| Primary | Percent Change From Baseline in LDL-C at Week 12 | | Full analysis set. Least squares (LS) means are from a repeated measures linear effects model; missing values were not imputed. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. |
| | Units | Counts |
|---|
| Participants | - OG00054
- OG00155
- OG002110
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-2.02± 2.49
- OG0015.53± 3.25
- OG002-61.25± 1.77
- OG003
|
|
| | 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 |
|---|
| Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist. | Repeated measures linear effects model | The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit. | <0.001 | Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05. | LS Mean Treatment Difference | -59.23 | Standard Error of the Mean | 2.98 | 2-Sided | 95 | -65.11 | -53.35 | | | |
|
| Primary | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. |
| |
| Secondary | Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | | | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline and Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. |
| |
| Secondary | Change From Baseline in LDL-C at Week 12 | | | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. |
| |
| Secondary | Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L) | | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. |
| |
| Secondary | Percentage of Participants With LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12 | | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Non-HDL-C at Week 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein B at Week 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Lipoprotein (a) at Week 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Triglycerides at Week 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in HDL-C at Week 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in VLDL-C at Week 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. |
| |