Density Lipoproteins 2b
2.04 Percent Change
Interval -10.69 to 15.52
-7.34 Percent Change
Interval -19.8 to 3.85

SECONDARY outcome

Timeframe: 12 Weeks

Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction.

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Ion Mobility - High Density Lipoproteins 3 and 2a
1.76 Percent Change
Interval -9.43 to 11.91
-2.01 Percent Change
Interval -13.44 to 9.82

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Ion Mobility - Major LDL Particle Measurement
-0.06 Percent Change
Interval -0.97 to 0.84
2.38 Percent Change
Interval 0.74 to 4.31

SECONDARY outcome

Timeframe: 12 Weeks

Two types of lipoprotein particles were analyzed together as one measurement without distinction.

Outcome measures

Outcome measures
Measure
Placebo
n=182 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=367 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Particles
5.37 Percent Change
Interval -23.57 to 53.56
-37.93 Percent Change
Interval -60.09 to -7.54

SECONDARY outcome

Timeframe: 12 Weeks

Two types of lipoprotein particles were analyzed together as one measurement without distinction.

Outcome measures

Outcome measures
Measure
Placebo
n=182 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=367 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Particles-Large
7.54 Percent Change
Interval -35.11 to 103.86
-48.58 Percent Change
Interval -73.96 to -15.98

SECONDARY outcome

Timeframe: 12 Weeks

Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.

Outcome measures

Outcome measures
Measure
Placebo
n=182 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=367 Participants
K-877 0.2 mg tablet BID
Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particles-Medium
7.58 nmol/L
Interval -33.08 to 47.63
-33.57 nmol/L
Interval -72.83 to 0.59

SECONDARY outcome

Timeframe: 12 Weeks

Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.

Outcome measures

Outcome measures
Measure
Placebo
n=182 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=367 Participants
K-877 0.2 mg tablet BID
Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particles-Small
-1.87 nmol/L
Interval -23.39 to 12.26
0.90 nmol/L
Interval -13.53 to 18.1

SECONDARY outcome

Timeframe: 12 Weeks

Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.

Outcome measures

Outcome measures
Measure
Placebo
n=182 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=367 Participants
K-877 0.2 mg tablet BID
Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles (Total)
51.43 nmol/L
Interval -213.52 to 275.68
209.41 nmol/L
Interval -139.84 to 596.86

SECONDARY outcome

Timeframe: 12 Weeks

Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.

Outcome measures

Outcome measures
Measure
Placebo
n=182 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=367 Participants
K-877 0.2 mg tablet BID
Change From Baseline to Week 12 in Lipoprotein Fraction - Intermediate-density Lipoprotein (IDL) Particles
-0.21 nmol/L
Interval -98.28 to 102.41
-5.52 nmol/L
Interval -109.19 to 49.33

SECONDARY outcome

Timeframe: 12 Weeks

Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.

Outcome measures

Outcome measures
Measure
Placebo
n=182 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=367 Participants
K-877 0.2 mg tablet BID
Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles-Large
0.00 nmol/L
Interval 0.0 to 39.76
27.54 nmol/L
Interval 0.0 to 256.61

SECONDARY outcome

Timeframe: 12 Weeks

Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.

Outcome measures

Outcome measures
Measure
Placebo
n=182 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=367 Participants
K-877 0.2 mg tablet BID
Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles-Small
23.85 nmol/L
Interval -200.74 to 297.25
87.75 nmol/L
Interval -254.51 to 468.78

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=182 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=367 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles (Total)
-1.07 Percent Change
Interval -12.86 to 13.72
2.87 Percent Change
Interval -9.72 to 17.11

SECONDARY outcome

Timeframe: 12 Weeks

Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.

Outcome measures

Outcome measures
Measure
Placebo
n=182 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=367 Participants
K-877 0.2 mg tablet BID
Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Large
0.05 μmol/L
Interval -1.28 to 1.43
0.27 μmol/L
Interval -0.94 to 1.45

SECONDARY outcome

Timeframe: 12 Weeks

Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.

