Trial · NCT03337308
A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy
NCT03337308, Phase 3, Completed, Esperion Therapeutics, Inc.; results first posted 2020-04-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy. Trials, record NCT03337308. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03337308
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy
- NCT number
- NCT03337308
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 382 participants, actual
- Lead sponsor
- Esperion Therapeutics, Inc.
- Conditions
- Hyperlipidemias
- Interventions
- Bempedoic Acid + Ezetimibe Fixed-Dose Combination, Bempedoic Acid, Ezetimibe, Placebos
- First posted
- 2017-11-08
- Last updated
- 2020-04-08
- Results first posted
- 2020-04-08
- Limitations and caveats
- After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all data from these sites removed.
Source ClinicalTrials.gov
Registered outcomes7
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 | 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 Week -2 and predose Day 1/Week 0. Percent change from baseline in LDL-C was analyzed using analysis of covariance (ANCOVA) with treatment group and randomization stratification as a factors and baseline LDL-C as a covariate. Percent change from baseline was calculated as: (\[LDL-C value at Week 12 minus Baseline value\] divided by \[Baseline Value\]) multiplied by 100. For LDL-C, if measured LDL-C value was available, measured LDL-C was used. |
| Secondary | Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) | Baseline; Week 12 | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for hsCRP. Baseline was defined as the predose Day 1/Week 0 value. Percent change from baseline in hsCRP was analyzed using a non-parametric analysis. Percent change from baseline was calculated as: (\[hsCRP value at Week 12 minus Baseline value\] divided by \[Baseline Value\]) multiplied by 100. |
| Secondary | Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Baseline; Week 12 | 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 Week -2 and predose Day 1/Week 0. Percent change from baseline in non-HDL-C was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline non-HDL-C as a covariate. Percent change from baseline was calculated as: (\[non-HDL-C value at Week 12 minus Baseline value\] divided by \[Baseline Value\]) multiplied by 100. |
| Secondary | Percent Change From Baseline to Week 12 in Total Cholesterol (TC) | Baseline; Week 12 | 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 Week -2 and predose Day 1/Week 0. Percent change from baseline in TC was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline TC as a covariate. Percent change from baseline was calculated as: (\[TC value at Week 12 minus Baseline value\] divided by \[Baseline Value\]) multiplied by 100. |
| Secondary | Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B) | Baseline; Week 12 | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for apo B. Baseline was defined as the predose Day 1/Week 0 value. Percent change from baseline in apo B was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline apo B as a covariate. Percent change from baseline was calculated as: (\[apo B value at Week 12 minus Baseline value\] divided by \[Baseline Value\]) multiplied by 100. |
| Secondary | Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C) | Baseline; Week 12 | 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 Week -2 and predose Day 1/Week 0. Percent change from baseline was calculated as: (\[HDL-C value at Week 12 minus Baseline value\] divided by \[Baseline Value\]) multiplied by 100. |
| Secondary | Percent Change From Baseline to Week 12 in Triglycerides (TGs) | Baseline; Week 12 | 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 Week -2 and predose Day 1/Week 0. Percent change from baseline was calculated as: (\[TGs value at Week 12 minus Baseline value\] divided by \[Baseline Value\]) multiplied by 100. |
Source ClinicalTrials.gov
Outcomes7
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 (FAS), also known as the intention-to-treat set, was defined as all randomized participants. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed. | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) | Baseline; Week 12 | FAS. Only participants with available data were analyzed. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice;therefore, analysis was completed with all efficacy data from these sites removed. | Percent Change | MEDIAN |
| SECONDARY | Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Baseline; Week 12 | FAS. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 12 in Total Cholesterol (TC) | Baseline; Week 12 | FAS. Only participants with available data were analyzed. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B) | Baseline; Week 12 | FAS. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed. Only participants with available data were analyzed. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C) | Baseline; Week 12 | FAS. Only participants with available data were analyzed. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline to Week 12 in Triglycerides (TGs) | Baseline; Week 12 | FAS. Only participants with available data were analyzed. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed. | Percent change | MEAN |
Source ClinicalTrials.gov
Results by group28
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) | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | -36.2 | Standard Error 2.56 | Percent Change | |
| Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C) | Bempedoic Acid 180 mg | -17.2 | Standard Error 2.52 | Percent Change | |
| Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C) | Ezetimibe 10 mg | -23.2 | Standard Error 2.18 | Percent Change | |
| Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C) | Placebo | 1.8 | Standard Error 3.49 | Percent Change | |
| Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | -35.1 | Inter-Quartile Range -56.5 to -2.3 | Percent Change | |
| Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) | Bempedoic Acid 180 mg | -31.9 | Inter-Quartile Range -62.6 to 7.7 | Percent Change | |
| Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) | Ezetimibe 10 mg | -8.2 | Inter-Quartile Range -34.4 to 32.0 | Percent Change | |
| Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) | Placebo | 21.6 | Inter-Quartile Range -18.5 to 68.5 | Percent Change | |
| Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | -31.9 | Standard Error 2.23 | Percent change | |
| Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Bempedoic Acid 180 mg | -14.1 | Standard Error 2.17 | Percent change |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | 108 | |
| Overall Study | STARTED | Bempedoic Acid 180 mg | 110 | |
| Overall Study | STARTED | Ezetimibe 10 mg | 109 | |
| Overall Study | STARTED | Placebo | 55 | |
| Overall Study | COMPLETED | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | 103 | |
| Overall Study | COMPLETED | Bempedoic Acid 180 mg | 103 | |
| Overall Study | COMPLETED | Ezetimibe 10 mg | 104 | |
| Overall Study | COMPLETED | Placebo | 53 | |
| Overall Study | NOT COMPLETED | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | 5 | |
| Overall Study | NOT COMPLETED | Bempedoic Acid 180 mg | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events132
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 | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | 1 | 107 | |
| other | Anaemia | Blood and lymphatic system disorders | Bempedoic Acid 180 mg | 2 | 110 | |
| other | Anaemia | Blood and lymphatic system disorders | Ezetimibe 10 mg | 1 | 109 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 2 | 55 | |
| other | Constipation | Gastrointestinal disorders | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | 4 | 107 | |
| other | Constipation | Gastrointestinal disorders | Bempedoic Acid 180 mg | 0 | 110 | |
| other | Constipation | Gastrointestinal disorders | Ezetimibe 10 mg | 2 | 109 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 0 | 55 | |
| other | Nasopharyngitis | Infections and infestations | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | 4 | 107 | |
| other | Nasopharyngitis | Infections and infestations | Bempedoic Acid 180 mg | 6 | 110 |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | 0 | 107 |
| Total, all-cause mortality | Bempedoic Acid 180 mg | 0 | 110 |
| Total, all-cause mortality | Ezetimibe 10 mg | 0 | 109 |
| Total, all-cause mortality | Placebo | 0 | 55 |
| Total, other adverse events | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | 26 | 107 |
| Total, other adverse events | Bempedoic Acid 180 mg | 27 | 110 |
| Total, other adverse events | Ezetimibe 10 mg | 26 | 109 |
| Total, other adverse events | Placebo | 12 | 55 |
| Total, serious adverse events | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | 8 | 107 |
| Total, serious adverse events | Bempedoic Acid 180 mg | 7 | 110 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers6
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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Read this trial from software.
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