Phase 3
Completed N=345
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant
Hypercholesterolemia · Cardiovascular Disease · Statin Adverse Reaction
Source: ClinicalTrials.gov NCT02988115 ↗
Enrolled (actual)
345
Serious AEs
5.2%
Results posted
Apr 2020
Primary outcomePrimary: Percent Change From Baseline (PCFB) in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 — -22.58; -1.17 percent change — p=<0.001
◆ Published Evidence
Highly cited
430citations · ~61 / year
Efficacy and Safety of Bempedoic Acid in Patients With Hypercholesterolemia and Statin Intolerance.
Summary
The purpose of this study is to determine if bempedoic acid (ETC-1002) is effective and safe versus placebo in patients with elevated LDL cholesterol and who are statin-intolerant.
Linked Publications (3)
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Efficacy and Safety of Bempedoic Acid in Patients With Hypercholesterolemia and Statin Intolerance.
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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 (PCFB) in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 |
-22.58; -1.17 | <0.001 sig |
| SECONDARY Percent Change From Baseline in LDL-C at Week 24 |
-21.17; -2.26 | <0.001 sig |
| SECONDARY Percent Change From Baseline in the Lipid Profile at Week 12 |
-18.08; -0.14; -15.37; -0.61; -14.65; 0.32 | <0.001 sig |
| SECONDARY Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 12 |
-25.37; 2.67 | <0.001 sig |
| SECONDARY Absolute Change From Baseline in LDL-C at Week 12 and Week 24 |
-39.3; -3.1; -37.0; -5.1 | — |
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)
- Be statin-intolerant (unable to tolerate 2 or more statins)
Exclusion Criteria
- Total fasting triglyceride ≥500 mg/dL
- Renal dysfunction or nephrotic syndrome or history of nephritis
- Body Mass Index (BMI) ≥50 kg/m2
- Significant cardiovascular disease or cardiovascular event in the past 3 months
Data sourced from ClinicalTrials.gov (NCT02988115) 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.