Phase 3
Completed N=2,230
Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony)
Hypercholesterolemia · Atherosclerotic Cardiovascular Diseases
Source: ClinicalTrials.gov NCT02666664 ↗
Enrolled (actual)
2,230
Serious AEs
14.4%
Results posted
Apr 2020
Primary outcomePrimary: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) — 78.7; 78.5; 14.0; 14.5 percentage of participants
◆ Published Evidence
Highly cited
792citations · ~113 / year
Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol.
Summary
The purpose of this study is to see if ETC-1002 (bempedoic acid) is safe and well-tolerated versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy.
Linked Publications (4)
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Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol.
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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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Effects of bempedoic acid on CRP, IL-6, fibrinogen and lipoprotein(a) in patients with residual inflammatory risk: A secondary analysis of the CLEAR harmony trial.
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Factors Associated With Enhanced Low-Density Lipoprotein Cholesterol Lowering With Bempedoic Acid.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) |
78.7; 78.5; 14.0; 14.5; 0.3; 0.9 | — |
| PRIMARY Percentage of Participants With Adjudicated Major Adverse Cardiovascular Event |
5.7; 4.6; 0.1; 0.4; 1.8; 1.3 | — |
| PRIMARY Percentage of Participants With the Indicated Event of Special Interest: Creatine Kinase Elevations |
1.8; 2.4 | — |
| PRIMARY Percentage of Participants With the Indicated Event of Special Interest: Hepatic Disorders |
1.5; 2.5; 0.4; 1.5; 0.3; 0.8 | — |
| PRIMARY Percentage of Participants With the Indicated Event of Special Interest: Hypoglycemia |
3.1; 2.2; 3.0; 2.2; 0.1; 0.1 | — |
| PRIMARY Percentage of Participants With the Indicated Event of Special Interest: Metabolic Acidosis |
0.0; 0.1 | — |
| PRIMARY Percentage of Participants With the Indicated Event of Special Interest: Muscular Disorder |
10.1; 13.1; 6.1; 6.0; 2.7; 4.2 | — |
| PRIMARY Percentage of Participants With the Indicated Event of Special Interest: Neurocognitive Disorder |
0.9; 0.7; 0.5; 0.3; 0.4; 0.2 | — |
| PRIMARY Percentage of Participants With the Indicated Event of Special Interest: New Onset or Worsening Diabetes Mellitus |
5.4; 3.3; 0.9; 1.0; 0.9; 0.4 | — |
| PRIMARY Percentage of Participants With the Indicated Event of Special Interest: Renal Disorder |
0.1; 0.9; 0.1; 0.4; 0.3; 0.3 | — |
| PRIMARY Change From Baseline to Week 52 in Uric Acid (Urate) Level |
5.96; 6.06; -0.06; 0.73 | — |
| PRIMARY Change From Baseline to Week 52 in Creatinine Level |
0.96; 0.97; -0.02; 0.02 | — |
| PRIMARY Change From Baseline to Week 52 in Hemoglobin Level |
14.07; 14.22; -0.23; -0.58 | — |
| SECONDARY Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C) |
1.6; -16.5 | <0.001 sig |
| SECONDARY Absolute Change From Baseline to Week 12 in LDL-C |
0.43; -19.23 | — |
Eligibility Criteria
Inclusion Criteria
- Fasting LDL-C ≥ 70 mg/dL
- High cardiovascular risk (diagnosis of HeFH or ASCVD)
- Be on maximally tolerated lipid-modifying therapy
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 (NCT02666664) 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.