| Primary | Percent Change From Baseline to Week 12 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C) | 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 Weeks -1 and 0. Least square (LS) mean percent change from Baseline to Week 12 was based on an analysis of covariance (ANCOVA) model with effects of treatment and triglyceride (TG) stratum and Baseline value as a covariate. Missing LDL-C values at Week 12 were imputed using the last observation carried forward (LOCF) procedure (only post-Baseline values were carried forward). | Modified Intent-to-Treat (mITT) Population: all randomized participants who received at least 1 dose of study medication and had a Baseline assessment and at least 1 post-Baseline assessment, excluding any assessments taken more than 2 days after a dose of study medication | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline; 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | ETC-1002 40 mg | Participants received ETC-1002 40 milligrams (mg), orally, once daily for 12 weeks. | | OG001 | ETC-1002 80 mg | Participants received ETC-1002 80 mg, orally, once daily for 12 weeks. | | OG002 | ETC-1002 120 mg | Participants received ETC-1002 120 mg, orally, once daily for 12 weeks. | | OG003 | Placebo | Participants received placebo, orally, once daily for 12 weeks. |
| | Units | Counts |
|---|
| Participants | - OG00042
- OG00144
- OG00242
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-17.9± 2.17
- OG001-25.0± 2.12
- OG002-26.6± 2.16
- 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 |
|---|
| | ANCOVA | | <0.0001 | | Difference in Least Squares Means | -15.7 | | | 2-Sided | 95 | -21.8 | -9.7 | | | | | Superiority | | | | | ANCOVA | | <0.0001 | |
|
| Primary | Percent Change From Baseline to Week 12 in LDL-C by Triglyceride (TG) Stratum | 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 Weeks -1 and 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and center and Baseline value as a covariate. Missing LDL-C values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward). | | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline; 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | ETC-1002 40 mg | Participants received ETC-1002 40 mg, orally, once daily for 12 weeks. | | OG001 | ETC-1002 80 mg | Participants received ETC-1002 80 mg, orally, once daily for 12 weeks. | | OG002 | ETC-1002 120 mg | Participants received ETC-1002 120 mg, orally, once daily for 12 weeks. | | OG003 | Placebo | |
|
| Secondary | Percent Change From Baseline to Week 12 in TG | 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 Weeks -1 and 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing TG values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward). | | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline; 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | ETC-1002 40 mg | Participants received ETC-1002 40 mg, orally, once daily for 12 weeks. | | OG001 | ETC-1002 80 mg | Participants received ETC-1002 80 mg, orally, once daily for 12 weeks. | | OG002 | ETC-1002 120 mg | Participants received ETC-1002 120 mg, orally, once daily for 12 weeks. | | OG003 | Placebo | |
|
| Secondary | Percent Change From Baseline to Week 12 in High-Density Lipoprotein-Cholesterol (HDL-C) | 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 Weeks -1 and 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing HDL-C values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward). | | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline; 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | ETC-1002 40 mg | Participants received ETC-1002 40 mg, orally, once daily for 12 weeks. | | OG001 | ETC-1002 80 mg | Participants received ETC-1002 80 mg, orally, once daily for 12 weeks. | | OG002 | ETC-1002 120 mg | Participants received ETC-1002 120 mg, orally, once daily for 12 weeks. | | OG003 | Placebo | |
|
| Secondary | Percent Change From Baseline to Week 12 in Non-HDL-C | 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 Weeks -1 and 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing non-HDL-C values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward). | | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline; 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | ETC-1002 40 mg | Participants received ETC-1002 40 mg, orally, once daily for 12 weeks. | | OG001 | ETC-1002 80 mg | Participants received ETC-1002 80 mg, orally, once daily for 12 weeks. | | OG002 | ETC-1002 120 mg | Participants received ETC-1002 120 mg, orally, once daily for 12 weeks. | | OG003 | Placebo | |
|
