Phase 3
Completed N=1,462
Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE)
Source: ClinicalTrials.gov NCT03067441 ↗Enrolled (actual)
1,462
Serious AEs
20.5%
Results posted
Dec 2020
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 385; 758; 1143; 97 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to see if bempedoic acid (ETC-1002) is safe and well-tolerated in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
385; 758; 1143; 97; 202; 299 | — |
| SECONDARY Percent Change From Parent Study Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Weeks 52 and 78 |
-12.82; -13.80; -13.47; -14.99; -14.15; -14.43 | — |
| SECONDARY Mean Change From Parent Study Baseline in LDL-C at Weeks 52 and 78 |
-14.08; -15.77; -15.19; -16.11; -16.04; -16.06 | — |
| SECONDARY Percent Change From Parent Study Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 52 and 78 |
-10.60; -10.55; -10.57; -12.50; -10.82; -11.38 | — |
| SECONDARY Percent Change From Parent Study Baseline in Total Cholesterol at Weeks 52 and 78 |
-9.01; -9.79; -9.53; -10.15; -9.34; -9.61 | — |
| SECONDARY Percent Change From Parent Study Baseline in Apolipoprotein B (ApoB) at Weeks 52 and 78 |
-7.5; -8.8; -8.4; -7.6; -7.0; -7.2 | — |
| SECONDARY Percent Change From Parent Study Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Weeks 52 and 78 |
-11.553; -19.709; -16.476; -15.005; -18.065; -16.740 | — |
| SECONDARY Percent Change From Parent Study Baseline in Triglycerides at Weeks 52 and 78 |
-4.31; -3.21; -3.49; -5.00; -2.60; -3.08 | — |
| SECONDARY Percent Change From Parent Study Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Weeks 52 and 78 |
-4.54; -7.06; -6.20; -3.42; -4.91; -4.41 | — |
| SECONDARY Percent Change From Open-Label Extension (OLE) Study Baseline in LDL-C at Weeks 52 and 78 |
-12.4; 3.6; -1.8; -14.3; 3.7; -2.3 | — |
| SECONDARY Mean Change From OLE Baseline in LDL-C at Weeks 52 and 78 |
-14.7; 0.6; -4.6; -17.0; 0.2; -5.5 | — |
| SECONDARY Percent Change From OLE Baseline in Non-HDL-C at Weeks 52 and 78 |
-10.0; 2.9; -1.4; -11.8; 3.1; -1.9 | — |
| SECONDARY Percent Change From OLE Baseline in Total Cholesterol at Weeks 52 and 78 |
-8.7; 1.3; -2.1; -9.7; 2.1; -1.8 | — |
| SECONDARY Percent Change From OLE Baseline ApoB at Weeks 52 and 78 |
-10.0; 0.2; -3.2; -10.2; 2.4; -1.8 | — |
| SECONDARY Percent Change From OLE Baseline in Hs-CRP at Weeks 52 and 78 |
-11.720; -2.174; -4.856; -14.953; 3.774; -2.538 | — |
| SECONDARY Percent Change From OLE Baseline in Triglycerides at Weeks 52 and 78 |
0.3; 0.9; 0.7; -2.0; 2.2; 0.9 | — |
| SECONDARY Percent Change From OLE Baseline in HDL-C at Weeks 52 and 78 |
-4.3; -0.6; -1.8; -3.4; 2.7; 0.7 | — |
Eligibility Criteria
Inclusion Criteria
- Successfully completed CLEAR Harmony (1002-040) parent study
Exclusion Criteria
- Experienced a treatment-related SAE that led to study drug discontinuation in the CLEAR Harmony (1002-040) parent study.
- Medical condition requires lipid measurement and/or adjustment of background lipid-regulating therapy.
Data sourced from ClinicalTrials.gov (NCT03067441). 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.