Outcome measures

Outcome measures
Measure
Placebo
n=182 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=367 Participants
K-877 0.2 mg tablet BID
Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Medium
0.02 μmol/L
Interval -3.32 to 2.74
-0.97 μmol/L
Interval -4.31 to 2.65

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=182 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=367 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Small
-2.42 Percent Change
Interval -18.72 to 17.47
7.08 Percent Change
Interval -14.34 to 32.08

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=182 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=367 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particle Size
0.80 Percent Change
Interval -10.18 to 12.05
-5.70 Percent Change
Interval -14.7 to 5.21

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=180 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=364 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particle Size
0.01 Percent Change
Interval -0.51 to 1.0
1.00 Percent Change
Interval 0.0 to 3.26

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=182 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=367 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particle Size
0.00 Percent Change
Interval -2.89 to 3.36
-1.14 Percent Change
Interval -4.44 to 2.07

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=182 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=367 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - Triglyceride (Total)
8.43 Percent Change
Interval -28.9 to 70.31
-48.78 Percent Change
Interval -69.8 to -18.51

SECONDARY outcome

Timeframe: 12 Weeks

Two types of lipoprotein particles were analyzed together as one measurement without distinction.

Outcome measures

Outcome measures
Measure
Placebo
n=182 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=367 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Triglyceride
6.71 Percent Change
Interval -28.59 to 70.18
-49.06 Percent Change
Interval -70.3 to -20.13

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=170 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=358 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Cholesterol
-4.63 Percent Change
Interval -18.43 to 13.68
-0.11 Percent Change
Interval -19.62 to 22.54

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TG:HDL-C
-11.22 Percent Change
Interval -49.07 to 57.86
-62.64 Percent Change
Interval -79.05 to -34.09

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Total Cholesterol (TC):HDL-C
-3.86 Percent Change
Interval -22.83 to 19.87
-25.84 Percent Change
Interval -42.29 to -4.77

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C
-4.49 Percent Change
Interval -25.49 to 23.46
-30.79 Percent Change
Interval -47.69 to -5.64

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B
-0.49 Percent Change
Interval -21.23 to 18.79
30.90 Percent Change
Interval 7.3 to 62.27

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo B:Apo A1
2.47 Percent Change
Interval -11.55 to 14.6
0.73 Percent Change
Interval -15.39 to 20.43

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=183 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=368 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2
7.50 Percent Change
Interval -13.29 to 35.11
-24.84 Percent Change
Interval -44.79 to -3.68

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=163 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=335 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Fasting TG
-55.45 Percent of Change
Interval -68.95 to -28.74
-57.93 Percent of Change
Interval -73.76 to -31.97

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=161 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=331 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Remnant Cholesterol
-49.11 Percent of Change
Interval -67.45 to -21.35
-53.98 Percent of Change
Interval -70.63 to -26.55

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=163 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=335 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in HDL-C
19.35 Percent of Change
Interval 3.03 to 38.89
17.65 Percent of Change
Interval -1.27 to 39.29

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=162 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=334 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Apo A1
3.48 Percent of Change
Interval -3.42 to 10.92
1.63 Percent of Change
Interval -8.59 to 10.42

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=163 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=335 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Non-HDL-C
-15.71 Percent of Change
Interval -29.85 to 0.63
-17.24 Percent of Change
Interval -32.0 to 0.0

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=163 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=335 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in TC
-9.93 Percent of Change
Interval -23.08 to 3.21
-11.84 Percent of Change
Interval -25.37 to 1.61

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=161 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=331 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in LDL-C
36.84 Percent of Change
Interval 1.38 to 78.29
31.15 Percent of Change
Interval 2.04 to 70.59

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=128 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=263 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in FFAs
-13.64 Percent of Change
Interval -38.15 to 13.91
-18.08 Percent of Change
Interval -40.81 to 18.6

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=162 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=333 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Apo A2
12.31 Percent of Change
Interval 0.0 to 22.58
9.26 Percent of Change
Interval -2.44 to 22.58

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=162 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=334 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Apo B
2.46 Percent of Change
Interval -12.68 to 17.0
0.93 Percent of Change
Interval -12.65 to 19.85

