| Primary | Percent Change in Fasting TG From Baseline to Week 12 | | | 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 |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-58.89(-71.69 to -38.42)
- OG001-22.94(-43.98 to 9.67)
|
|
| | 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 FFAs | | | 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 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 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 (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 (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 (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 (Diameter of the Major LDL Particle (Ã…)) | | | 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 | 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. | 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-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 | Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles) | | | 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 (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) | | | 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 | Change From Baseline to Week 12 in Lipoprotein Fraction (HDL 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 | 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 (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) | | | 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 (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 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 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 | Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B | | 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 | Ratio | | 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 change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Remnant Cholesterol | | | Posted | | Median | Inter-Quartile Range | Percent change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| Secondary | Percent Change From Baseline to Week 52 in HDL-C | | | Posted | | Median | Inter-Quartile Range | Percent change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Apo A1 | | | Posted | | Median | Inter-Quartile Range | Percent change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Non-HDL-C | | | Posted | | Median | Inter-Quartile Range | Percent change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| Secondary | Percent Change From Baseline to Week 52 in TC | | | Posted | | Median | Inter-Quartile Range | Percent change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| Secondary | Percent Change From Baseline to Week 52 in LDL-C | | | Posted | | Median | Inter-Quartile Range | Percent change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| Secondary | Percent Change From Baseline to Week 52 in FFAs | | | Posted | | Median | Inter-Quartile Range | Percent change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Apo A2 | | | Posted | | Median | Inter-Quartile Range | Percent change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Apo B | | | Posted | | Median | Inter-Quartile Range | Percent change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Apo B48 | | | Posted | | Median | Inter-Quartile Range | Percent change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Apo B100 | | | Posted | | Median | Inter-Quartile Range | Percent change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Apo C2 | | | Posted | | Median | Inter-Quartile Range | Percent change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Apo C3 | | | Posted | | Median | Inter-Quartile Range | Percent change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Apo E | | | Posted | | Median | Inter-Quartile Range | Percent change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| Secondary | Change From Baseline to Week 52 in FGF21 | | | Posted | | Median | Inter-Quartile Range | pg/mL | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| Secondary | Change From Baseline to Week 52 in hsCRP | | | Posted | | Median | Inter-Quartile Range | mg/L | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility (Diameter of the Major LDL Particle (Ã…)) | | | Posted | | Median | Inter-Quartile Range | Percent change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| Secondary | 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. | 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| Secondary | Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles) | | | Posted | | Median | Inter-Quartile Range | Percent change | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| Secondary | Change From Baseline to Week 52 in Lipoprotein Fraction (HDL 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 | umol/L | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| Secondary | Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B | | 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 | Ratio | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | K-877 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |
| 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 | | | OG001 | Placebo/Fenofibrate | Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. |
| |