Trial · NCT02988115
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant
NCT02988115, Phase 3, Completed, Esperion Therapeutics, Inc.; results first posted 2020-04-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant. Trials, record NCT02988115. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02988115
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant
- NCT number
- NCT02988115
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 345 participants, actual
- Lead sponsor
- Esperion Therapeutics, Inc.
- Conditions
- Hypercholesterolemia, Atherosclerotic Cardiovascular Disease, Statin Adverse Reaction
- Interventions
- bempedoic acid, placebo
- First posted
- 2016-12-09
- Last updated
- 2020-04-03
- Results first posted
- 2020-04-03
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline (PCFB) in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline; Week 12 | PCFB was calculated as the (\[post-Baseline (BL) value minus the BL value\] divided by the BL value ) x 100. BL was defined as the mean of the last two non-missing values on or prior to Day 1. If only one value was available, that single value was used as BL. PCFB in LDL-C was analyzed using analysis of covariance (ANCOVA), with treatment group and stratification factor (primary prevention; secondary prevention) as fixed effects and BL as a covariate. For participants with missing lipid data at Week 12 who were no longer taking study treatment, missing values were imputed using multiple imputation via a regression-based model including stratification and BL data from placebo participants only. In this imputation model, treatment group was not included. For participants with missing lipid data at Week 12 who were still taking study treatment, missing values were imputed using multiple imputation via a regression-based model including treatment, stratification and BL value. |
| Secondary | Percent Change From Baseline in LDL-C at Week 24 | Baseline; Week 24 | PCFB was calculated as the (\[post-BL value minus the BL value\] divided by the BL value ) x 100. BL was defined as the mean of the last two non-missing values on or prior to Day 1. If only one value was available then that single value was used as BL. PCFB in LDL-C was analyzed using ANCOVA, with treatment group and stratification factor (primary prevention; secondary prevention) as fixed effects and BL as a covariate. For participants with missing lipid data at Week 12 who were no longer taking study treatment, missing values were imputed using multiple imputation via a regression-based model including stratification and BL data from placebo participants only. In this imputation model, treatment group was not included. For participants with missing lipid data at Week 12 who were still taking study treatment, missing values were imputed using multiple imputation via a regression-based model including treatment, stratification and BL value. |
| Secondary | Percent Change From Baseline in the Lipid Profile at Week 12 | Baseline; Week 12 | PCFB was calculated as: (\[post-BL value minus the BL value\] divided by the BL value) x 100. BL was defined as the mean of the last two non-missing values on or prior to Day 1. If only one value was available, that single value was used as BL. apoB and TC BL were defined as the last non-missing value on/prior to Day 1. PCFB was analyzed using ANCOVA, with treatment and group stratification factor (primary prevention; secondary prevention) as fixed effects and BL as a covariate. For participants with missing data at Week 12 who were no longer taking study treatment (ST), missing values were imputed using multiple imputation via a regression-based model including stratification and BL data from placebo participants only. In this imputation model, treatment group was not included. For participants with missing lipid data at Week 12 who were still taking ST, missing values were imputed using multiple imputation via a regression-based model including treatment, stratification and BL value. |
| Secondary | Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 12 | Baseline; Week 12 | Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline for hsCRP is defined as the last non-missing value on or prior to Day 1. Percent change from Baseline in hsCRP, non-parametric (Wilcoxon rank-sum test) analysis with Hodges-Lehmann estimates and confidence interval was performed. |
| Secondary | Absolute Change From Baseline in LDL-C at Week 12 and Week 24 | Baseline; Week 12; Week 24 | Change from Baseline is calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value ) x 100. Baseline is defined as the mean of the last two non-missing values on or prior to Day 1. |
Source ClinicalTrials.gov
Outcomes5
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 (PCFB) in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline; Week 12 | The Full Analysis Set (FAS), also known as the intention-to-treat (ITT) set of participants, is defined as all randomized participants. Participants were included in their randomized treatment group, regardless of the treatment they actually received. Only those participants with available data were analyzed. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in LDL-C at Week 24 | Baseline; Week 24 | FAS. Only those participants with available data were analyzed. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in the Lipid Profile at Week 12 | Baseline; Week 12 | FAS. Only those participants with available data were analyzed. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 12 | Baseline; Week 12 | FAS. Only those participants with available data were analyzed. | percent change | MEDIAN |
| SECONDARY | Absolute Change From Baseline in LDL-C at Week 12 and Week 24 | Baseline; Week 12; Week 24 | FAS. Only those participants with available data were analyzed. | mg/dL | MEAN |
Source ClinicalTrials.gov
Results by group16
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 (PCFB) in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 | Bempedoic Acid | -22.58 | Standard Error 1.290 | percent change | |
| Percent Change From Baseline (PCFB) in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 | Placebo | -1.17 | Standard Error 1.421 | percent change | |
| Percent Change From Baseline in LDL-C at Week 24 | Bempedoic Acid | -21.17 | Standard Error 1.411 | percent change | |
| Percent Change From Baseline in LDL-C at Week 24 | Placebo | -2.26 | Standard Error 1.552 | percent change | |
| Percent Change From Baseline in the Lipid Profile at Week 12 | Bempedoic Acid | non-HDL-C | -18.08 | Standard Error 1.114 | percent change |
| Percent Change From Baseline in the Lipid Profile at Week 12 | Placebo | non-HDL-C | -0.14 | Standard Error 1.169 | percent change |
| Percent Change From Baseline in the Lipid Profile at Week 12 | Bempedoic Acid | TC | -15.37 | Standard Error 0.879 | percent change |
| Percent Change From Baseline in the Lipid Profile at Week 12 | Placebo | TC | -0.61 | Standard Error 0.961 | percent change |
| Percent Change From Baseline in the Lipid Profile at Week 12 | Bempedoic Acid | apoB | -14.65 | Standard Error 1.080 | percent change |
| Percent Change From Baseline in the Lipid Profile at Week 12 | Placebo | apoB | 0.32 | Standard Error 1.177 | percent change |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bempedoic Acid | 234 | |
| Overall Study | STARTED | Placebo | 111 | |
| Overall Study | COMPLETED | Bempedoic Acid | 220 | |
| Overall Study | COMPLETED | Placebo | 107 | |
| Overall Study | NOT COMPLETED | Bempedoic Acid | 14 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
Source ClinicalTrials.gov
Adverse events82
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 | Dyspepsia | Gastrointestinal disorders | Bempedoic Acid | 5 | 234 | |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 0 | 111 | |
| other | Nausea | Gastrointestinal disorders | Bempedoic Acid | 4 | 234 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 3 | 111 | |
| other | Fatigue | General disorders | Bempedoic Acid | 8 | 234 | |
| other | Fatigue | General disorders | Placebo | 7 | 111 | |
| other | Bronchitis | Infections and infestations | Bempedoic Acid | 6 | 234 | |
| other | Bronchitis | Infections and infestations | Placebo | 6 | 111 | |
| other | Nasopharyngitis | Infections and infestations | Bempedoic Acid | 3 | 234 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 5 | 111 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bempedoic Acid | 0 | 234 |
| Total, all-cause mortality | Placebo | 0 | 111 |
| Total, other adverse events | Bempedoic Acid | 88 | 234 |
| Total, other adverse events | Placebo | 45 | 111 |
| Total, serious adverse events | Bempedoic Acid | 14 | 234 |
| Total, serious adverse events | Placebo | 4 | 111 |
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/NCT02988115
GET https://conductscience.org/api/trials/v1/NCT02988115/events?page=2