| 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 up to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis). | ITT population that included all randomized participants with one baseline and at least one post-baseline calculated LDL-C 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 24 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0006.3± 2.9
- OG001-57.1± 3.0
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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 |
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| Alirocumab group was compared to placebo group using an appropriate contrast statement. | Mixed Models Analysis | | <0.0001 | Threshold for significance at 0.05 level. | Least Square (LS) Mean Difference | -63.4 | | | 2-Sided | 95 | -71.6 | -55.2 | | | Alirocumab 75 mg Q2W/ Up to 150 mg Q2W vs. Placebo Q2W | | Superiority | | |
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| 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 up to Week 24 (i.e. up to 21 days after last injection) (on-treatment analysis). | Modified ITT (mITT) population that included 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 24 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up 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 24 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis | Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data up 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 24 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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| Secondary | Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis | Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up 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 24 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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| 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 up 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 24 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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| 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 were obtained from MMRM model including all available post-baseline data up 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 24 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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| Secondary | Percent Change From Baseline in Non-HDL-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 up 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 Deviation | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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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 were obtained from MMRM model including all available post-baseline data up 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 Deviation | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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| Secondary | Percent Change From Baseline in Apo B at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up 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 24 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
| |
| Secondary | Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment. | Non-HDL-C ITT population. | Posted | | Least Squares Mean | Standard Deviation | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
| |
| Secondary | Percent Change From Baseline in Total-C at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up 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 24 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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| Secondary | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis | Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data up to Week 24 regardless of status on- or off-treatment were included in the imputation model. | | Posted | | Number | | percentage of participants | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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| Secondary | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-treatment Analysis | Adjusted percentages at Week 24 were obtained from multiple imputation approach model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection). | | Posted | | Number | | percentage of participants | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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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 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data up 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 24 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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| Secondary | Percent Change From Baseline in High Density Lipoprotein (HDL-C) at Week 24 - ITT Analysis | Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up 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 24 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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| Secondary | Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis | Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model including all available post-baseline data up 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 24 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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| Secondary | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis | Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up 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 A-1 value on- or off-treatment (Apo A-1 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 24 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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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 were obtained from multiple imputation approach followed by robust regression model including all available post-baseline data up 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 24 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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| Secondary | Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up 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 24 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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| Secondary | Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis | Adjusted means and standard errors at Week 12 were obtained from multiple imputation approach followed by a robust regression model including all available post-baseline data up 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 24 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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| Secondary | Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up 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 24 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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