| Primary | DB Period: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24: Intent-to-treat (ITT) Estimand | Adjusted least square (LS) means and standard errors (SE) were obtained from mixed-effect model with repeated measures (MMRM) model. All post-baseline data available up to Week 24 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model. | Analysis was performed on ITT population which included all randomized participants who were analyzed according to the treatment group allocated by randomization. Here, overall number of participants analyzed = participants with available data for this outcome measure. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 | DB Period: Placebo Q4W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. | | OG003 | DB Period: Alirocumab Q4W | Participants received SC injection of alirocumab 150 mg (for BW <50 kg) or 300 mg (for BW >=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. |
| | Units | Counts |
|---|
| Participants | - OG00025
- OG00149
- OG00226
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0009.7± 4.3
- OG001-33.6± 3.4
- OG002-4.4± 3.7
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| The MMRM model included fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation [yes or no] to DFI14223 study, Baseline BW [<50 or >=50 kg]) as per interactive voice response system (IVRS), time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline LDL-C value and Baseline value by time-point interaction. Comparison was performed using an appropriate contrast. | MMRM | | <0.0001 | The threshold for statistical significance was 0.025 level. | LS mean difference | -43.3 | Standard Error of the Mean | 5.5 | 2-Sided | 97.5 | -56.0 | -30.7 | | | Alirocumab Q2W versus Placebo Q2W |
|
| Secondary | DB Period: Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12: ITT Estimand | Adjusted LS means and SE were obtained from MMRM model including all available post-baseline data. All post-baseline data available up to Week 12 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model. | Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 | DB Period: Placebo Q4W | |
|
| Secondary | DB Period: Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24: ITT Estimand | Adjusted LS means and SE were obtained from MMRM model including all available post-baseline data. All post-baseline data available up to Week 24 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model. | Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. . | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 | DB Period: Placebo Q4W | |
|
| Secondary | DB Period: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24: ITT Estimand | Adjusted LS means and SE were obtained from MMRM model including all available post-baseline data. All post-baseline data available up to Week 24 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model. | Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. . | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 | DB Period: Placebo Q4W |
|
| Secondary | DB Period: Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24: ITT Estimand | Adjusted LS means and SE were obtained from MMRM model including all available post-baseline data. All post-baseline data available up to Week 24 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model. | Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. . | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 | DB Period: Placebo Q4W | |
|
| Secondary | DB Period: Percent Change From Baseline in Apolipoprotein B at Week 12: ITT Estimand | Adjusted LS means and SE were obtained from MMRM model including all available post-baseline data. All post-baseline data available up to Week 12 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model. | Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. . | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 | DB Period: Placebo Q4W | |
|
| Secondary | DB Period: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Week 12: ITT Estimand | Adjusted LS means and SE were obtained from MMRM model including all available post-baseline data. All post-baseline data available up to Week 12 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model. | Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. . | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 | DB Period: Placebo Q4W | |
|
| Secondary | DB Period: Percent Change From Baseline in Total Cholesterol at Week 12: ITT Estimand | Adjusted LS means and SE were obtained from MMRM model including all available post-baseline data. All post-baseline data available up to Week 12 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model. | Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. . | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 | DB Period: Placebo Q4W | |
|
| Secondary | DB Period: Percentage of Participants Who Achieved Low Density Lipoprotein Cholesterol Level Lower Than (<) 130 mg/dL (3.37 mmol/L) at Week 24: ITT Estimand | Adjusted percentages at Week 24 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data up to Week 24 were included in the imputation model. | Analysis was performed on ITT population. | Posted | | Number | | percentage of participants | | At Week 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 | DB Period: Placebo Q4W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. |
|
