Trial · NCT03531905
Bempedoic Acid + Ezetimibe Fixed-Dose Combination (FDC) Study in Patients With Type 2 Diabetes and Elevated LDL-C
NCT03531905, Phase 2, Completed, Esperion Therapeutics, Inc.; results first posted 2020-04-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bempedoic Acid + Ezetimibe Fixed-Dose Combination (FDC) Study in Patients With Type 2 Diabetes and Elevated LDL-C. Trials, record NCT03531905. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03531905
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bempedoic Acid + Ezetimibe Fixed-Dose Combination (FDC) Study in Patients With Type 2 Diabetes and Elevated LDL-C
- NCT number
- NCT03531905
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 242 participants, actual
- Lead sponsor
- Esperion Therapeutics, Inc.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Cholesterolemia
- Interventions
- Bempedoic acid + Ezetimibe FDC Oral Tablet, Ezetimibe 10 mg Oral Tablet, Placebo Oral Tablet, Placebo oral capsule
- First posted
- 2018-05-22
- Last updated
- 2020-04-09
- Results first posted
- 2020-04-09
- Limitations and caveats
Sites 5801003, 5801041, and 5801043 were suspected of Good Clinical Practice violations in an earlier Phase 3 trial (NCT03337308), hence the Efficacy Analysis Set (which excluded these 3 sites) was designated as the primary efficacy analysis set.
Source ClinicalTrials.gov
Registered outcomes16
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/End of Study (EOS) in Low-density Lipoprotein Cholesterol (LDL-C) | Baseline; Week 12 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the average of LDL-C values at the Screening Visit 3 (Visit S3) and the Treatment Visit 1 (Visit T1) (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for LDL-C was analyzed using analysis of covariance (ANCOVA), with treatment as factor and Baseline lipid parameter as a covariate. Missing data for LDL-C was imputed using the last observation carried forward (LOCF) method. 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 a measured LDL-C value was available, measured LDL-C was used. |
| Secondary | Percent Change From Baseline to Week 12/EOS in LDL-C (Comparing Ezetimibe With Placebo) | Baseline; Week 12 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the average of LDL-C values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for LDL-C was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for LDL-C was imputed using the LOCF method. 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 a 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 at pre-specified intervals. Samples were collected and analyzed for hsCRP. Baseline was defined as the last value prior to the first dose of investigational medicinal product (IMP). Percent change from Baseline for hsCRP was analyzed using a non-parametric approach. Percent change from Baseline was calculated as: (\[hsCRP value at Week 12 minus Baseline value\] divided by \[Baseline value\]) multiplied by 100. For hsCRP, if a measured hsCRP value was available, measured hsCRP was used. |
| 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 at pre-specified intervals. Samples were collected and analyzed for non-HDL-C. Baseline was defined as the average of non-HDL-C values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for non-HDL-C was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for non-HDL-C was imputed using the LOCF method. Percent change from Baseline was calculated as: (\[non-HDL-C value at Week 12 minus Baseline value\] divided by \[Baseline value\]) multiplied by 100. For non-HDL-C, if a measured non-HDL-C value was available, measured non-HDL-C was used. |
| 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 at pre-specified intervals. Samples were collected and analyzed for TC. Baseline was defined as the average of TC values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for TC was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for TC was imputed using the LOCF method. Percent change from Baseline was calculated as: (\[TC value at Week 12 minus Baseline value\] divided by \[Baseline value\]) multiplied by 100. For TC, if a measured TC value was available, measured TC was used. |
| 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 at pre-specified intervals. Samples were collected and analyzed for apo B. Baseline was defined as the last value prior to the first dose of IMP. Percent change from Baseline for TC was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for apo B was imputed using the LOCF method. Percent change from Baseline was calculated as: (\[apo B value at Week 12 minus Baseline value\] divided by \[Baseline value\]) multiplied by 100. For apo B, if a measured apo B value was available, measured apo B was used. |
| Secondary | Percent Change From Baseline to Week 12 in Triglycerides (TGs) | Baseline; Week 12 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for TGs. Baseline was defined as the average of TG values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for TGs was analyzed using a non-parametric approach. Percent change from Baseline was calculated as: (\[TG value at Week 12 minus Baseline value\] divided by \[Baseline value\]) multiplied by 100. For TGs, if a measured TG value was available, measured TG was used. |
| 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 at pre-specified intervals. Samples were collected and analyzed for HDL-C. Baseline was defined as the average of HDL-C values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for HDL-C was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for HDL-C was imputed using the LOCF method. Percent change from Baseline was calculated as: (\[HDL-C value at Week 12 minus Baseline value\] divided by \[Baseline value\]) multiplied by 100. For HDL-C, if a measured HDL-C value was available, measured HDL-C was used. |
| Secondary | Number of Participants With LDL-C <70 Milligrams Per Deciliter (mg/dL) at Week 12 | Week 12 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for LDL-C. For LDL-C, if a measured LDL-C value was available, measured LDL-C was used. |