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=161 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=333 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Apo B48
-5.22 Percent of Change
Interval -48.4 to 84.46
-14.04 Percent of Change
Interval -56.9 to 68.32

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=161 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=333 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Apo B100
1.97 Percent of Change
Interval -12.66 to 17.23
1.48 Percent of Change
Interval -13.93 to 19.77

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=159 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=330 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Apo C2
-1.80 Percent of Change
Interval -24.2 to 0.0
-8.70 Percent of Change
Interval -30.6 to 0.0

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=160 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=332 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Apo C3
-30.77 Percent of Change
Interval -51.65 to -5.91
-36.70 Percent of Change
Interval -58.82 to -15.25

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=162 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=332 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Apo E
-30.67 Percent of Change
Interval -44.6 to -4.44
-29.94 Percent of Change
Interval -47.16 to -10.64

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=162 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=332 Participants
K-877 0.2 mg tablet BID
Change From Baseline to Week 52 in FGF21
207.50 pg/mL
Interval 53.7 to 499.9
259.20 pg/mL
Interval 16.1 to 545.65

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=162 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=333 Participants
K-877 0.2 mg tablet BID
Change From Baseline to Week 52 in hsCRP
-0.200 mg/L
Interval -1.32 to 0.4
0.000 mg/L
Interval -1.0 to 1.4

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=162 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=332 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Large
-24.44 Percent Change
Interval -46.64 to 4.31
-33.43 Percent Change
Interval -53.96 to 5.54

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=162 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=332 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Intermediate
-11.70 Percent Change
Interval -32.94 to 10.5
-21.71 Percent Change
Interval -40.18 to 11.94

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=162 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=332 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Small
-3.23 Percent Change
Interval -18.03 to 28.03
-4.28 Percent Change
Interval -22.23 to 17.29

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=162 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=332 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Ion Mobility - Intermediate Density Lipoproteins 1
8.23 Percent Change
Interval -15.88 to 37.67
4.44 Percent Change
Interval -12.86 to 25.81

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=162 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=332 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Ion Mobility - Intermediate Density Lipoproteins 2
21.09 Percent Change
Interval -4.0 to 51.0
21.05 Percent Change
Interval 2.32 to 48.91

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=162 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=332 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins I
38.99 Percent Change
Interval 9.07 to 82.58
48.52 Percent Change
Interval 17.51 to 95.7

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=162 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=332 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIa
44.52 Percent Change
Interval 8.87 to 113.47
64.54 Percent Change
Interval 21.24 to 120.44

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=162 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=332 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIb
42.18 Percent Change
Interval 8.41 to 102.42
58.07 Percent Change
Interval 14.25 to 122.86

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=162 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=332 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIIa
30.84 Percent Change
Interval -3.26 to 86.03
31.63 Percent Change
Interval -7.19 to 75.36

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=162 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=332 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIIb
4.31 Percent Change
Interval -23.03 to 45.81
0.34 Percent Change
Interval -42.86 to 42.9

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=162 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=332 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVa
-15.38 Percent Change
Interval -48.48 to 13.31
-24.86 Percent Change
Interval -55.96 to 10.11

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=162 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=332 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVb
-27.86 Percent Change
Interval -50.0 to -2.41
-35.58 Percent Change
Interval -52.93 to -11.22

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=162 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=332 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVc
-22.02 Percent Change
Interval -35.8 to -3.57
-24.00 Percent Change
Interval -36.55 to -6.88

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=162 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=332 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Ion Mobility - High Density Lipoproteins 2b
-8.99 Percent Change
Interval -19.0 to 1.5
-9.54 Percent Change
Interval -18.19 to 2.06

SECONDARY outcome

Timeframe: 52 Weeks

Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction.

Outcome measures

Outcome measures
Measure
Placebo
n=162 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=332 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Ion Mobility - High Density Lipoproteins 3 and 2a
-3.06 Percent Change
Interval -12.33 to 6.09
-3.58 Percent Change
Interval -12.59 to 6.5

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=162 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=332 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Ion Mobility - Diameter of the Major LDL Particle
1.56 Percent Change
Interval 0.39 to 3.37
2.38 Percent Change
Interval 0.55 to 4.69

SECONDARY outcome

Timeframe: 52 Weeks

Two types of lipoprotein particles were analyzed together as one measurement without distinction.

