Trial · NCT02991118
Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk
NCT02991118, Phase 3, Completed, Esperion Therapeutics, Inc.; results first posted 2020-04-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk. Trials, record NCT02991118. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02991118
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk
- NCT number
- NCT02991118
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 779 participants, actual
- Lead sponsor
- Esperion Therapeutics, Inc.
- Conditions
- Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
- Interventions
- bempedoic acid, placebo
- First posted
- 2016-12-13
- Last updated
- 2020-04-27
- Other registries' IDs
- eudract:2016-003486-26
- Results first posted
- 2020-04-27
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C) | Baseline; Week 12 | Baseline is 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 is calculated as (\[post-baseline value minus baseline value\] divided by \[baseline value\]) multiplied by 100. 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, cardiovascular risk (atherosclerotic cardiovascular diseases \[ASCVD\] and heterozygous familial hypercholesterolemia \[HeFH\]) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate. In the ANCOVA model, missing LDL-C data at Week 12 are imputed using multiple imputation method taking into account adherence to treatment. |
| Secondary | Percent Change From Baseline to Week 24 in LDL-C | Baseline; Week 24 | Baseline is 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 is calculated as (\[post-baseline value minus baseline value\] 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, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate. In the ANCOVA model, missing LDL-C data at Week 24 were imputed using multiple imputation method taking into account adherence to treatment. |
| Secondary | Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Baseline; Week 12 | Baseline is 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 is calculated as (\[post-baseline value minus baseline value\] 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, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as 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. |
| Secondary | Percent Change From Baseline to Week 12 in Total Cholesterol (TC) | Baseline; Week 12 | Baseline is 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 is calculated as (\[post-baseline value minus baseline value\] 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, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as 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. |
| Secondary | Percent Change From Baseline to Week 12 in Apolipoprotein b (Apo B) | Baseline; Week 12 | Baseline for apo B was defined as the last non-missing value on or prior to Day 1. Percent change from Baseline is calculated as (\[post-baseline value minus baseline value\] divided by \[baseline value\]) multiplied by 100. Percent change from Baseline in apo B was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate. In the ANCOVA model, missing apo B data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment. |
| Secondary | Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) | Baseline; Week 12 | Baseline for hsCRP was defined as the last non-missing value on or prior to Day 1. Percent change from Baseline is calculated as (\[post-baseline value minus baseline value\] divided by \[baseline value\]) multiplied by 100. |
| Secondary | Change From Baseline to Week 12 in LDL-C | Baseline; Week 12 | Baseline is defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Change from Baseline is calculated as the post-baseline value minus the baseline value. Analysis was conducted using descriptive statistics by treatment group using observed data. |
| Secondary | Change From Baseline to Week 24 in LDL-C | Baseline; Week 24 | Baseline is defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Change from Baseline is calculated as the post-baseline value minus the baseline value. Analysis was conducted using descriptive statistics by treatment group using observed data. |
| Other | Percent Change From Baseline to Week 12 in Triglycerides (TGs) | Baseline; Week 12 | Baseline is defined as the mean of the TG values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as (\[post-baseline value minus baseline value\] divided by \[baseline value\]) multiplied by 100. Percent change from Baseline in TG was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate. |
