| Primary | Estimated Percentage Change in Fasting Triglyceride(s) (TG) | | The Per-Protocol Set (PPS) was defined as all patients in the Full Analysis Set without any major protocol deviations and who had baseline and Day 28 fasting serum TG measurements. | Posted | | Least Squares Mean | Standard Deviation | Percent Change | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | K-877-IR | K-877 Immediate release (IR) tablet orally twice daily (BID) from day 1 through 28. | | OG001 | K-877-ER Dose A | K-877 Extended release (ER) tablet (Dose A) orally once daily (QD) from day 1 through 28. | | OG002 | K-877-ER Dose B | K-877 Extended release (ER) tablets (Dose B) orally once daily (QD) from day 1 through 28. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-41.57± 3.295
- OG001-36.79± 3.319
- OG002-38.94± 3.553
|
|
| | 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 |
|---|
| | Mixed Model for repeated measures (MMRM) | | 0.3084 | | | | | | | | | | | | | | Non-Inferiority | Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned. | |
|
| Secondary | Percentage Change From Baseline to Day 28 in Total Cholesterol (TC) | | | Posted | | Mean | Standard Deviation | Percent Change | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | K-877-IR | K-877 Immediate release (IR) tablet orally twice daily (BID) from day 1 through 28. | | OG001 | K-877-ER Dose A | K-877 Extended release (ER) tablet (Dose A) orally once daily (QD) from day 1 through 28. | | OG002 | K-877-ER Dose B | K-877 Extended release (ER) tablets (Dose B) orally once daily (QD) from day 1 through 28. |
| |
| Secondary | Percentage Change From Baseline to Day 28 in Low-density Lipoprotein Cholesterol (LDL-C) | | | Posted | | Mean | Standard Deviation | Percent Change | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | K-877-IR | K-877 Immediate release (IR) tablet orally twice daily (BID) from day 1 through 28. | | OG001 | K-877-ER Dose A | K-877 Extended release (ER) tablet (Dose A) orally once daily (QD) from day 1 through 28. | | OG002 | K-877-ER Dose B | K-877 Extended release (ER) tablets (Dose B) orally once daily (QD) from day 1 through 28. |
| |
| Secondary | Percentage Change From Baseline to Day 28 in High-density Lipoprotein Cholesterol (HDL-C) | | | Posted | | Mean | Standard Deviation | Percent Change | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | K-877-IR | K-877 Immediate release (IR) tablet orally twice daily (BID) from day 1 through 28. | | OG001 | K-877-ER Dose A | K-877 Extended release (ER) tablet (Dose A) orally once daily (QD) from day 1 through 28. | | OG002 | K-877-ER Dose B | K-877 Extended release (ER) tablets (Dose B) orally once daily (QD) from day 1 through 28. |
| |
| Secondary | Percentage Change From Baseline to Day 28 in Remnant Cholesterol | | | Posted | | Mean | Standard Deviation | Percentage Change | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | K-877-IR | K-877 Immediate release (IR) tablet orally twice daily (BID) from day 1 through 28. | | OG001 | K-877-ER Dose A | K-877 Extended release (ER) tablet (Dose A) orally once daily (QD) from day 1 through 28. | | OG002 | K-877-ER Dose B | K-877 Extended release (ER) tablets (Dose B) orally once daily (QD) from day 1 through 28. |
| |
| Secondary | Percentage Change From Baseline to Day 28 in Non-HDL-C | | | Posted | | Mean | Standard Deviation | Percent Change | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | K-877-IR | K-877 Immediate release (IR) tablet orally twice daily (BID) from day 1 through 28. | | OG001 | K-877-ER Dose A | K-877 Extended release (ER) tablet (Dose A) orally once daily (QD) from day 1 through 28. | | OG002 | K-877-ER Dose B | K-877 Extended release (ER) tablets (Dose B) orally once daily (QD) from day 1 through 28. |
| |
| Secondary | Percentage Change From Baseline to Day 28 in Free Fatty Acid (FFAs) | | | Posted | | Mean | Standard Deviation | Percent Change | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | K-877-IR | K-877 Immediate release (IR) tablet orally twice daily (BID) from day 1 through 28. | | OG001 | K-877-ER Dose A | K-877 Extended release (ER) tablet (Dose A) orally once daily (QD) from day 1 through 28. | | OG002 | K-877-ER Dose B | K-877 Extended release (ER) tablets (Dose B) orally once daily (QD) from day 1 through 28. |
| |
| Secondary | K-877 PK Parameters Cmax | Observed maximum measured plasma concentration (Cmax) | The PK Analysis Set included all patients from the Safety Analysis Set who had at least 1 PK sample. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Day 28 | | | | ID | Title | Description |
|---|
| OG000 | K-877-IR | K-877 Immediate release (IR) tablet orally twice daily (BID) from day 1 through 28. | | OG001 | K-877-ER Dose A | K-877 Extended release (ER) tablet (Dose A) orally once daily (QD) from day 1 through 28. | | OG002 | K-877-ER Dose B | K-877 Extended release (ER) tablets (Dose B) orally once daily (QD) from day 1 through 28. |
| |
| Secondary | K-877 PK Parameters AUC (Tau) | | The PK Analysis Set included all patients from the Safety Analysis Set who had at least 1 PK sample. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h-ng/mL | | Day 28 | | | | ID | Title | Description |
|---|
| OG000 | K-877-IR | K-877 Immediate release (IR) tablet orally twice daily (BID) from day 1 through 28. | | OG001 | K-877-ER Dose A | K-877 Extended release (ER) tablet (Dose A) orally once daily (QD) from day 1 through 28. | | OG002 | K-877-ER Dose B | K-877 Extended release (ER) tablets (Dose B) orally once daily (QD) from day 1 through 28. |
| |