| Primary | Percent Change From Baseline in Calculated LDL-C in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis | Adjusted LS means and standard errors at Week 24 and at averaged Week 21 to 24 from MMRM including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. ITT population (subjects without concomitant statin therapy): all randomized subjects who did not receive concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment. Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | ITT population (participants without concomitant statin therapy): all randomized participants who did not receive concomitant statin therapy, 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 Without Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. | | OG002 | Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin | Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. |
| | | Title | Denominators | Categories |
|---|
| At Week 24 | | | Title | Measurements |
|---|
| - OG000-0.3± 2.7
- OG001-50.2± 3.7
- OG002-52.7± 1.9
|
| | At averaged Week 21 to 24 |
| | 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 Models Analysis | | <0.0001 | Threshold for significance ≤ 0.025. | LS Mean Difference | -52.4 | | | 2-Sided | 97.5 | -59.8 | -45.0 | | | | | Superiority or Other | Alirocumab 300 mg group was compared to placebo group using an appropriate contrast statement. | | |
|
| Primary | Percent Change From Baseline in Calculated LDL-C in Participants Receiving Concomitant Statin Therapy - Intent-to-Treat (ITT Analysis) | Adjusted least squares (LS) means and standard errors at Week 24 and at averaged Week 21 to 24 were obtained from a mixed effect model with repeated measures (MMRM) model 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 this model (ITT analysis). ITT population (subjects with concomitant statin therapy): all randomized subjects who received concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment. Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | ITT population (participants with concomitant statin therapy): all randomized participants who received concomitant statin therapy, 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 With Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin | |
|
| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 24 in Participants Not Receiving Concomitant Statin Therapy - 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 (subjects with or without concomitant statin therapy): all randomized and treated subjects who did not receive concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on-treatment. Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | Modified ITT (mITT) population (participants without concomitant statin therapy): all randomized and treated participants who did not receive concomitant statin therapy, 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 Without Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin | |
|
| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 24 in Participants Receiving Concomitant Statin Therapy - 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 (subjects with or without concomitant statin therapy): all randomized and treated subjects who did not receive concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on-treatment. Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W With Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. |
|
| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 12 in Participants Not Receiving Concomitant Statin Therapy - 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. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | ITT population (participants without concomitant statin therapy) | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W Without Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. | |
|
| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 12 in Participants Receiving Concomitant Statin Therapy - 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. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | ITT population (participants with concomitant statin therapy) | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W With Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. | | OG002 |
|
| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 12 in Participants Not Receiving Concomitant Statin Therapy - On-treatment 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. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | mITT population (participants without concomitant statin therapy) | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W Without Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. | |
|
| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 12 in Participants Receiving Concomitant Statin Therapy - On-treatment 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. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | mITT population (participants with concomitant statin therapy) | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W With Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. | |
|
| Secondary | Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 in Participants Not Receiving Concomitant Statin Therapy - 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. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | Apo B ITT population (participants without concomitant statin therapy) | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W Without Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8 |
|
| Secondary | Percent Change From Baseline in Apo B at Week 24 in Participants Receiving Concomitant Statin Therapy - 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. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | Apo B ITT population (participants with concomitant statin therapy) | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W With Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. |
|
| Secondary | Percent Change From Baseline in Apo B at Week 24 in Participants Not Receiving Concomitant Statin Therapy - On-Treatment 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. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | Apo B mITT population (participants without concomitant statin therapy) | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W Without Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. |
|
| Secondary | Percent Change From Baseline in Apo B at Week 24 in Participants Receiving Concomitant Statin Therapy - On-Treatment 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. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | Apo B mITT population (participants with concomitant statin therapy) | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W With Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. |
|
| Secondary | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 in Participants Not Receiving Concomitant Statin Therapy - 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. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | Non-HDL-C ITT population (participants without concomitant statin therapy) | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W Without Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. |
|
| Secondary | Percent Change From Baseline in Non-HDL-C at Week 24 in Participants Receiving Concomitant Statin Therapy - 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. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | Non-HDL-C ITT population (participants with concomitant statin therapy) | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W With Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. |
|
| Secondary | Percent Change From Baseline in Non-HDL-C at Week 24 in Participants Not Receiving Concomitant Statin Therapy - 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). Subjects of the mITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | Non-HDL-C mITT population (participants without concomitant statin therapy) | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W Without Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. |
|
| Secondary | Percent Change From Baseline in Non-HDL-C at Week 24 in Participants Receiving Concomitant Statin Therapy - 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). Subjects of the mITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | Non-HDL-C mITT population (participants with concomitant statin therapy) | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W With Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. |
|