Outcome measures

Outcome measures
Measure
Placebo
n=150 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=302 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Particles
-30.29 Percent Change
Interval -53.45 to 2.58
-39.09 Percent Change
Interval -59.18 to -7.46

SECONDARY outcome

Timeframe: 52 Weeks

Two types of lipoprotein particles were analyzed together as one measurement without distinction.

Outcome measures

Outcome measures
Measure
Placebo
n=150 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=302 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Particles-Large
-51.23 Percent Change
Interval -70.89 to 2.75
-51.64 Percent Change
Interval -75.46 to -10.2

SECONDARY outcome

Timeframe: 52 Weeks

Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.

Outcome measures

Outcome measures
Measure
Placebo
n=150 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=302 Participants
K-877 0.2 mg tablet BID
Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particles-Medium
-20.70 nmol/L
Interval -70.4 to 15.0
-34.20 nmol/L
Interval -71.1 to -1.2

SECONDARY outcome

Timeframe: 52 Weeks

Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.

Outcome measures

Outcome measures
Measure
Placebo
n=150 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=302 Participants
K-877 0.2 mg tablet BID
Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particles-Small
3.85 nmol/L
Interval -21.9 to 21.8
0.00 nmol/L
Interval -19.0 to 19.4

SECONDARY outcome

Timeframe: 52 Weeks

Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.

Outcome measures

Outcome measures
Measure
Placebo
n=150 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=302 Participants
K-877 0.2 mg tablet BID
Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles (Total)
213.50 nmol/L
Interval -97.0 to 572.0
193.00 nmol/L
Interval -115.0 to 533.0

SECONDARY outcome

Timeframe: 52 Weeks

Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.

Outcome measures

Outcome measures
Measure
Placebo
n=150 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=302 Participants
K-877 0.2 mg tablet BID
Change From Baseline to Week 52 in Lipoprotein Fraction - IDL Particles
-6.50 nmol/L
Interval -133.0 to 75.0
-9.00 nmol/L
Interval -101.0 to 48.0

SECONDARY outcome

Timeframe: 52 Weeks

Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.

Outcome measures

Outcome measures
Measure
Placebo
n=150 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=302 Participants
K-877 0.2 mg tablet BID
Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles-Large
50.50 nmol/L
Interval 0.0 to 215.0
25.50 nmol/L
Interval 0.0 to 280.0

SECONDARY outcome

Timeframe: 52 Weeks

Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.

Outcome measures

Outcome measures
Measure
Placebo
n=150 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=302 Participants
K-877 0.2 mg tablet BID
Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles-Small
138.00 nmol/L
Interval -187.0 to 436.0
81.00 nmol/L
Interval -222.0 to 420.0

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=150 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=302 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles
1.38 Percent Change
Interval -12.57 to 12.45
1.07 Percent Change
Interval -11.5 to 15.46

SECONDARY outcome

Timeframe: 52 Weeks

Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.

Outcome measures

Outcome measures
Measure
Placebo
n=150 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=302 Participants
K-877 0.2 mg tablet BID
Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Large
-0.10 umol/L
Interval -1.2 to 1.2
0.10 umol/L
Interval -1.2 to 1.4

SECONDARY outcome

Timeframe: 52 Weeks

Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.

Outcome measures

Outcome measures
Measure
Placebo
n=150 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=302 Participants
K-877 0.2 mg tablet BID
Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Medium
-1.15 umol/L
Interval -4.1 to 2.0
-0.80 umol/L
Interval -4.8 to 2.1

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=150 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=302 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Small
6.37 Percent Change
Interval -12.5 to 30.46
9.01 Percent Change
Interval -11.19 to 32.2

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=150 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=302 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particle Size
-6.70 Percent Change
Interval -16.08 to 5.51
-6.12 Percent Change
Interval -16.22 to 5.41

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=143 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=286 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particle Size
0.51 Percent Change
Interval 0.0 to 2.54
0.99 Percent Change
Interval 0.0 to 3.08

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=150 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=302 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particle Size
-1.11 Percent Change
Interval -3.49 to 2.33
-1.15 Percent Change
Interval -4.49 to 2.33

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=150 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=302 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - Triglyceride
-48.29 Percent Change
Interval -65.74 to -7.86
-48.01 Percent Change
Interval -70.62 to -22.77

SECONDARY outcome

Timeframe: 52 Weeks

Two types of lipoprotein particles were analyzed together as one measurement without distinction.

