| Primary | Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT Analysis) | Adjusted least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis). | ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment. | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks. | | OG001 | Alirocumab 75 mg/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0001.6± 1.8
- OG001-62.5± 1.3
|
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| | 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 |
|---|
| Alirocumab group was compared to placebo group using an appropriate contrast statement. | Mixed Models Analysis | | <0.0001 | Threshold for significance ≤ 0.05. | LS Mean Difference | -64.1 | | | 2-Sided | 95 | -68.5 | -59.8 | | | | No | Superiority or Other | | |
|
| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis | Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection) (on-treatment analysis). | Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment. | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks. | | OG001 | Alirocumab 75 mg/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. |
| |
| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. | | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks. | | OG001 | Alirocumab 75 mg/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. |
| |
| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis | Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection). | | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks. | | OG001 | Alirocumab 75 mg/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. | Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population). | Posted | | Least Squares Mean | Standard Error | percent change | | From baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks. | | OG001 | Alirocumab 75 mg/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. |
| |
| Secondary | Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis | Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection). | Participants of the mITT population with one baseline and at least one post-baseline Apo-B value on-treatment (Apo B mITT population). | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks. | | OG001 | Alirocumab 75 mg/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. |
| |
| Secondary | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. | Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population). | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks. | | OG001 | Alirocumab 75 mg/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. |
| |
| Secondary | Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection). | Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population). | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks. | | OG001 | Alirocumab 75 mg/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. |
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| Secondary | Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. | Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population). | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks. | | OG001 | Alirocumab 75 mg/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. |
| |
| Secondary | Percent Change From Baseline in Apo B at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. | | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks. | | OG001 | Alirocumab 75 mg/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. |
| |
| Secondary | Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. | Non-HDL-C ITT population. | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks. | | OG001 | Alirocumab 75 mg/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. |
| |
| Secondary | Percent Change From Baseline in Total-C at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. | | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks. | | OG001 | Alirocumab 75 mg/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. |
| |
| Secondary | Percentage of Participants Reaching Calculated LDL-C Goal at Week 24 - ITT Analysis | Calculated LDL-C goal was defined as:
- <100 mg/dL (2.59 mmol/L) for heFH or non-FH participants who had a history of documented congestive heart disease (CHD), or
- <120 mg/dL (3.10 mmol/L) for non-FH participants who had a history of documented diseases (ischemic stroke, peripheral artery disease, chronic kidney disease or diabetes) or other risk factors as defined in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in imputation model. | | Posted | | Number | | percentage of participants | | Up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks. | | OG001 | Alirocumab 75 mg/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. |
| |
| Secondary | Percentage of Participants Reaching Calculated LDL-C Goal at Week 24 - On-Treatment Analysis | Adjusted percentages at Week 24 were from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection). | | Posted | | Number | | percentage of participants | | Up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks. | | OG001 | Alirocumab 75 mg/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. |
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| Secondary | Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis | Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment were included in the imputation model. | | Posted | | Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks. | | OG001 | Alirocumab 75 mg/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. |
| |
| Secondary | Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis | Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment. | | Posted | | Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks. | | OG001 | Alirocumab 75 mg/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. |
| |
| Secondary | Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. | Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population). | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks. | | OG001 | Alirocumab 75 mg/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. |
| |
| Secondary | Percent Change From Baseline in Apo A1 at Week 24 - ITT Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. | Participants of the ITT population with one baseline and at least one post-baseline Apo A1 value on- or off-treatment (Apo A1 ITT population). | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks. | | OG001 | Alirocumab 75 mg/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. |
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| Secondary | Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis | Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment. | | Posted | | Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks. | | OG001 | Alirocumab 75 mg/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. |
| |
| Secondary | Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis | Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment. | | Posted | | Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks. | | OG001 | Alirocumab 75 mg/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. |
| |
| Secondary | Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. | | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks. | | OG001 | Alirocumab 75 mg/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. |
| |
| Secondary | Percent Change From Baseline in Apo A1 at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. | | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks. | | OG001 | Alirocumab 75 mg/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. |
| |
| Other Pre-specified | Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis | Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | | Posted | | Least Squares Mean | Standard Error | Percent change | | From Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks. | | OG001 | Alirocumab 75 mg/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. |
| |
| Other Pre-specified | Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis | Adjusted LS means and standard errors at Week 52 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection). | | Posted | | Least Squares Mean | Standard Error | Percent change | | From Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks. | | OG001 | Alirocumab 75 mg/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. |
| |