| Secondary | DB Period: Percentage of Participants Who Achieved Low Density Lipoprotein Cholesterol Level <130 mg/dL (3.37 mmol/L) at Week 12: ITT Estimand | Adjusted percentages at Week 12 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data up to Week 12 were included in the imputation model. | Analysis was performed on ITT population. | Posted | | Number | | percentage of participants | | At Week 12 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 | DB Period: Placebo Q4W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. |
|
| Secondary | DB Period: Percentage of Participants Achieving Low Density Lipoprotein Cholesterol <110 mg/dL (2.84 mmol/L) at Week 24: ITT Estimand | Adjusted percentages at Week 24 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data up to Week 24 were included in the imputation model. | Analysis was performed on ITT population. | Posted | | Number | | percentage of participants | | At Week 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 | DB Period: Placebo Q4W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. |
|
| Secondary | DB Period: Percentage of Participants Achieving Low Density Lipoprotein Cholesterol <110 mg/dL (2.84 mmol/L) at Week 12: ITT Estimand | Adjusted percentages at Week 12 were obtained from multiple imputation approach for handling of missing data for Q4W. All available post-baseline data up to Week 12 were included in the imputation model. For Q2W, adjusted percentages at Week 12 were obtained from last observation carried forward approach (LOCF) to handle missing on-treatment LDL-C values as well as missing post-treatment LDL-C values in participants who discontinued treatment due to the coronavirus disease-2019 pandemic. Other post-treatment missing values were considered as failure. | Analysis was performed on ITT population. | Posted | | Number | | percentage of participants | | At Week 12 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 |
|
| Secondary | DB Period: Percent Change From Baseline in Lipoprotein (a) at Week 24: ITT Estimand | Adjusted means and standard errors were obtained from a multiple imputation approach followed by a robust regression model including all available post-baseline data up to Week 24. Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. | Analysis was performed on ITT population. | Posted | | Mean | Standard Error | percent change | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 | DB Period: Placebo Q4W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. |
|
| Secondary | DB Period: Percent Change From Baseline in Lipoprotein (a) at Week 12: ITT Estimand | Adjusted means and standard errors were obtained from a multiple imputation approach followed by a robust regression model including all available post-baseline data up to Week 12. Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. | Analysis was performed on ITT population. | Posted | | Mean | Standard Error | percent change | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 | DB Period: Placebo Q4W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. |
|
| Secondary | DB Period: Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 24: ITT Estimand | Adjusted LS means and SE were obtained from MMRM model. All post-baseline data available up to Week 24 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model. | Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. . | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 | DB Period: Placebo Q4W | |
|
| Secondary | DB Period: Percent Change From Baseline in Fasting Triglycerides (TG) at Week 24: ITT Estimand | Adjusted means and standard errors were obtained from a multiple imputation approach followed by a robust regression model including all available post-baseline data up to Week 24. Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. | Analysis was performed on ITT population. | Posted | | Mean | Standard Error | percent change | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 | DB Period: Placebo Q4W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. |
|
| Secondary | DB Period: Percent Change From Baseline in Apolipoprotein A1 (Apo A1) at Week 24: ITT Estimand | Adjusted LS means and SE were obtained from MMRM model. All post-baseline data available up to Week 24 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model. | Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. . | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 | DB Period: Placebo Q4W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. |
|
| Secondary | DB Period: Percent Change From Baseline in High-Density Lipoprotein Cholesterol at Week 12: ITT Estimand | Adjusted LS means and SE were obtained from MMRM model. All post-baseline data available up to Week 12 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model. | Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. . | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 | DB Period: Placebo Q4W | |
|
| Secondary | DB Period: Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12: ITT Estimand | Adjusted means and standard errors were obtained from a multiple imputation approach followed by a robust regression model including all available post-baseline data up to Week 12. Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. | Analysis was performed on ITT population. | Posted | | Mean | Standard Error | percent change | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 | DB Period: Placebo Q4W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. |
|