Outcome measures

Outcome measures
Measure
Placebo
n=150 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=302 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Triglyceride
-47.69 Percent Change
Interval -65.55 to -7.72
-48.38 Percent Change
Interval -71.4 to -24.22

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=121 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=256 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Cholesterol
-2.63 Percent Change
Interval -17.24 to 12.9
-3.88 Percent Change
Interval -18.74 to 22.4

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=163 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=335 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TG:HDL-C
-65.21 Percent Change
Interval -77.4 to -38.31
-63.46 Percent Change
Interval -80.92 to -32.83

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=163 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=335 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TC:HDL-C
-27.59 Percent Change
Interval -41.2 to -6.65
-27.21 Percent Change
Interval -42.91 to -6.46

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=163 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=335 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C
-32.36 Percent Change
Interval -46.88 to -8.11
-30.63 Percent Change
Interval -48.39 to -7.52

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=157 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=326 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B
24.73 Percent Change
Interval 2.5 to 60.32
28.03 Percent Change
Interval 6.73 to 57.69

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=162 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=334 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo B:Apo A1
-1.76 Percent Change
Interval -13.04 to 14.58
1.05 Percent Change
Interval -16.67 to 18.46

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure
Placebo
n=159 Participants
Placebo matching K-877 0.2 mg tablet BID
K-877
n=329 Participants
K-877 0.2 mg tablet BID
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2
-13.99 Percent Change
Interval -37.76 to 6.76
-20.98 Percent Change
Interval -40.38 to -0.74

