| Primary | Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: ([LDL-C value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100. Bempedoic Acid = BA. Percent change from Baseline in LDL-C was analyzed using an analysis of covariance (ANCOVA) model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate. In the ANCOVA model, missing LDL-C data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment. | Full Analysis Set: all randomized participants | Posted | | Least Squares Mean | Standard Error | percent change | | Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. | | OG001 | Bempedoic Acid | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0004.99± 2.299
- OG001-23.46± 1.945
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | ANCOVA | | <0.001 | | Difference in LS mean | -28.45 | Standard Error of the Mean | 3.022 | 2-Sided | 95 | -34.376 | -22.531 | | | | | Superiority | | |
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| Secondary | Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analysed for non-HDL-C. Baseline was defined as the mean of the non-HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: ([non-HDL-C value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100. Percent change from Baseline in non-HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate. In the ANCOVA model, missing non-HDL-C data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment. | | Posted | | Least Squares Mean | Standard Error | percent change | | Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. | | OG001 | Bempedoic Acid | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. |
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| Secondary | Percent Change From Baseline to Week 12 in Total Cholesterol (TC) | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analysed for TC. Baseline was defined as the mean of the TC values from the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: ([TC value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100. Percent change from Baseline in TC was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate. In the ANCOVA model, missing TC data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment. | | Posted | | Least Squares Mean | Standard Error | Percent change | | Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. | | OG001 | Bempedoic Acid | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. |
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| Secondary | Percent Change From Baseline to Week 12 in Apolipoprotein B (apoB) | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analysed for apoB. Baseline was defined as the last non-missing value on or prior to Day 1. Percent change from baseline was calculated as: [(apoB value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Percent change from Baseline in apoB was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate. In the ANCOVA model, missing apoB data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment. | | Posted | | Least Squares Mean | Standard Error | Percent change | | Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. | | OG001 | Bempedoic Acid | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. |
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| Secondary | Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analysed for hsCRP. Baseline was defined as the last non-missing value on or prior to Day 1. Percent change from baseline was calculated as: [(hsCRP value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100. | Full Analysis Set. Only participants with available data were analyzed. | Posted | | Median | Inter-Quartile Range | Percent change | | Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. | | OG001 | Bempedoic Acid | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. |
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| Secondary | Percent Change From Baseline to Week 12 in Triglycerides (TGs) | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for TGs. Baseline was defined as the mean of the TGs values from the last two non-missing values on or prior to D 1. Percent change from baseline was calculated as: [(TGs value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Percent change from Baseline in TGs was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate. | Full Analysis Set. Only participants with available data were analyzed. | Posted | | Least Squares Mean | Standard Error | Percent change | | Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. | | OG001 | Bempedoic Acid | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. |
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| Secondary | Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C) | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for HDL-C. Baseline was defined as the mean of the HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: [(HDL-C value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Percent change from Baseline in HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate. | Full Analysis Set. Only participants with available data were analyzed. | Posted | | Least Squares Mean | Standard Error | percent change | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. | | OG001 | Bempedoic Acid | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAEs, defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. | Safety Analysis Set: all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group that they actually received, regardless of their randomized treatment. | Posted | | Number | | Participants | | Up to approximately 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. | | OG001 | Bempedoic Acid | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. |
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| Other Pre-specified | Percent Change From Baseline to Weeks 4 and 8 in LDL-C | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: [(LDL-C value at Week 4 or 8 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Percent change from Baseline in LDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate. | Full Analysis Set. Only participants with available data were analyzed. | Posted | | Least Squares Mean | Standard Error | Percent change | | Week 4 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. | | OG001 | Bempedoic Acid | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. |
|
| Other Pre-specified | Percent Change From Baseline to Weeks 4 and 8 in Non-HDL-C | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for Non-HDL-C. Baseline was defined as the mean of the Non-HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: [(Non-HDL-C value at Week 4 or 8 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Percent change from Baseline in non-HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate. | Full Analysis Set. Only participants with available data were analyzed. | Posted | | Least Squares Mean | Standard Error | Percent change | | Week 4 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. | | OG001 | Bempedoic Acid | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. |
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| Other Pre-specified | Percent Change From Baseline to Weeks 4 and 8 in TC | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for TC. Baseline was defined as the mean of the TC values from the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: [(TC value at Week 4 or 8 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Percent change from Baseline in TC was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate. | Full Analysis Set. Only participants with available data were analyzed. | Posted | | Least Squares Mean | Standard Error | Percent change | | Week 4 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. | | OG001 | Bempedoic Acid | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. |
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| Other Pre-specified | Percent Change From Baseline to Weeks 4 and 8 in TGs | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analysed for TGs. Baseline was defined as the mean of the TGs values from the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: [(TGs value at Week 4 or 8 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Percent change from Baseline in TGs was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate. | Full Analysis Set. Only participants with available data were analyzed. | Posted | | Least Squares Mean | Standard Error | Percent change | | Week 4 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. | | OG001 | Bempedoic Acid | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. |
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| Other Pre-specified | Percent Change From Baseline to Weeks 4 and 8 in HDL-C | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analysed for HDL-C. Baseline was defined as the mean of the HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: [(HDL-C value at Week 4 or 8 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Percent change from Baseline in HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate. | Full Analysis Set. Only participants with available data were analyzed. | Posted | | Least Squares Mean | Standard Error | Percent change | | Week 4 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. | | OG001 | Bempedoic Acid | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. |
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| Other Pre-specified | Absolute Change From Baseline to Weeks 4, 8, and 12 in LDL-C | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analysed for LDL-C. Baseline was defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Absolute change from baseline was calculated as: LDL-C value at Week 4, 8, or 12 minus Baseline value. | Full Analysis Set. Only participants with available data were analyzed. | Posted | | Geometric Mean | Standard Deviation | milligrams per deciliter (mg/dL) | | Week 4, Week 8 and Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. | | OG001 | Bempedoic Acid | Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks. |
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