| Secondary | DB Period: Percent Change From Baseline in Apolipoprotein A1 at Week 12: ITT Estimand | Adjusted LS means and SE were obtained from MMRM model. All post-baseline data available up to Week 12 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model. | Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. . | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 | DB Period: Placebo Q4W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. |
|
| Secondary | DB Period: Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Weeks 12, and 24: On-treatment Estimand | Adjusted LS means and SE were obtained from MMRM model. All post-baseline on-treatment data available up to Week 12 and Week 24 were used for the MMRM model, i.e., for Q2W data: from 1st investigational medicinal product (IMP) injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for who stopped IMP before switch to Q2W regimen, + 21 days otherwise. MMRM model was run on participants with a Baseline value and at one on-treatment post-baseline value for a timepoint used in the model. | Analysis was performed on modified intent-to-treat (mITT) population which included all randomized participants who took at least one dose or part of a dose of the IMP injection. Here, overall number of participants analyzed = participants with available data for this outcome measure. . | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Weeks 12, and 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. |
|
| Secondary | DB Period: Percent Change From Baseline in Apolipoprotein B at Weeks 12 and 24: On-treatment Estimand | Adjusted LS means and SE were obtained from MMRM model. All post-baseline on-treatment data available up to Week 12 and Week 24 were used for the MMRM model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for who stopped IMP before switch to Q2W regimen, + 21 days otherwise. MMRM model was run on participants with a Baseline value and at one on-treatment post-baseline value for a timepoint used in the model. | Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. . | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Weeks 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. |
|
| Secondary | DB Period: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Weeks 12 and 24: On-treatment Estimand | Adjusted LS means and SE were obtained from MMRM model. All post-baseline on-treatment data available up to Week 12 and Week 24 were used for the MMRM model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for who stopped IMP before switch to Q2W regimen, + 21 days otherwise. MMRM model was run on participants with a Baseline value and at one on-treatment post-baseline value for a timepoint used in the model. | Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. . | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Weeks 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. |
|
| Secondary | DB Period: Percent Change From Baseline in Total Cholesterol at Weeks 12 and 24: On-treatment Estimand | Adjusted LS means and SE were obtained from MMRM model. All post-baseline on-treatment data available up to Week 12 and Week 24 were used for the MMRM model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for who stopped IMP before switch to Q2W regimen, + 21 days otherwise. MMRM model was run on participants with a Baseline value and at one on-treatment post-baseline value for a timepoint used in the model. | Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. . | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Weeks 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. |
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| Secondary | DB Period: Percentage of Participants Who Achieved Low Density Lipoprotein Cholesterol < 130 mg/dL (3.37 mmol/L) at Weeks 12 and 24: On-treatment Estimand | Adjusted percentages at Weeks 12 and 24 were obtained from multiple imputation approach for handling of missing data followed by logistic regression model. All available post-baseline on-treatment data up to Week 12 and Week 24 were included in the imputation model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for those who stopped IMP before switch to Q2W regimen, + 21 days otherwise. | Analysis was performed on mITT population. | Posted | | Number | | percentage of participants | | Weeks 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 | Db Period: Placebo Q4W |
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| Secondary | DB Period: Percentage of Participants Who Achieved Low Density Lipoprotein Cholesterol < 110 mg/dL (2.84 mmol/L) at Weeks 12 and 24: On-treatment Estimand | Adjusted percentages at Weeks 12 and 24 were obtained from multiple imputation approach for handling of missing data followed by logistic regression model. All available post-baseline on-treatment data up to Week 12 and Week 24 were included in the imputation model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for those who stopped IMP before switch to Q2W regimen, + 21 days otherwise. | Analysis was performed on mITT population. | Posted | | Number | | percentage of participants | | Weeks 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 | DB Period: Placebo Q4W |