| Secondary | Percent Change From Baseline to Week 12 in Total Cholesterol (TC) | 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 Weeks -1 and 0. LS mean percent change from Baseline to Week 12 based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing TC values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward). | | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline; 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | ETC-1002 40 mg | Participants received ETC-1002 40 mg, orally, once daily for 12 weeks. | | OG001 | ETC-1002 80 mg | Participants received ETC-1002 80 mg, orally, once daily for 12 weeks. | | OG002 | ETC-1002 120 mg | Participants received ETC-1002 120 mg, orally, once daily for 12 weeks. | | OG003 | Placebo | |
|
| Secondary | Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB) | 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 value from Week 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing ApoB values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward). | mITT Population. Only participants with available data were analyzed. | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline; 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | ETC-1002 40 mg | Participants received ETC-1002 40 mg, orally, once daily for 12 weeks. | | OG001 | ETC-1002 80 mg | Participants received ETC-1002 80 mg, orally, once daily for 12 weeks | | OG002 | ETC-1002 120 mg | Participants received ETC-1002 120 mg, orally, once daily for 12 weeks. | | OG003 | Placebo |
|
| Secondary | Percent Change From Baseline to Week 12 in Apolipoprotein AI (ApoAI) | 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 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing ApoAI values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward). | mITT Population. Only participants with available data were analyzed. | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline; 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | ETC-1002 40 mg | Participants received ETC-1002 40 mg, orally, once daily for 12 weeks. | | OG001 | ETC-1002 80 mg | Participants received ETC-1002 80 mg, orally, once daily for 12 weeks. | | OG002 | ETC-1002 120 mg | Participants received ETC-1002 120 mg, orally, once daily for 12 weeks. | | OG003 | Placebo |
|
| Secondary | Percent Change From Baseline to Week 12 in Lipoprotein (a) | 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 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing Lipoprotein (a) values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward). | mITT Population. Only participants with available data were analyzed. | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline; 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | ETC-1002 40 mg | Participants received ETC-1002 40 mg, orally, once daily for 12 weeks. | | OG001 | ETC-1002 80 mg | Participants received ETC-1002 80 mg, orally, once daily for 12 weeks. | | OG002 | ETC-1002 120 mg | Participants received ETC-1002 120 mg, orally, once daily for 12 weeks. | | OG003 | Placebo |
|
| Secondary | Percent Change From Baseline to Week 12 in Free Fatty Acids (FFA) | 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 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing FFA values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward). | mITT Population. Only participants with available data were analyzed. | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline; 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | ETC-1002 40 mg | Participants received ETC-1002 40 mg, orally, once daily for 12 weeks. | | OG001 | ETC-1002 80 mg | Participants received ETC-1002 80 mg, orally, once daily for 12 weeks. | | OG002 | ETC-1002 120 mg | Participants received ETC-1002 120 mg, orally, once daily for 12 weeks. | | OG003 | Placebo |
|
| Secondary | Percent Change From Baseline to Week 12 in High-Sensitivity C-Reactive Protein (hsCRP) | 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 value from Week 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing hsCRP values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward). | mITT Population. Only participants with available data were analyzed. | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline; 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | ETC-1002 40 mg | Participants received ETC-1002 40 mg, orally, once daily for 12 weeks. | | OG001 | ETC-1002 80 mg | Participants received ETC-1002 80 mg, orally, once daily for 12 weeks. | | OG002 | ETC-1002 120 mg | Participants received ETC-1002 120 mg, orally, once daily for 12 weeks. | | OG003 | Placebo |
|
