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)

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=5 Participants	176 Participants n=7 Participants	527 Participants n=5 Participants
Age, Customized Age (Years) · ≥65	17 Participants n=5 Participants	7 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Female	97 Participants n=5 Participants	39 Participants n=7 Participants	136 Participants n=5 Participants
Sex: Female, Male Male	271 Participants n=5 Participants	144 Participants n=7 Participants	415 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants n=5 Participants	8 Participants n=7 Participants	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	341 Participants n=5 Participants	175 Participants n=7 Participants	516 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	358 Participants n=5 Participants	180 Participants n=7 Participants	538 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Triglycerides	810.98 mg/dL STANDARD_DEVIATION 369.284 • n=5 Participants	819.25 mg/dL STANDARD_DEVIATION 414.722 • n=7 Participants	813.73 mg/dL STANDARD_DEVIATION 384.611 • n=5 Participants

PRIMARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

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

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

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

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

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

Outcome measures

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

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

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

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

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

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

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

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

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

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

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure	K-877 n=368 Participants K-877 0.2 mg tablet BID	Placebo n=183 Participants Placebo matching 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	-25.84 Percent Change Interval -42.29 to -4.77	-3.86 Percent Change Interval -22.83 to 19.87

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure	K-877 n=368 Participants K-877 0.2 mg tablet BID	Placebo n=183 Participants Placebo matching 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	-30.79 Percent Change Interval -47.69 to -5.64	-4.49 Percent Change Interval -25.49 to 23.46

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

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

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

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

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

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

Outcome measures

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

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

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

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

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

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

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

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	K-877 n=302 Participants K-877 0.2 mg tablet BID	Placebo n=150 Participants Placebo matching 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 1.4	-0.10 umol/L Interval -1.2 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	K-877 n=302 Participants K-877 0.2 mg tablet BID	Placebo n=150 Participants Placebo matching K-877 0.2 mg tablet BID
Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Medium	-0.80 umol/L Interval -4.8 to 2.1	-1.15 umol/L Interval -4.1 to 2.0

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

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

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

Outcome measures
Measure	K-877 n=335 Participants K-877 0.2 mg tablet BID	Placebo n=163 Participants Placebo matching 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	-30.63 Percent Change Interval -48.39 to -7.52	-32.36 Percent Change Interval -46.88 to -8.11

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

SECONDARY outcome

Timeframe: 52 Weeks

Outcome measures

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

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

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

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place