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| Secondary | DB Period: Percent Change From Baseline in Lipoprotein (a) at Weeks 12 and 24: On-treatment Estimand | Adjusted means and standard errors were obtained from a multiple imputation approach followed by a robust regression model including all available post-baseline on-treatment data up to Week 12 and Week 24, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for those who stopped IMP before switch to Q2W regimen, + 21 days otherwise. Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. | Analysis was performed on mITT population. | Posted | | Mean | Standard Error | percent change | | Baseline, Weeks 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 |
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| Secondary | DB Period: Percent Change From Baseline in Apolipoprotein A1 at Weeks 12 and 24: On-treatment Estimand | Adjusted LS means and SE were obtained from MMRM model. All post-baseline on-treatment data available up to Week 12 and Week 24 were used for the MMRM mode, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for who stopped IMP before switch to Q2W regimen, + 21 days otherwise. MMRM model was run on participants with a Baseline value and at one on-treatment post-baseline value for a timepoint used in the model. | Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. . | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Weeks 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. |
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| Secondary | DB Period: Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24: On-treatment Estimand | Adjusted LS means and SE were obtained from MMRM model. All post-baseline on-treatment data available up to Week 12 and Week 24 were used for the MMRM model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for who stopped IMP before switch to Q2W regimen, + 21 day otherwise. MMRM model was run on participants with a Baseline value and at one on-treatment post-baseline value for a timepoint used in the model. | Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. . | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Weeks 12, and 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. |
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| Secondary | DB Period: Percent Change From Baseline in Fasting Triglycerides at Weeks 12 and 24: On-treatment Estimand | Adjusted means and standard errors were obtained from a multiple imputation approach followed by a robust regression model including all available post-baseline on-treatment data up to Week 12 and Week 24, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for those who stopped IMP before switch to Q2W regimen, + 21 days otherwise. Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. | Analysis was performed on mITT population. | Posted | | Mean | Standard Error | percent change | | Baseline, Weeks 12, and 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 |
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| Secondary | DB Period: Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 12 and 24: ITT Estimand | Adjusted LS means and SE were obtained from MMRM model. All post-baseline data available up to Week 12 and Week 24 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model. | Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. . | Posted | | Least Squares Mean | Standard Error | ratio (Apo B/Apo A-1) | | Baseline, Weeks 12, and 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 | DB Period: Placebo Q4W | |
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| Secondary | DB Period: Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 12 and 24: On-treatment Estimand | Adjusted LS means and SE were obtained from MMRM model. All post-baseline on-treatment data available up to Week 12 and Week 24 were used for the MMRM model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for who stopped IMP before switch to Q2W regimen, + 21 days otherwise. MMRM model was run on participants with a Baseline value and at one on-treatment post-baseline value for a timepoint used in the model. | Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. . | Posted | | Least Squares Mean | Standard Error | ratio (Apo B/Apo A-1) | | Baseline, Weeks 12, and 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. |
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| Secondary | DB Period: Percentage of Participants Who Achieved at Least 30 Percent (%) Reduction in Low Density Lipoprotein Cholesterol Level From Baseline at Weeks 12 and 24: ITT Estimand | Adjusted percentages at Weeks 12 and 24 were obtained from multiple imputation approach for handling of missing data followed by logistic regression model. All available post-baseline on-treatment data up to Week 12 and Week 24 were included in the imputation model. | Analysis was performed on ITT population. | Posted | | Number | | percentage of participants | | At Weeks 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 | DB Period: Placebo Q4W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. |
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| Secondary | DB Period: Percentage of Participants Achieved at Least 30% Reduction in Low Density Lipoprotein Cholesterol Level From Baseline at Weeks 12 and 24: On-treatment Estimand | Adjusted percentages at Weeks 12 and 24 were obtained from multiple imputation approach for handling of missing data followed by logistic regression model. All available post-baseline on-treatment data up to Week 12 and Week 24 were included in the imputation model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for those who stopped IMP before switch to Q2W regimen, + 21 days otherwise. | Analysis was performed on mITT population. | Posted | | Number | | percentage of participants | | At Weeks 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 |
