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Clinical trials
catalyst calendar across sponsors →Studies where ESPR is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
23 interventional · 1 observational · 15 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Bempedoic Acid Pregnancy Surveillance ProgramNCT05103254observationalMajor congenital malformations (MCM) | — | Recruiting | Drug: Bempedoic Acid, Bempedoic Acid / Ezetimibe | Pregnancy, Hyperlipidemias | 20 | May 2032 | ≤ 2,112 d | 2024-05-17 |
| A Clinical Study in Children With Heterozygous Familial Hypercholesterolemia (HeFH) Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing (CLEAR Path 1)NCT05694260results2026-07-17Observed Trough Plasma Concentration of ETC-1002 Following 8 Weeks of Steady State Dosing of Bempedoic AcidNon-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Bempedoic acid | Hypercholesterolemia | 31 | 2025-06-04actual | — | 2026-07-17 |
| Milk-Only Lactation Study to Evaluate the Concentration of Bempedoic Acid and Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP) in the Breast Milk of Healthy Lactating WomenNCT06021951results2025-04-11Daily Infant DoseRandomized · Open-label · Basic scienceStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: Bempedoic Acid 180 MG Oral Tablet, Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet | Healthy Lactating Women | 16 | 2024-02-21actual | — | 2025-04-11 |
| Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or PlaceboNCT02993406results2024-01-03Number of Participants With First Occurrence of Four Component Major Adverse Cardiovascular Events (MACE)Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Bempedoic acid 180 mg tablet, Matching placebo tablet | Cardiovascular Diseases, Statin Adverse Reaction | 13,970 | 2022-11-07actual | — | 2024-01-03 |
| Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE)NCT03067441results2020-12-22Number of Participants With Treatment-Emergent Adverse Events (TEAEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: bempedoic acid | Hypercholesterolemia, Atherosclerotic Cardiovascular Disease | 1,462 | 2019-11-05actual | — | 2021-03-01 |
| Bempedoic Acid + Ezetimibe Fixed-Dose Combination (FDC) Study in Patients With Type 2 Diabetes and Elevated LDL-CNCT03531905results2020-04-09Percent Change From Baseline to Week 12/End of Study (EOS) in Low-density Lipoprotein Cholesterol (LDL-C)Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Bempedoic acid + Ezetimibe FDC Oral Tablet, Ezetimibe 10 mg Oral Tablet, Placebo Oral Tablet, Placebo oral capsule | Diabetes, Diabetes Mellitus, Type 2, Cholesterolemia | 242 | 2019-06-18actual | — | 2020-04-09 |
| Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular RiskNCT02991118results2020-04-27Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: bempedoic acid, placebo | Hypercholesterolemia, Atherosclerotic Cardiovascular Disease | 779 | 2018-08-22actual | — | 2020-04-27 |
| 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 TherapyNCT03337308results2020-04-08Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Combination product: Bempedoic Acid + Ezetimibe Fixed-Dose Combination · Drug: Bempedoic Acid, Ezetimibe, Placebos | Hyperlipidemias | 382 | 2018-06-18actual | — | 2020-04-08 |
| Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin IntolerantNCT02988115results2020-04-03Percent Change From Baseline (PCFB) in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: bempedoic acid · Other: placebo | Hypercholesterolemia, Atherosclerotic Cardiovascular Disease, Statin Adverse Reaction | 345 | 2018-03-16actual | — | 2020-04-03 |
| Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony)NCT02666664results2020-04-20Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)Randomized · Triple-masked · TreatmentStatistical Analysis Plan ↗ · Study Protocol ↗ | Phase 3 | Completed | Drug: ETC-1002, Placebo | Hypercholesterolemia, Atherosclerotic Cardiovascular Diseases | 2,230 | 2018-02-21actual | — | 2020-05-11 |
| Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg When Added to PCSK9 Inhibitor TherapyNCT03193047results2020-04-03Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Month 2Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: bempedoic acid 180mg, evolocumab · Other: placebo | Hypercholesterolemia | 59 | 2018-01-29actual | — | 2020-04-03 |
| Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility)NCT03001076results2020-04-03Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C)Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Bempedoic acid, Ezetimibe · Other: Placebo | Hypercholesterolemia, Atherosclerosis, Statin Adverse Reaction | 269 | 2018-01-11actual | — | 2020-05-11 |
| Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg, Ezetimibe 10mg, and Atorvastatin 20 mg Triplet Therapy in Patients With Elevated LDL-CNCT03051100results2020-04-03Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 6Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Bempedoic acid 180mg, Ezetimibe 10mg, Atorvastatin 20mg · Other: Placebo | Hypercholesterolemia | 63 | 2017-06-01actual | — | 2020-04-03 |
| A Study Of Pharmacokinetics, Pharmacodynamics And Safety Of Adding ETC-1002 To Atorvastatin 80 mgNCT02659397Peak plasma concentration (Cmax) pharmacokinetics of atorvastatin and its active metabolitesRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ETC-1002, Atorvastatin, Placebo | Hyperlipidemia | 68 | Jul 2016actual | — | 2019-03-29 |
| Evaluation of ETC-1002 in Participants With Hypercholesterolemia and HypertensionNCT02178098results2023-04-04Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) to Week 6Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ETC-1002, Placebo | Hypercholesterolemia, Hypertension | 143 | 2015-05-22actual | — | 2023-04-04 |
| Evaluation of ETC-1002 vs Placebo in Patients Receiving Ongoing Statin TherapyNCT02072161Percent change from baseline in calculated low density lipoprotein-cholesterol (LDL-C)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ETC-1002, Placebo, Statin Therapy | Hypercholesterolemia | 133 | Jan 2015actual | — | 2019-03-29 |
| Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic PatientsNCT01941836Percent change in calculated low density lipoprotein-cholesterol (LDL-C)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ETC-1002, Ezetimibe | Hypercholesterolemia | 349 | Oct 2014actual | — | 2019-03-29 |
| Single Radiolabeled Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-ETC-1002NCT02044627Level of [14C]-ETC-1002 in urine and feces after a single doseOpen-label · Diagnostic | Phase 1 | Completed | Drug: [14C-ETC-1002] | Hyperlipidemia | 6 | Jan 2014actual | — | 2019-02-15 |
| A Study of the Safety, Pharmacokinetic Drug Interaction and Efficacy of ETC-1002 and Atorvastatin in Subjects With HypercholesterolemiaNCT01779453Area under the plasma concentration versus time curve (AUC) of atorvastatin and its active metabolitesRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ETC-1002, Placebo, Atorvastatin | Hypercholesterolemia | 58 | Aug 2013actual | — | 2019-03-29 |
| A Study of the Efficacy and Safety of ETC-1002 in Participants With Statin IntoleranceNCT01751984results2022-04-04Percent Change From Baseline to Week 8 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ETC-1002, Placebo | Hypercholesterolemia | 56 | 2013-05-01actual | — | 2022-04-04 |
| A Single Center Study to Evaluate the Efficacy and Safety of ETC 1002 in Subjects With Type 2 DiabetesNCT01607294assess the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetesRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ETC-1002, Placebo | Hyperlipidemia, Type 2 Diabetes | 60 | Oct 2012actual | — | 2019-03-29 |
| A Multiple Ascending Dose Study of ETC-1002 in Healthy SubjectsNCT01485146Measuring subject safety by collecting and evaluating vital signs, adverse events, and laboratory measures.Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: ETC-1002 | Safety Evaluation of Escalating Doses | 24 | 2012-01-25actual | — | 2019-03-28 |
| A Study to Assess the Efficacy and Safety of ETC-1002 in Subjects With Elevated Blood Cholesterol and Either Normal or Elevated TriglyceridesNCT01262638results2021-03-16Percent Change From Baseline to Week 12 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: ETC-1002, Placebo | Dyslipidemia | 177 | 2011-08-23actual | — | 2021-03-17 |
| A Multiple Ascending Dose Study of ETC-1002 in Subjects With Mild DyslipidemiaNCT01105598Assessment of safety and tolerability using adverse event reports, physical exams, vitals signs, ECGs, and clinical lab valuesRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: ETC-1002 or placebo, ETC-1002 or placebo, ETC-1002 or placebo | Mild Dyslipidemia | 53 | 2010-10-02actual | — | 2019-03-28 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19