| Primary | Percent Change From Baseline at Week 12 in Fasting Low Density Lipoprotein Cholesterol (LDL-C) Level for Bococizumab 150 mg Dose Group and Matched Placebo | | Full analysis set included all participants who were randomized. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Matched to Bococizumab 150 mg | Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks. | | OG001 | Bococizumab 150 mg | Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0006.2± 3.57
- OG001-57.2± 2.57
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| LS-mean difference, associated 95% confidence intervals, and p-value are from MMRM model with fixed effects for treatment groups, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction as covariates. | Mixed Models Repeated Measures (MMRM) | | <0.001 | | LS Mean Difference | -63.4 | Standard Error of the Mean | 4.40 | 2-Sided | 95 | -72.0 | -54.7 | | | | | Superiority or Other | | |
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| Primary | Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 0 (Day 1) | A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?" | Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol. | Posted | | Number | | percentage of injections | | Week 0 (Day 1) | injections | injections | | ID | Title | Description |
|---|
| OG000 | Bococizumab 150 mg | Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks. |
| |
| Primary | Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 2 | A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?" | Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol. | Posted | | Number | | percentage of injections | | Week 2 | injections | injections | | ID | Title | Description |
|---|
| OG000 | Bococizumab 150 mg | Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks. |
| |
| Primary | Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 4 | A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?" | Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol. | Posted | | Number | | percentage of injections | | Week 4 | injections | injections | | ID | Title | Description |
|---|
| OG000 | Bococizumab 150 mg | Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks. |
| |
| Primary | Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 6 | A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?" | Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol. | Posted | | Number | | percentage of injections | | Week 6 | injections | injections | | ID | Title | Description |
|---|
| OG000 | Bococizumab 150 mg | Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks. |
| |
| Primary | Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 8 | A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?" | Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol. | Posted | | Number | | percentage of injections | | Week 8 | injections | injections | | ID | Title | Description |
|---|
| OG000 | Bococizumab 150 mg | Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks. |
| |
| Primary | Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 10 | A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?" | Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol. | Posted | | Number | | percentage of injections | | Week 10 | injections | injections | | ID | Title | Description |
|---|
| OG000 | Bococizumab 150 mg | Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks. |
| |
| Secondary | Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 75 mg Dose Group and Combined Bococizumab 150 mg and 75 mg Dose Group at Week 0 (Day 1), 2, 4, 6, 8 and 10 | A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?" | Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol. | Posted | | Number | | percentage of injections | | Week 0 (Day 1), 2, 4, 6, 8, 10 | injections | injections | | ID | Title | Description |
|---|
| OG000 | Bococizumab 75 mg | Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks. | | OG001 | Bococizumab 150 mg + Bococizumab 75 mg | Participants received single dose of Bococizumab 150 mg SC injection in treatment arm Bococizumab 150 mg and Bococizumab 75 mg SC injection in treatment arm Bococizumab 75 mg, once every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks. |
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| Secondary | Percentage of Injections That Met the Definition for Successful Assessment Using the Observer Assessment Tool (OAT) for Bococizumab 150 mg Dose, Bococizumab 75 mg Dose Group and Combined Bococizumab 150 mg and 75 mg Dose Group at Week 0 (Day 1), 4 and 8 | As per the OAT, a 'successful' injection was based on observer's response for the question - "Was the administration successful?''. Observer's response being 'Yes' corresponded to a successful injection. | Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms as pre-specified in protocol. | Posted | | Number | | percentage of injections | | Week 0 (Day 1), 4, 8 | injections | injections | | ID | Title | Description |
|---|
| OG000 | Bococizumab 150 mg | Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks. | | OG001 | Bococizumab 75 mg | Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks. | | OG002 | Bococizumab 150 + Bococizumab 75 mg | Participants received single dose of Bococizumab 150 mg SC injection in treatment arm Bococizumab 150 mg and Bococizumab 75 mg SC injection in treatment arm Bococizumab 75 mg, once every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks. |
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| Secondary | Percent Change From Baseline at Week 12 in Fasting Low Density Lipoprotein Cholesterol (LDL-C) Level for Bococizumab 75 mg Dose Group and Matched Placebo | | Full analysis set included all participants who were randomized. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Matched to Bococizumab 75 mg | Participants received single dose of placebo matched to bococizumab 75 mg subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks. | | OG001 | Bococizumab 75 mg | Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks. |
| |
| Secondary | Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12 | | Full analysis set included all participants who were randomized. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Matched to Bococizumab 150 mg | Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks. | | OG001 | Bococizumab 150 mg | Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks. | | OG002 | Placebo Matched to Bococizumab 75 mg | Participants received single dose of placebo matched to bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks. | | OG003 | Bococizumab 75 mg |
|
| Secondary | Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 | | Full analysis set included all participants who were randomized. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Matched to Bococizumab 150 mg | Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks. | | OG001 | Bococizumab 150 mg | Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks. | | OG002 | Placebo Matched to Bococizumab 75 mg | Participants received single dose of placebo matched to bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks. | | OG003 | Bococizumab 75 mg |
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| Secondary | Percent Change From Baseline in Fasting Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 | | Full analysis set included all participants who were randomized. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Matched to Bococizumab 150 mg | Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks. | | OG001 | Bococizumab 150 mg | Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks. | | OG002 | Placebo Matched to Bococizumab 75 mg | Participants received single dose of placebo matched to bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks. | | OG003 | Bococizumab 75 mg |
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug up to the follow up visit (up to 18 weeks), that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. | Safety analysis set included all participants who received at least one dose of study medication. | Posted | | Number | | participants | | Baseline up to 18 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo Matched to Bococizumab 150 mg | Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks. | | OG001 | Bococizumab 150 mg | Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks. | |
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| Secondary | Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) | Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. Participants with their ADA titer levels >=6.23 were considered as ADA positive and participants with their nAb titer level >=1.58 were considered as nAb positive. | Safety analysis set included all participants who received at least 1 dose of study treatment. Participants who received at least 1 dose of bococizumab were evaluable for this outcome measure. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | Baseline up to 18 weeks | | | | ID | Title | Description |
|---|
| OG000 | Bococizumab 150 mg | Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks. | | OG001 | Bococizumab 75 mg | Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks. |
| |
| Secondary | Plasma Concentration of Bococizumab at Week 12 | | Analysis set included all participants who received at least one dose of study medication. Participants who received at least 1 dose of Bococizumab were evaluable for this outcome measure. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | microgram per milliliter | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Bococizumab 150 mg | Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks. | | OG001 | Bococizumab 75 mg | Participants received single dose of bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks. |
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| Secondary | Plasma Concentration of Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) at Week 12 | PCSK9 is an enzyme encoded by the PCSK9 gene in humans on chromosome. It is the 9th member of the proprotein convertase family of proteins that activate other proteins. | Safety analysis set included all participants who received at least 1 dose of study treatment. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | nanogram per milliliter | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Matched to Bococizumab 150 mg | Participants received single dose of placebo matched to bococizumab 150 milligram (mg) subcutaneous injection once in every 2 weeks over a period of 12 weeks. Participants were followed up to 18 weeks. | | OG001 | Bococizumab 150 mg | Participants received single dose of bococizumab 150 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks. | | OG002 | Placebo Matched to Bococizumab 75 mg | Participants received single dose of placebo matched to bococizumab 75 mg subcutaneous injection once in every 2 weeks, over a period of 12 weeks. Participants were followed up to 18 weeks. |
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