| Primary | Percent Change of Fasting Triglyceride(TG) Levels From Baseline to Week 12 | | | Posted | | Median | Inter-Quartile Range | Percent of Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-56.00(-72.08 to -32.40)
- OG001-7.97(-44.78 to 49.87)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Hodges-Lehmann method | | <0.0001 | | | | | | | | | | | | | | Superiority | | |
|
| Secondary | Percent Change From Baseline to Week 12 in Remnant Cholesterol | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in HDL-C | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Apo A1 | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Non-HDL-C | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Total Cholesterol | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in LDL-C | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Free Fatty Acids (FFAs) | | | Posted | | Median | Inter-Quartile Range | Percent Chage | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Apo A2 | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Apo B | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Apo B48 | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Apo B100 | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Apo C2 | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Apo C3 | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Apo E | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Change From Baseline to Week 12 in Fibroblast Growth Factor 21 (FGF21) | | | Posted | | Median | Inter-Quartile Range | pg/mL | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Change From Baseline to Week 12 in hsCRP | | | Posted | | Median | Inter-Quartile Range | mg/L | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Large | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Intermediate | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Small | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility - Intermediate Density Lipoproteins 1 | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility - Intermediate Density Lipoproteins 2 | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins I | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIa | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIb | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIIa | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIIb | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVa | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVb | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVc | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility - High Density Lipoproteins 2b | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility - High Density Lipoproteins 3 and 2a | Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction. | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility - Major LDL Particle Measurement | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Particles | Two types of lipoprotein particles were analyzed together as one measurement without distinction. | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Particles-Large | Two types of lipoprotein particles were analyzed together as one measurement without distinction. | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particles-Medium | | 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. | Posted | | Median | Inter-Quartile Range | nmol/L | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particles-Small | | 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. | Posted | | Median | Inter-Quartile Range | nmol/L | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles (Total) | | 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. | Posted | | Median | Inter-Quartile Range | nmol/L | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Change From Baseline to Week 12 in Lipoprotein Fraction - Intermediate-density Lipoprotein (IDL) Particles | | 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. | Posted | | Median | Inter-Quartile Range | nmol/L | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles-Large | | 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. | Posted | | Median | Inter-Quartile Range | nmol/L | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles-Small | | 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. | Posted | | Median | Inter-Quartile Range | nmol/L | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles (Total) | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Large | | 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. | Posted | | Median | Inter-Quartile Range | μmol/L | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Medium | | 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. | Posted | | Median | Inter-Quartile Range | μmol/L | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Small | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particle Size | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particle Size | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particle Size | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Lipoprotein Fraction - Triglyceride (Total) | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Triglyceride | Two types of lipoprotein particles were analyzed together as one measurement without distinction. | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Cholesterol | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TG:HDL-C | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Total Cholesterol (TC):HDL-C | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo B:Apo A1 | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2 | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo | Placebo matching K-877 0.2 mg tablet BID |
| |
| Secondary | Percent Change From Baseline to Week 52 in Fasting TG | | | Posted | | Median | Inter-Quartile Range | Percent of Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Remnant Cholesterol | | | Posted | | Median | Inter-Quartile Range | Percent of Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in HDL-C | | | Posted | | Median | Inter-Quartile Range | Percent of Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Apo A1 | | | Posted | | Median | Inter-Quartile Range | Percent of Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Non-HDL-C | | | Posted | | Median | Inter-Quartile Range | Percent of Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in TC | | | Posted | | Median | Inter-Quartile Range | Percent of Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in LDL-C | | | Posted | | Median | Inter-Quartile Range | Percent of Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in FFAs | | | Posted | | Median | Inter-Quartile Range | Percent of Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Apo A2 | | | Posted | | Median | Inter-Quartile Range | Percent of Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Apo B | | | Posted | | Median | Inter-Quartile Range | Percent of Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Apo B48 | | | Posted | | Median | Inter-Quartile Range | Percent of Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Apo B100 | | | Posted | | Median | Inter-Quartile Range | Percent of Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Apo C2 | | | Posted | | Median | Inter-Quartile Range | Percent of Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Apo C3 | | | Posted | | Median | Inter-Quartile Range | Percent of Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Apo E | | | Posted | | Median | Inter-Quartile Range | Percent of Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Change From Baseline to Week 52 in FGF21 | | | Posted | | Median | Inter-Quartile Range | pg/mL | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Change From Baseline to Week 52 in hsCRP | | | Posted | | Median | Inter-Quartile Range | mg/L | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Large | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Intermediate | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Small | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility - Intermediate Density Lipoproteins 1 | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility - Intermediate Density Lipoproteins 2 | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins I | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIa | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIb | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIIa | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIIb | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVa | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVb | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVc | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility - High Density Lipoproteins 2b | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility - High Density Lipoproteins 3 and 2a | Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction. | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility - Diameter of the Major LDL Particle | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Particles | Two types of lipoprotein particles were analyzed together as one measurement without distinction. | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Particles-Large | Two types of lipoprotein particles were analyzed together as one measurement without distinction. | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particles-Medium | | 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. | Posted | | Median | Inter-Quartile Range | nmol/L | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particles-Small | | 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. | Posted | | Median | Inter-Quartile Range | nmol/L | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles (Total) | | 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. | Posted | | Median | Inter-Quartile Range | nmol/L | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Change From Baseline to Week 52 in Lipoprotein Fraction - IDL Particles | | 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. | Posted | | Median | Inter-Quartile Range | nmol/L | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles-Large | | 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. | Posted | | Median | Inter-Quartile Range | nmol/L | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles-Small | | 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. | Posted | | Median | Inter-Quartile Range | nmol/L | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Large | | 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. | Posted | | Median | Inter-Quartile Range | umol/L | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Medium | | 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. | Posted | | Median | Inter-Quartile Range | umol/L | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Small | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particle Size | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particle Size | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particle Size | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Lipoprotein Fraction - Triglyceride | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Triglyceride | Two types of lipoprotein particles were analyzed together as one measurement without distinction. | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
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| Secondary | Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Cholesterol | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
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| Secondary | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TG:HDL-C | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
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| Secondary | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TC:HDL-C | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
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| Secondary | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
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| Secondary | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
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| Secondary | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo B:Apo A1 | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
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| Secondary | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2 | | | Posted | | Median | Inter-Quartile Range | Percent Change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | 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. | | OG001 | Placebo/Fenofibrate | 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. |
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