Adverse Events

K-877: 12-Week Efficacy

Serious events: 13 serious events
Other events: 3 other events
Deaths: 0 deaths

Placebo: 12-Week Efficacy

Serious events: 5 serious events
Other events: 2 other events
Deaths: 0 deaths

K-877 and Fenofibrate Placebo: 40-Week Extension

Serious events: 17 serious events
Other events: 9 other events
Deaths: 3 deaths

Fenofibrate and K-877 Placebo: 40-Week Extension

Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
K-877: 12-Week Efficacy
n=368 participants at risk
* K-877 0.2 mg Tablets BID * Only AEs with onset in the 12-week efficacy period are included.
Placebo: 12-Week Efficacy
n=183 participants at risk
* Placebo matching K-877 0.2 mg BID * Only AEs with onset in the 12-week efficacy period are included.
K-877 and Fenofibrate Placebo: 40-Week Extension
n=350 participants at risk
* Participants randomized to receive K-877 0.2 mg tablets twice daily in the 12-week Efficacy Period continued to receive K-877 0.2 mg tablets BID, as well as placebo matching fenofibrate 145 mg tablets once daily, in the 40-week Extension Period. * Only AEs with onset in the 40-week extension period are included.
Fenofibrate and K-877 Placebo: 40-Week Extension
n=177 participants at risk
* Participants randomized to receive placebo matching K-877 0.2 mg tablets BID in the 12-week Efficacy Period received fenofibrate 145 mg tablets once daily and placebo matching K-877 0.2 mg tablets BID in the 40-week Extension Period. * Only AEs with onset in the 40-week extension period are included.
Cardiac disorders
Angina unstable
0.54%
2/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.55%
1/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.29%
1/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.56%
1/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Cardiac disorders
Coronary artery disease
0.27%
1/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.55%
1/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.29%
1/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Cardiac disorders
Acute myocardial infarction
0.00%
0/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.29%
1/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Cardiac disorders
Myocardial infarction
0.27%
1/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Cardiac disorders
Myocardial ischaemia
0.27%
1/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Eye disorders
Visual impairment
0.00%
0/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.55%
1/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Gastrointestinal disorders
Dental cyst
0.00%
0/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.29%
1/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Gastrointestinal disorders
Gastrointestinal inflammation
0.00%
0/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.56%
1/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.29%
1/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Gastrointestinal disorders
Oedematous pancreatitis
0.00%
0/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.29%
1/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Gastrointestinal disorders
Pancreatitis acute
0.00%
0/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.29%
1/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
General disorders
Non-cardiac chest pain
0.27%
1/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
General disorders
Sudden death
0.00%
0/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.29%
1/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Hepatobiliary disorders
Cholecystitis acute
0.00%
0/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.29%
1/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Hepatobiliary disorders
Cholelithiasis
0.00%
0/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.29%
1/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Hepatobiliary disorders
Hepatotoxicity
0.27%
1/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Immune system disorders
Allergic granulomatous angiitis
0.27%
1/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Infections and infestations
Appendicitis
0.00%
0/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.29%
1/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Infections and infestations
Pneumonia
0.27%
1/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Infections and infestations
Sepsis
0.27%
1/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Injury, poisoning and procedural complications
Limb traumatic amputation
0.27%
1/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Injury, poisoning and procedural complications
Wrist fracture
0.00%
0/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.29%
1/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
0.00%
0/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.57%
2/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Metabolism and nutrition disorders
Diabetic ketoacidosis
0.27%
1/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Musculoskeletal and connective tissue disorders
Spinal pain
0.27%
1/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
0.00%
0/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.29%
1/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Nervous system disorders
Altered state of consciousness
0.27%
1/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Nervous system disorders
Facial paralysis
0.00%
0/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.29%
1/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Nervous system disorders
Haemorrhage intracranial
0.27%
1/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Nervous system disorders
Syncope
0.00%
0/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.29%
1/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Psychiatric disorders
Depression
0.00%
0/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.56%
1/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Renal and urinary disorders
Calculus urinary
0.00%
0/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.29%
1/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Renal and urinary disorders
Glomerulonephritis chronic
0.00%
0/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.55%
1/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
0.27%
1/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
0.27%
1/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Respiratory, thoracic and mediastinal disorders
Asthma
0.00%
0/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.29%
1/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Skin and subcutaneous tissue disorders
Toxic skin eruption
0.00%
0/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.55%
1/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Vascular disorders
Hypertension
0.00%
0/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.29%
1/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Vascular disorders
Hypotension
0.00%
0/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.29%
1/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Vascular disorders
Peripheral artery aneurysm
0.27%
1/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
Vascular disorders
Peripheral ischaemia
0.00%
0/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.55%
1/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
0.00%
0/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.

Other adverse events

Other adverse events
Measure
K-877: 12-Week Efficacy
n=368 participants at risk
* K-877 0.2 mg Tablets BID * Only AEs with onset in the 12-week efficacy period are included.
Placebo: 12-Week Efficacy
n=183 participants at risk
* Placebo matching K-877 0.2 mg BID * Only AEs with onset in the 12-week efficacy period are included.
K-877 and Fenofibrate Placebo: 40-Week Extension
n=350 participants at risk
* Participants randomized to receive K-877 0.2 mg tablets twice daily in the 12-week Efficacy Period continued to receive K-877 0.2 mg tablets BID, as well as placebo matching fenofibrate 145 mg tablets once daily, in the 40-week Extension Period. * Only AEs with onset in the 40-week extension period are included.
Fenofibrate and K-877 Placebo: 40-Week Extension
n=177 participants at risk
* Participants randomized to receive placebo matching K-877 0.2 mg tablets BID in the 12-week Efficacy Period received fenofibrate 145 mg tablets once daily and placebo matching K-877 0.2 mg tablets BID in the 40-week Extension Period. * Only AEs with onset in the 40-week extension period are included.
Infections and infestations
Nasopharyngitis
0.82%
3/368 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
1.1%
2/183 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
2.6%
9/350 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.
5.1%
9/177 • 52 Weeks
Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.

Additional Information

Director, Clinical Operations

Kowa Research Institute, Inc.

Phone: 919-433-1600

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place