| Primary | Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) to Week 6 | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week -1 and Week 0. Percent change from Baseline in LDL-C was analyzed using an analysis of covariance (ANCOVA) model with a term for treatment and Baseline value as a covariate. The Week 6 endpoint was the last available post-Baseline value. For the Week 6 endpoint, missing values at Week 6 were imputed using the last observation carried forward (LOCF) procedure, with only post-Baseline values carried forward. Modified Intent-to-Treat (mITT) Population is defined as all randomized participants who received at least 1 dose of study drug, had a Baseline assessment, and had at least 1 post-Baseline assessment, excluding any assessment taken more than 2 days after a dose of study drug | mITT Population. Only participants with available data were analyzed. | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline; 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received matching oral placebo capsules taken once daily for 6 weeks. | | OG001 | ETC-1002 180 mg | Participants received oral bempedoic acid 180 milligrams (mg) daily for 6 weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0003.16± 2.133
- OG001-21.08± 2.196
|
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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 | | <0.0001 | | Least squares mean difference | -24.24 | Standard Error of the Mean | 3.080 | 2-Sided | 95 | -30.33 | -18.15 | | | The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm. | | Superiority | | |
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| Secondary | Change From Baseline in Mean 24-hour Systolic Blood Pressure (SBP) to Week 6 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the last value prior to the first dose of study medication. Change from Baseline was calculated using an ANCOVA model with a term for treatment and Baseline value as a covariate. The Week 6 endpoint was the last available post-Baseline value. | mITT Population. Only participants with available data were analyzed. | Posted | | Least Squares Mean | Standard Error | millimeters of mercury (mmHg) | | Baseline; 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received matching oral placebo capsules taken once daily for 6 weeks. | | OG001 | ETC-1002 180 mg | Participants received oral bempedoic acid 180 mg daily for 6 weeks. |
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| Secondary | Change From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) to Week 6 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the last value prior to the first dose of study medication. Change from Baseline was calculated using an ANCOVA model with a term for treatment and Baseline value as a covariate. The Week 6 endpoint was the last available post-Baseline value. | mITT Population. Only participants with available data were analyzed. | Posted | | Least Squares Mean | Standard Deviation | mmHg | | Baseline; 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received matching oral placebo capsules taken once daily for 6 weeks. | | OG001 | ETC-1002 180 mg | Participants received oral bempedoic acid 180 milligrams (mg) daily for 6 weeks. |
| |
| Secondary | Change From Baseline in Mean Daytime SBP to Week 6 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the last value prior to the first dose of study medication. Change from Baseline was calculated using an ANCOVA model with a term for treatment and Baseline value as a covariate. Daytime measurements were defined as those taken from 7 AM to 10 PM (>7 AM and ≤10 PM). The Week 6 endpoint was the last available post-Baseline value. | mITT Population. Only participants with available data were analyzed. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline; 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received matching oral placebo capsules taken once daily for 6 weeks. | | OG001 | ETC-1002 180 mg | Participants received oral bempedoic acid 180 mg daily for 6 weeks. |
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| Secondary | Change From Baseline in Mean Daytime DBP to Week 6 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the last value prior to the first dose of study medication. Change from Baseline was calculated using an ANCOVA model with a term for treatment and Baseline value as a covariate. Daytime measurements were defined as those taken from 7 AM to 10 PM (>7 AM and ≤10 PM). The Week 6 endpoint was the last available post-Baseline value. | mITT Population. Only participants with available data were analyzed. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline; 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received matching oral placebo capsules taken once daily for 6 weeks. | | OG001 | ETC-1002 180 mg | Participants received oral bempedoic acid 180 mg daily for 6 weeks. |
| |
| Secondary | Change From Baseline in Mean Nighttime SBP to Week 6 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the last value prior to the first dose of study medication. Change from Baseline was calculated using an ANCOVA model with a term for treatment and Baseline value as a covariate. Nighttime measurements were defined as those taken from 10 PM to 7 AM (>10 PM and ≤7 AM). The Week 6 endpoint was the last available post-Baseline value. | mITT Population. Only participants with available data were analyzed. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline; 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received matching oral placebo capsules taken once daily for 6 weeks. | | OG001 | ETC-1002 180 mg | Participants received oral bempedoic acid 180 mg daily for 6 weeks. |
| |
| Secondary | Change From Baseline in Mean Nighttime DBP to Week 6 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the last value prior to the first dose of study medication. Change from Baseline was calculated using an ANCOVA model with a term for treatment and Baseline value as a covariate. Nighttime measurements were defined as those taken from 10 PM to 7 AM (>10 PM and ≤7 AM). The Week 6 endpoint was the last available post-Baseline value. | mITT Population. Only participants with available data were analyzed. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline; 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received matching oral placebo capsules taken once daily for 6 weeks. | | OG001 | ETC-1002 180 mg | Participants received oral bempedoic acid 180 mg daily for 6 weeks. |
| |
| Secondary | Change From Baseline in Sitting Cuff SBP to Week 6 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the mean of the values from Weeks -1 and 0. Change from Baseline was calculated using an ANCOVA model with a term for treatment and Baseline value as a covariate. Three BP measurements were collected at least 3 minutes apart, and the mean of the second and third measurements was calculated and used for summary and analysis. The Week 6 endpoint was the last available post-Baseline value. | mITT Population. Only participants with available data were analyzed. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline: 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received matching oral placebo capsules taken once daily for 6 weeks. | | OG001 | ETC-1002 180 mg | Participants received oral bempedoic acid 180 mg daily for 6 weeks. |