| Secondary | Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 in Participants Not Receiving Concomitant Statin Therapy - 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. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | Total-C ITT population (participants without concomitant statin therapy) | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W Without Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. |
|
| Secondary | Percent Change From Baseline in Total-C at Week 24 in Participants Receiving Concomitant Statin Therapy - 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. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | Total-C ITT population (participants with concomitant statin therapy) | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W With Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. |
|
| Secondary | Percent Change From Baseline in Apo B at Week 12 in Participants Not Receiving Concomitant Statin Therapy - 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. Apo B ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | Apo B ITT population (participants without concomitant statin therapy) | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W Without Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. | |
|
| Secondary | Percent Change From Baseline in Apo B at Week 12 in Participants Receiving Concomitant Statin Therapy - 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. Apo B ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | Apo B ITT population (participants with concomitant statin therapy). | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W With Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. | |
|
| Secondary | Percent Change From Baseline in Non-HDL-C at Week 12 in Participants Not Receiving Concomitant Statin Therapy - 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 (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | Non-HDL-C ITT population (participants without concomitant statin therapy). | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W Without Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. | |
|
| Secondary | Percent Change From Baseline in Non-HDL-C at Week 12 in Participants Receiving Concomitant Statin Therapy - 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 (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | Non-HDL-C ITT population (participants with concomitant statin therapy). | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W With Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. | |
|
| Secondary | Percent Change From Baseline in Total-C at Week 12 in Participants Not Receiving Concomitant Statin Therapy - 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. Total-C ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | Total-C ITT population (participants without concomitant statin therapy) | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W Without Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. | |
|
| Secondary | Percent Change From Baseline in Total-C at Week 12 in Participants Receiving Concomitant Statin Therapy - 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. Total-C ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | Total-C ITT population (participants with concomitant statin therapy) | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W With Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. | |
|
| Secondary | Percentage of Very High CV Risk Participants Reaching Calculated LDL-C<70 mg/dL or Moderate or High CV Risk Participants Reaching Calculated LDL-C<100 mg/dL (Without Concomitant Statin Therapy) at Week 24 - ITT Analysis | Very high CV risk: history of documented coronary heart disease (CHD) or CHD risk equivalent. High CV risk: calculated 10-year fatal CVD risk score ≥5%, moderate chronic kidney disease, type 1/type 2 diabetes mellitus (DM) without target organ damage, or heFH not meeting definition of very high risk. Moderate CV risk: calculated 10-year fatal CVD risk score ≥1 &<5%. CHD risk equivalent: peripheral arterial disease, ischemic stroke, transient ischemic attack, abdominal aortic aneurysm, carotid artery(CA)occlusion>50%, carotid endarterectomy/CA stent procedure, renal artery stenosis/stent procedure, type 1/type 2 DM with target organ damage. Adjusted percentages at Week 24 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 included in imputation model. ITT population (subjects with or without concomitant statin therapy). | ITT population (participants without concomitant statin therapy) | Posted | | Number | | percentage of participants | | Up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W Without Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin |
|
| Secondary | Percentage of Very High Cardiovascular (CV) Risk Participants Reaching Calculated LDL-C <70 mg/dL or Moderate or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (With Concomitant Statin Therapy) at Week 24 - ITT Analysis | Very high CV risk: history of documented coronary heart disease (CHD) or CHD risk equivalent. High CV risk: calculated 10-year fatal CVD risk score ≥5%, moderate chronic kidney disease, type 1/type 2 diabetes mellitus (DM) without target organ damage, or heFH not meeting definition of very high risk. Moderate CV risk: calculated 10-year fatal CVD risk score ≥1 &<5%. CHD risk equivalent: peripheral arterial disease, ischemic stroke, transient ischemic attack, abdominal aortic aneurysm, carotid artery(CA)occlusion>50%, carotid endarterectomy/CA stent procedure, renal artery stenosis/stent procedure, type 1/type 2 DM with target organ damage. Adjusted percentages at Week 24 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 included in imputation model. ITT population (subjects with or without concomitant statin therapy). | ITT population (participants with concomitant statin therapy) | Posted | | Number | | percentage of participants | | Up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W With Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin |
|
| Secondary | Percentage of Very High CV Risk Participants Reaching Calculated LDL-C<70 mg/dL (1.81 mmol/L) or Moderate or High CV Risk Participants Reaching Calculated LDL-C<100 mg/dL(2.59 mmol/L) (Without Concomitant Statin Therapy) 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). mITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | mITT population (participants without concomitant statin therapy) | Posted | | Number | | percentage of participants | | Up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W Without Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. |
|
| Secondary | Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL(1.81 mmol/L) or Moderate or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL(2.59 mmol/L) (With Concomitant Statin Therapy) 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). mITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | mITT population (participants with concomitant statin therapy) | Posted | | Number | | percentage of participants | | Up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W With Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. |
|
| Secondary | Percentage of Participants (Without Concomitant Statin Therapy) 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 from Week 4 to Week 24 regardless of status on- or off-treatment were included in the imputation model. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | ITT population (participants without concomitant statin therapy) | Posted | | Number | | percentage of participants | | Up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W Without Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. |
|
| Secondary | Percentage of Participants (With Concomitant Statin Therapy) 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 from Week 4 to Week 24 regardless of status on- or off-treatment were included in the imputation model. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | ITT population (participants with concomitant statin therapy) | Posted | | Number | | percentage of participants | | Up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W With Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. |
|
| Secondary | Percentage of Participants (Without Concomitant Statin Therapy) Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis | Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline data from Week 4 to Week 24 (i.e. up to 21 days after last injection). mITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | mITT population (participants without concomitant statin therapy) | Posted | | Number | | percentage of participants | | Up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W Without Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. | |