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| Secondary | DB Period: Percentage of Participants Who Achieved at Least 50% Reduction in Low Density Lipoprotein Cholesterol Level From Baseline at Weeks 12 and 24: ITT Estimand | Adjusted percentages at Weeks 12 and 24 were obtained from multiple imputation approach for handling of missing data followed by logistic regression model. All available post-baseline on-treatment data up to Week 12 and Week 24 were included in the imputation model. | Analysis was performed on ITT population. | Posted | | Number | | percentage of participants | | At Weeks 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 | DB Period: Placebo Q4W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. |
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| Secondary | DB Period: Percentage of Participants Who Achieved at Least 50% Reduction in Low Density Lipoprotein Cholesterol Level From Baseline at Weeks 12 and 24: On-treatment Estimand | Adjusted percentages at Weeks 12 and 24 were obtained from multiple imputation approach for handling of missing data followed by logistic regression model. All available post-baseline on-treatment data up to Week 12 and Week 24 were included in the imputation model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for those who stopped IMP before switch to Q2W regimen, + 21 days otherwise. | Analysis was performed on mITT population. | Posted | | Number | | percentage of participants | | At Weeks 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 |
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| Secondary | DB Period: Percent Change in Low Density Lipoprotein Cholesterol From Baseline to Weeks 8, 12 and 24: ITT Estimand | Adjusted LS means and SE were obtained from MMRM model. All post-baseline data available up to Week 8, Week 12 and Week 24 were used and missing data were accounted for by the MMRM model. | Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. . | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline to Weeks 8, 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 | DB Period: Placebo Q4W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q4W for 24 weeks in DB treatment period along with LMT. |
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| Secondary | DB Period: Percent Change in Low Density Lipoprotein Cholesterol From Baseline to Weeks 8, 12 and 24: On-treatment Estimand | Adjusted LS means and SE were obtained from MMRM model. All post-baseline on-treatment data available up to Week 8, Week 12 and Week 24 were used for the MMRM model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for who stopped IMP before switch to Q2W regimen, + 21 days otherwise. | Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. . | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline to Weeks 8, 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. | | OG001 | DB Period: Alirocumab Q2W | Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. | | OG002 | DB Period: Placebo Q4W |
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| Secondary | OL Period: Percent Change in Low Density Lipoprotein Cholesterol From Baseline to Week 104: ITT Estimand | Percent Change in LDL-C from Baseline to Week 104 was reported in this outcome measure. | Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. The IIT estimand was analyzed by considering all the post-baseline (including both on- and post-treatment) LDL-C values for the analysis. . | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Week 104 | | | | ID | Title | Description |
|---|
| OG000 | OL Period: Placebo/Alirocumab Q2W | After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 40 mg to 75 mg when BW increased from <50 kg to >=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 40 mg to 75 mg (for BW <50 kg) or 75 mg to 150 mg (for BW >=50 kg) or down titrated as 75 mg to 40 mg (for BW <50 kg) or 150 mg to 75 mg (for BW >=50 kg). | | OG001 | OL Period: Alirocumab Q2W | After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 40 mg to 75 mg when BW increased from <50 kg to >=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 40 mg to 75 mg (for BW <50 kg) or 75 mg to 150 mg (for BW >=50 kg) or down titrated as 75 mg to 40 mg (for BW <50 kg) or 150 mg to 75 mg (for BW >=50 kg). |
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| Secondary | OL Period: Percent Change in Low Density Lipoprotein Cholesterol From Baseline to Week 104: On-treatment Estimand | Percent Change in LDL-C from Baseline to Week 104 was reported in this outcome measure. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. The on-treatment estimand was analyzed using the same imputation model as ITT Estimand, but considered the 'on-treatment' LDL-C values alone for the analysis. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Week 104 | | | | ID | Title | Description |
|---|
| OG000 | OL Period: Placebo/Alirocumab Q2W | After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 40 mg to 75 mg when BW increased from <50 kg to >=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 40 mg to 75 mg (for BW <50 kg) or 75 mg to 150 mg (for BW >=50 kg) or down titrated as 75 mg to 40 mg (for BW <50 kg) or 150 mg to 75 mg (for BW >=50 kg). | | OG001 | OL Period: Alirocumab Q2W | After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 40 mg to 75 mg when BW increased from <50 kg to >=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 40 mg to 75 mg (for BW <50 kg) or 75 mg to 150 mg (for BW >=50 kg) or down titrated as 75 mg to 40 mg (for BW <50 kg) or 150 mg to 75 mg (for BW >=50 kg). |