| |
| Secondary | Change From Baseline in Sitting Cuff DBP to Week 6 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the mean of the values from Weeks -1 and 0. Change from Baseline was calculated using an ANCOVA model with a term for treatment and Baseline value as a covariate. Three BP measurements were collected at least 3 minutes apart, and the mean of the second and third measurements was calculated and used for summary and analysis. The Week 6 endpoint was the last available post-Baseline value. | mITT Population. Only participants with available data were analyzed. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline; 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received matching oral placebo capsules taken once daily for 6 weeks. | | OG001 | ETC-1002 180 mg | Participants received oral bempedoic acid 180 mg daily for 6 weeks. |
| |
| Secondary | Percent Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) to Week 6 | A non-parametric analysis was performed for hsCRP parameters. Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the last value prior to the first dose of study medication. If hsCRP was <0.2, 0.1 was imputed for analysis. The Week 6 endpoint was the last available post-Baseline value. | miTT Population. Only participants with available data were analyzed. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline; 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received matching oral placebo capsules taken once daily for 6 weeks. | | OG001 | ETC-1002 180 mg | Participants received oral bempedoic acid 180 mg daily for 6 weeks. |
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| Secondary | Percent Change From Baseline in Total Cholesterol to Week 6 | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week -1 and Week 0. Change from Baseline was calculated using an ANCOVA model with terms for treatment and statin intolerance, and value as a covariate. The Week 6 endpoint was the last available post-Baseline value. | mITT Population. Only participants with available data were analyzed. | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline; 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received matching oral placebo capsules taken once daily for 6 weeks. | | OG001 | ETC-1002 180 mg | Participants received oral bempedoic acid 180 mg daily for 6 weeks. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein B (ApoB) to Week 6 | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week -1 and Week 0. Change from Baseline was calculated using an ANCOVA model with terms for treatment and statin intolerance, and Baseline value as a covariate. The Week 6 endpoint was the last available post-Baseline value. | mITT Population. Only participants with available data were analyzed. | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline; 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received matching oral placebo capsules taken once daily for 6 weeks. | | OG001 | ETC-1002 180 mg | Participants received oral bempedoic acid 180 mg daily for 6 weeks. |
| |
| Secondary | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) to Week 6 | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the last value prior to the first dose of study medication. Change from Baseline was calculated using an ANCOVA model with a term for treatment and Baseline value as a covariate. The Week 6 endpoint was the last available post-Baseline value. | mITT Population. Only participants with available data were analyzed. | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline; 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received matching oral placebo capsules taken once daily for 6 weeks. | | OG001 | ETC-1002 180 mg | Participants received oral bempedoic acid 180 mg daily for 6 weeks. |
| |
| Secondary | Percent Change From Baseline in Triglycerides (TG) to Week 6 | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week -1 and Week 0. The Week 6 endpoint was the last available post-Baseline value. Data was analyzed using non-parametric analysis. | mITT Population. Only participants with available data were analyzed. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline; 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received matching oral placebo capsules taken once daily for 6 weeks. | | OG001 | ETC-1002 180 mg | Participants received oral bempedoic acid 180 mg daily for 6 weeks. |
| |
| Secondary | Percent Change From Baseline in HDL-C to Week 6 | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week -1 and Week 0. Change from Baseline was calculated using an ANCOVA model with terms for treatment and statin intolerance, and Baseline value as a covariate. The Week 6 endpoint was the last available post-Baseline value. | mITT Population. Only participants with available data were analyzed. | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline; 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received matching oral placebo capsules taken once daily for 6 weeks. | | OG001 | ETC-1002 180 mg | Participants received oral bempedoic acid 180 mg daily for 6 weeks. |
| |
| Secondary | Percent Change From Baseline in Free Fatty Acids (FFA) to Week 6 | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week -1 and Week 0. The Week 6 endpoint was the last available post-Baseline value. | mITT Population. Only participants with available data were analyzed. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline; 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received matching oral placebo capsules taken once daily for 6 weeks. | | OG001 | ETC-1002 180 mg | Participants received oral bempedoic acid 180 mg daily for 6 weeks. |
| |
| Secondary | Change From Baseline in Body Weight to Week 6 | Baseline was defined as the mean of the values from Week -1 and Week 0. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Safety Population: all randomized participants who received at least 1 dose of study drug. Only participants with available data were analyzed. | Posted | | Mean | Standard Deviation | kilograms | | Baseline; 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received matching oral placebo capsules taken once daily for 6 weeks. | | OG001 | ETC-1002 180 mg | Participants received oral bempedoic acid 180 mg daily for 6 weeks. |
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| Secondary | Plasma Trough Concentrations of ETC-1002 and Metabolite ESP15228 | Plasma trough concentration is defined as the lowest concentration reached before the next dose is administered. | Pharmacokinetic Concentration Population: all randomized participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration value for study drug collected between 18 and 36 hours post-dose. Only participants with available data were analyzed. | Posted | | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | | Week 2, Week 4 and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | ETC-1002 180 mg | Participants received oral bempedoic acid 180 mg daily for 6 weeks. |
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