Phase 3
Completed N=779
Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk
Source: ClinicalTrials.gov NCT02991118 ↗Enrolled (actual)
779
Serious AEs
19.8%
Results posted
Apr 2020
Primary outcomePrimary: Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C) — 2.35; -15.07 percent change — p=<0.001
◆ Published Evidence
Highly cited
476citations · ~68 / year
Effect of Bempedoic Acid vs Placebo Added to Maximally Tolerated Statins on Low-Density Lipoprotein Cholesterol in Patients at High Risk for Cardiovascular Disease: The CLEAR Wisdom Randomized Clinical Trial.
Summary
The purpose of this study is to see if bemedoic acid (ETC-1002) is effective versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol not adequately controlled by their current therapy.
Linked Publications (3)
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Effect of Bempedoic Acid vs Placebo Added to Maximally Tolerated Statins on Low-Density Lipoprotein Cholesterol in Patients at High Risk for Cardiovascular Disease: The CLEAR Wisdom Randomized Clinical Trial.
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Association of Bempedoic Acid Administration With Atherogenic Lipid Levels in Phase 3 Randomized Clinical Trials of Patients With Hypercholesterolemia.
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Factors Associated With Enhanced Low-Density Lipoprotein Cholesterol Lowering With Bempedoic Acid.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C) |
2.35; -15.07 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 24 in LDL-C |
2.66; -12.10 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) |
2.28; -10.75 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 12 in Total Cholesterol (TC) |
1.26; -9.94 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 12 in Apolipoprotein b (Apo B) |
3.73; -9.29 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) |
-9.366; -18.699 | <0.039 sig |
| SECONDARY Change From Baseline to Week 12 in LDL-C |
0.0; -21.2 | — |
| SECONDARY Change From Baseline to Week 24 in LDL-C |
-1.0; -18.7 | — |
Eligibility Criteria
Inclusion Criteria
- Fasting LDL-C ≥100 mg/dL
- High cardiovascular risk (diagnosis of HeFH and/or ASCVD)
- Be on maximally tolerated lipid-modifying therapy (LMT), including maximally tolerated statin either alone or in combination with other LMTs
Exclusion Criteria
- Total fasting triglyceride ≥500 mg/dL
- Renal dysfunction or nephrotic syndrome or history of nephritis
- Body Mass Index (BMI) ≥50kg/m2
- Significant cardiovascular disease or cardiovascular event in the past 3 months
Data sourced from ClinicalTrials.gov (NCT02991118) 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.