| Secondary | Percent Change From Baseline to Week 12 in Total LDL Particles | 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 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward). | mITT Population. Only participants with available date were analyzed. | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline; 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | ETC-1002 40 mg | Participants received ETC-1002 40 mg, orally, once daily for 12 weeks. | | OG001 | ETC-1002 80 mg | Participants received ETC-1002 80 mg, orally, once daily for 12 weeks. | | OG002 | ETC-1002 120 mg | Participants received ETC-1002 120 mg, orally, once daily for 12 weeks. | | OG003 | Placebo |
|
| Secondary | Percent Change From Baseline to Week 12 in Total HDL Particles | 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 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward). | mITT Population. Only participants with available data were analyzed. | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline; 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | ETC-1002 40 mg | Participants received ETC-1002 40 mg, orally, once daily for 12 weeks. | | OG001 | ETC-1002 80 mg | Participants received ETC-1002 80 mg, orally, once daily for 12 weeks. | | OG002 | ETC-1002 120 mg | Participants received ETC-1002 120 mg, orally, once daily for 12 weeks. | | OG003 | Placebo |
|
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAEs were defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication. | Safety Population: all randomized participants who received at least 1 dose of study medication | Posted | | Count of Participants | | Participants | | up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | ETC-1002 40 mg | Participants received ETC-1002 40 mg, orally, once daily for 12 weeks. | | OG001 | ETC-1002 80 mg | Participants received ETC-1002 80 mg, orally, once daily for 12 weeks. | | OG002 | ETC-1002 120 mg | Participants received ETC-1002 120 mg, orally, once daily for 12 weeks. | | OG003 | Placebo | Participants received placebo, orally, once daily for 12 weeks. |
| |
| Secondary | Number of Participants With Clinically Significant Physical Examination Findings | Clinical significance was determined by the investigator. | | Posted | | Count of Participants | | Participants | | up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | ETC-1002 40 mg | Participants received ETC-1002 40 mg, orally, once daily for 12 weeks. | | OG001 | ETC-1002 80 mg | Participants received ETC-1002 80 mg, orally, once daily for 12 weeks. | | OG002 | ETC-1002 120 mg | Participants received ETC-1002 120 mg, orally, once daily for 12 weeks. | | OG003 | Placebo | Participants received placebo, orally, once daily for 12 weeks. |
| |
| Secondary | Number of Participants With Clinically Important Changes From Baseline in Vital Sign Values | Clinical importance was determined by the investigator. | | Posted | | Count of Participants | | Participants | | Baseline; up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | ETC-1002 40 mg | Participants received ETC-1002 40 mg, orally, once daily for 12 weeks. | | OG001 | ETC-1002 80 mg | Participants received ETC-1002 80 mg, orally, once daily for 12 weeks. | | OG002 | ETC-1002 120 mg | Participants received ETC-1002 120 mg, orally, once daily for 12 weeks. | | OG003 | Placebo | Participants received placebo, orally, once daily for 12 weeks. |
| |
| Secondary | Number of Participants With Clinically Important Changes From Baseline in Electrocardiogram Values | Clinical importance was determined by the investigator. | | Posted | | Count of Participants | | Participants | | Baseline; up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | ETC-1002 40 mg | Participants received ETC-1002 40 mg, orally, once daily for 12 weeks. | | OG001 | ETC-1002 80 mg | Participants received ETC-1002 80 mg, orally, once daily for 12 weeks. | | OG002 | ETC-1002 120 mg | Participants received ETC-1002 120 mg, orally, once daily for 12 weeks. | | OG003 | Placebo | Participants received placebo, orally, once daily for 12 weeks. |
| |
| Secondary | Number of Participants With the Indicated Abnormal Laboratory Parameter Values at Week 12 | Laboratory abnormalities are laboratory values that are outside the normal range. | Safety Population. Only participants with available data were analyzed. | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | ETC-1002 40 mg | Participants received ETC-1002 40 mg, orally, once daily for 12 weeks. | | OG001 | ETC-1002 80 mg | Participants received ETC-1002 80 mg, orally, once daily for 12 weeks.. | | OG002 | ETC-1002 120 mg | Participants received ETC-1002 120 mg, orally, once daily for 12 weeks. | | OG003 | Placebo | Participants received placebo, orally, once daily for 12 weeks. |
| |