|
| Secondary | Percentage of Participants (With Concomitant Statin Therapy) Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis | Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline data from Week 4 to Week 24 (i.e. up to 21 days after last injection). mITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | mITT population (participants with concomitant statin therapy) | Posted | | Number | | percentage of participants | | Up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W With Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. | | OG002 |
|
| Secondary | Percent Change From Baseline in Lipoprotein (a) in Participants Not Receiving Concomitant Statin Therapy 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. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | ITT population (participants without concomitant statin therapy) | Posted | | Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W Without Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. |
|
| Secondary | Percent Change From Baseline in Lipoprotein (a) in Participants Receiving Concomitant Statin Therapy 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. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | ITT population (participants with concomitant statin therapy) | Posted | | Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W With Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. |
|
| Secondary | Percent Change From Baseline in Lipoprotein (a) in Participants Not Receiving Concomitant Statin Therapy 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. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | ITT population (participants without concomitant statin therapy) | Posted | | Mean | Standard Error | percent change | | From Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W Without Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. |
|
| Secondary | Percent Change From Baseline in Lipoprotein (a) in Participants Receiving Concomitant Statin Therapy 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. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | ITT population (participants with concomitant statin therapy) | Posted | | Mean | Standard Error | percent change | | From Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W With Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. | |
|
| Secondary | Percent Change From Baseline in HDL-C in Participants Not Receiving Concomitant Statin Therapy 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. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | HDL-C ITT population (participants without concomitant statin therapy) | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W Without Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. |
|
| Secondary | Percent Change From Baseline in HDL-C in Participants Receiving Concomitant Statin Therapy 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. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm | HDL-C ITT population (participants with concomitant statin therapy) | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W With Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. |
|
| Secondary | Percent Change From Baseline in HDL-C in Participants Not Receiving Concomitant Statin Therapy 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. HDL-C ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | HDL-C ITT population (participants without concomitant statin therapy) | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W Without Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. | |
|
| Secondary | Percent Change From Baseline in HDL-C in Participants Receiving Concomitant Statin Therapy 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. HDL-C ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | HDL-C ITT population (participants with concomitant statin therapy) | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W With Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. | |
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| Secondary | Percent Change From Baseline in Fasting Triglycerides in Participants Not Receiving Concomitant Statin Therapy 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. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | ITT population (participants without concomitant statin therapy) | Posted | | Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W Without Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. |
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| Secondary | Percent Change From Baseline in Fasting Triglycerides in Participants Receiving Concomitant Statin Therapy 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. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | ITT population (participants with concomitant statin therapy) | Posted | | Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W With Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. |
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| Secondary | Percent Change From Baseline in Fasting Triglycerides in Participants Not Receiving Concomitant Statin Therapy 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. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | ITT population (participants without concomitant statin therapy) | Posted | | Mean | Standard Error | percent change | | From Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W Without Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. |
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| Secondary | Percent Change From Baseline in Fasting Triglycerides in Participants Receiving Concomitant Statin Therapy 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. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | ITT population (participants with concomitant statin therapy) | Posted | | Mean | Standard Error | percent change | | From Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W With Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. |
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| Secondary | Percent Change From Baseline in Apo A1 in Participants Not Receiving Concomitant Statin Therapy 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. Subjects of the ITT population (subjects with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo A1 value on- or off-treatment (Apo A1 ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | Apo A1 ITT population (participants without concomitant statin therapy) | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W Without Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. |
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| Secondary | Percent Change From Baseline in Apo A1 in Participants Receiving Concomitant Statin Therapy 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. Subjects of the ITT population (subjects with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo A1 value on- or off-treatment (Apo A1 ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | Apo A1 ITT population (participants with concomitant statin therapy) | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W With Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. |
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| Secondary | Percent Change From Baseline in Apo A1 in Participants Not Receiving Concomitant Statin Therapy 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. Apo A1 ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | Apo A1 ITT population (participants without concomitant statin therapy) | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W Without Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. | |
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| Secondary | Percent Change From Baseline in Apo A1 in Participants Receiving Concomitant Statin Therapy 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. Apo A1 ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm. | Apo A1 ITT population (participants with concomitant statin therapy) | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W With Concomitant Statin | Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks. | | OG001 | Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin | One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8. | |
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