| Other | Percent Change From Baseline to Week 12 in HDL-C | Baseline; Week 12 | Baseline is 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 is calculated as (\[post-baseline value minus baseline value\] 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, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C) | Baseline; Week 12 | Full Analysis Set: all randomized participants | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 24 in LDL-C | Baseline; Week 24 | Full Analysis Set: all randomized participants | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Baseline; Week 12 | Full Analysis Set: all randomized participants | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 12 in Total Cholesterol (TC) | Baseline; Week 12 | Full Analysis Set: all randomized participants | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 12 in Apolipoprotein b (Apo B) | Baseline; Week 12 | Full Analysis Set: all randomized participants | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) | Baseline; Week 12 | Full Analysis Set. Only participants with available data were analyzed. | percent change | MEDIAN |
| SECONDARY | Change From Baseline to Week 12 in LDL-C | Baseline; Week 12 | Full Analysis Set. Only participants with available data were analyzed. | mg/dL | MEAN |
| SECONDARY | Change From Baseline to Week 24 in LDL-C | Baseline; Week 24 | Full Analysis Set. Only participants with available data were analyzed. | mg/dL | MEAN |
| OTHER_PRE_SPECIFIED | Percent Change From Baseline to Week 12 in Triglycerides (TGs) | Baseline; Week 12 | Full Analysis Set. Only participants with available data were analyzed. | percent change | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Percent Change From Baseline to Week 12 in HDL-C | Baseline; Week 12 | Full Analysis Set. Only participants with available data were analyzed. | percent change | LEAST_SQUARES_MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C) | Placebo | 2.35 | Standard Error 1.446 | percent change | |
| Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C) | Bempedoic Acid | -15.07 | Standard Error 1.073 | percent change | |
| Percent Change From Baseline to Week 24 in LDL-C | Placebo | 2.66 | Standard Error 1.910 | percent change | |
| Percent Change From Baseline to Week 24 in LDL-C | Bempedoic Acid | -12.10 | Standard Error 1.479 | percent change | |
| Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Placebo | 2.28 | Standard Error 1.351 | percent change | |
| Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Bempedoic Acid | -10.75 | Standard Error 0.952 | percent change | |
| Percent Change From Baseline to Week 12 in Total Cholesterol (TC) | Placebo | 1.26 | Standard Error 1.010 | percent change | |
| Percent Change From Baseline to Week 12 in Total Cholesterol (TC) | Bempedoic Acid | -9.94 | Standard Error 0.688 | percent change | |
| Percent Change From Baseline to Week 12 in Apolipoprotein b (Apo B) | Placebo | 3.73 | Standard Error 1.340 | percent change | |
| Percent Change From Baseline to Week 12 in Apolipoprotein b (Apo B) | Bempedoic Acid | -9.29 | Standard Error 0.851 | percent change |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 257 | |
| Overall Study | STARTED | Bempedoic Acid | 522 | |
| Overall Study | COMPLETED | Placebo | 250 | |
| Overall Study | COMPLETED | Bempedoic Acid | 490 | |
| Overall Study | NOT COMPLETED | Placebo | 7 | |
| Overall Study | NOT COMPLETED | Bempedoic Acid | 32 |
Source ClinicalTrials.gov
Adverse events286
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 3 | 257 | |
| other | Anaemia | Blood and lymphatic system disorders | Bempedoic Acid | 14 | 522 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 7 | 257 | |
| other | Diarrhoea | Gastrointestinal disorders | Bempedoic Acid | 16 | 522 | |
| other | Fatigue | General disorders | Placebo | 9 | 257 | |
| other | Fatigue | General disorders | Bempedoic Acid | 6 | 522 | |
| other | Bronchitis | Infections and infestations | Placebo | 6 | 257 | |
| other | Bronchitis | Infections and infestations | Bempedoic Acid | 7 | 522 | |
| other | Lower respiratory tract infection | Infections and infestations | Placebo | 7 | 257 | |
| other | Lower respiratory tract infection | Infections and infestations | Bempedoic Acid | 7 | 522 |
1 to 10 of 286Source ClinicalTrials.gov
See all 286 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 2 | 257 |
| Total, all-cause mortality | Bempedoic Acid | 6 | 522 |
| Total, other adverse events | Placebo | 88 | 257 |
| Total, other adverse events | Bempedoic Acid | 211 | 522 |
| Total, serious adverse events | Placebo | 48 | 257 |
| Total, serious adverse events | Bempedoic Acid | 106 | 522 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Bempedoic Acid vs Placebo: deaths from any cause | Trial comparisons |
| Bempedoic Acid vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02991118
GET https://conductscience.org/api/trials/v1/NCT02991118/results?page=2