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| Secondary | Change From Baseline in Cogstate Battery Test - Overall Composite Score at Weeks 24, 68 and 104 | Cogstate battery test (cognitive testing system) consisted of detection test (DET), identification test (IDN), one card learning test (OCL) and Groton maze learning test (GML) to assess processing speed, attention, visual learning and executive functioning, respectively. For each test, Z-scores were computed based on participant's age at Baseline and Weeks 24, 68 and 104. Composite score: calculated as mean of Z-scores equally weighted, provided that at least 3 of 4 tests were available and if all of these domains were covered as: attention, through either DET or IDN, visual learning, through OCL and executive function, through GML. There is not minimum/maximum since values were reported as z-score but z-score of 0 means result equals to mean with negative numbers indicating values lower than mean and positive values higher. Positive change in z-score = an improvement in cognition, i.e., a better outcome; and negative change in z-score = worsening in cognition, i.e., a worse outcome. | Analysis was performed on safety population which consisted of the randomized population who had actually received at least one dose or partial dose of IMP. Here, number analyzed = participants with available data for each specified category. | Posted | | Mean | Standard Deviation | Z-score | | Baseline, Weeks 24, 68 and 104 | | | | ID | Title | Description |
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| OG000 | Placebo/Alirocumab Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period added to stable LMT. After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 40 mg to 75 mg when BW increased from <50 kg to >=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 40 mg to 75 mg (for BW <50 kg) or 75 mg to 150 mg (for BW >=50 kg) or down titrated as 75 mg to 40 mg (for BW <50 kg) or 150 mg to 75 mg (for BW >=50 kg). |
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| Secondary | Number of Participants With Tanner Staging at Baseline and Weeks 24, 68 and 104 | Tanner stage defines physical measurements of development in children and adolescent based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males) and classified in 3 categories as: Prepubescent (defined as a person just before start of the development of adult sexual characteristics), Pubescent (defined as a person at or approaching the age of puberty), Postpubescent (sexually mature or a person who has completed puberty). | Analysis was performed on safety population. Here, number analyzed = participants with available data for each specified category. | Posted | | Count of Participants | | Participants | | Baseline, Weeks 24, 68 and 104 | | | | ID | Title | Description |
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| OG000 | Placebo/Alirocumab Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period added to stable LMT. After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 40 mg to 75 mg when BW increased from <50 kg to >=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 40 mg to 75 mg (for BW <50 kg) or 75 mg to 150 mg (for BW >=50 kg) or down titrated as 75 mg to 40 mg (for BW <50 kg) or 150 mg to 75 mg (for BW >=50 kg). |
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| Secondary | DB Period: Number of Participants With Treatment-Emergent (TE) Positive Anti-Alirocumab Antibodies (ADA) Response | Anti-drug (alirocumab) antibodies samples were analyzed using a validated non-quantitative, titer-based bridging immunoassay. Number of participants with positive ADA during 24-week treatment period is reported. Treatment-emergent positive ADA response was defined as 1) participants with no ADA positive response at baseline but with any positive response in the post-baseline period or 2) participants with a positive ADA response at baseline and at least a 4- fold increase in titer in the post-baseline period. A persistent positive response was defined as a TE ADA positive response detected in at least 2 consecutive post-baseline samples separated by at least a 12-week period. Persistent positive response was only analyzed for participants with positive TE ADA response. | Analysis was performed on ADA population which included all randomized and treated (who actually received at least one dose or part of a dose of the IMP injection) participants with an available ADA sample at Baseline (Week 0) and at least 1 non-missing ADA sample post first IMP injection and up to Week 24/early termination. Here, 'number analyzed' = participants with available data for each specified category and '0' in number analyzed filed signifies that no participants were evaluable. | Posted | | Count of Participants | | Participants | | Up to 24 weeks | | | | ID | Title | Description |
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| OG000 | DB Period: Placebo Q2W | Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q2W for 24 weeks in DB treatment period along with LMT. |
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