| Secondary | Secondary Outcome Measure: Number of Participants With an LDL-C Reduction of ≥50% From Baseline at Week 12 | Baseline; Week 12 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the average of LDL-C values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. LDL-C reduction from Baseline was calculated as the LDL-C value at Week 12 minus the Baseline value. For LDL-C, if a measured LDL-C value was available, measured LDL-C was used. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
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/End of Study (EOS) in Low-density Lipoprotein Cholesterol (LDL-C) | Baseline; Week 12 | Efficacy Analysis Set (EAS): all randomized participants who received at least one dose of investigational medicinal product (Full Analysis Set), excluding participants at three study sites. Only participants with available data were analyzed. | Percent change | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 12/EOS in LDL-C (Comparing Ezetimibe With Placebo) | Baseline; Week 12 | EAS. Only participants with available data were analyzed. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) | Baseline; Week 12 | EAS. Only participants with available data were analyzed. | Percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Baseline; Week 12 | EAS. Only participants with available data were analyzed. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 12 in Total Cholesterol (TC) | Baseline; Week 12 | EAS. Only participants with available data were analyzed. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B) | Baseline; Week 12 | EAS. Only participants with available data were analyzed. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 12 in Triglycerides (TGs) | Baseline; Week 12 | EAS. Only participants with available data were analyzed. | Percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C) | Baseline; Week 12 | EAS. Only participants with available data were analyzed. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With LDL-C <70 Milligrams Per Deciliter (mg/dL) at Week 12 | Week 12 | EAS. Only participants with available data were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Secondary Outcome Measure: Number of Participants With an LDL-C Reduction of ≥50% From Baseline at Week 12 | Baseline; Week 12 | EAS. Only participants with available data were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group47
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/End of Study (EOS) in Low-density Lipoprotein Cholesterol (LDL-C) | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | -38.8 | Standard Error 2.24 | Percent change | |
| Percent Change From Baseline to Week 12/End of Study (EOS) in Low-density Lipoprotein Cholesterol (LDL-C) | Ezetimibe 10 mg | -19.2 | Standard Error 2.16 | Percent change | |
| Percent Change From Baseline to Week 12/End of Study (EOS) in Low-density Lipoprotein Cholesterol (LDL-C) | Placebo | 0.9 | Standard Error 2.20 | Percent change | |
| Percent Change From Baseline to Week 12/EOS in LDL-C (Comparing Ezetimibe With Placebo) | Ezetimibe 10 mg | -19.2 | Standard Error 2.16 | Percent change | |
| Percent Change From Baseline to Week 12/EOS in LDL-C (Comparing Ezetimibe With Placebo) | Placebo | 0.9 | Standard Error 2.20 | Percent change | |
| Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | -25.347 | Inter-Quartile Range -48.980 to 3.292 | Percent change | |
| Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) | Ezetimibe 10 mg | 2.078 | Inter-Quartile Range -22.610 to 48.770 | Percent change | |
| Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) | Placebo | 14.085 | Inter-Quartile Range -21.642 to 50.776 | 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 | -33.0 | Standard Error 2.01 | Percent change | |
| Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Ezetimibe 10 mg | -17.8 | Standard Error 1.94 | Percent change |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 results by groupParticipant flow9
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 | 81 | |
| Overall Study | STARTED | Ezetimibe 10 mg | 81 | |
| Overall Study | STARTED | Placebo | 80 | |
| Overall Study | COMPLETED | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | 74 | |
| Overall Study | COMPLETED | Ezetimibe 10 mg | 76 | |
| Overall Study | COMPLETED | Placebo | 77 | |
| Overall Study | NOT COMPLETED | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | 7 | |
| Overall Study | NOT COMPLETED | Ezetimibe 10 mg | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events18
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 | Bronchitis | Infections and infestations | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | 0 | 81 | |
| other | Bronchitis | Infections and infestations | Ezetimibe 10 mg | 3 | 81 | |
| other | Bronchitis | Infections and infestations | Placebo | 0 | 80 | |
| other | Urinary tract infection | Infections and infestations | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | 3 | 81 | |
| other | Urinary tract infection | Infections and infestations | Ezetimibe 10 mg | 3 | 81 | |
| other | Urinary tract infection | Infections and infestations | Placebo | 3 | 80 | |
| other | Blood glucose increased | Investigations | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | 3 | 81 | |
| other | Blood glucose increased | Investigations | Ezetimibe 10 mg | 0 | 81 | |
| other | Blood glucose increased | Investigations | Placebo | 0 | 80 | |
| other | Glycosylated haemoglobin increased | Investigations | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | 2 | 81 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals9
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 | 81 |
| Total, all-cause mortality | Ezetimibe 10 mg | 0 | 81 |
| Total, all-cause mortality | Placebo | 0 | 80 |
| Total, other adverse events | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | 8 | 81 |
| Total, other adverse events | Ezetimibe 10 mg | 6 | 81 |
| Total, other adverse events | Placebo | 7 | 80 |
| Total, serious adverse events | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | 0 | 81 |
| Total, serious adverse events | Ezetimibe 10 mg | 1 | 81 |
| Total, serious adverse events | Placebo | 1 | 80 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24385236 | BACKGROUND |
Source PubMed
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.
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/NCT03531905
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