Phase 3
Completed N=382
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
Source: ClinicalTrials.gov NCT03337308 ↗Enrolled (actual)
382
Serious AEs
6.8%
Results posted
Apr 2020
Primary outcomePrimary: Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C) — -36.2; -17.2; -23.2; 1.8 Percent Change — p=<0.001
◆ Published Evidence
Highly cited
360citations · ~60 / year
Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy.
Summary
The purpose of this study is to determine if Bempedoic Acid (BA) + Ezetimibe (EZE) in a fixed-dose combination (FDC) is effective and safe versus its individual components and placebo in patients with elevated LDL cholesterol treated with maximally tolerated statin therapy.
Linked Publications
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Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C) |
-36.2; -17.2; -23.2; 1.8 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) |
-35.1; -31.9; -8.2; 21.6 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) |
-31.9; -14.1; -19.9; 1.8 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 12 in Total Cholesterol (TC) |
-26.4; -12.1; -16.0; 0.7 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B) |
-24.6; -11.8; -15.3; 5.5 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C) |
-5.59; -5.40; -2.11; -0.54 | — |
| SECONDARY Percent Change From Baseline to Week 12 in Triglycerides (TGs) |
-7.90; 7.94; -2.46; 5.47 | — |
Eligibility Criteria
Inclusion Criteria
- Require lipid-modifying therapy for primary or secondary prevention of cardiovascular disease
- Fasting LDL-C ≥ 130 mg/dL for primary prevention or LDL-C ≥ 100 mg/dL for secondary prevention (history of HeFH and/or ASCVD)
- Treated with maximally tolerated statin therapy at stable dose for at least 4 weeks prior to screening
Exclusion Criteria
- Total Fasting Triglyceride ≥ 400 mg/dL
- Renal Dysfunction or nephrotic syndrome or history of nephritis
- Significant cardiovascular disease or cardiovascular event within the past 3 months
Data sourced from ClinicalTrials.gov (NCT03337308) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.