Esperion has one ongoing Phase 3 trial for bempedoic acid: In 2016, we initiated a global cardiovascular outcomes trial (CVOT) – CLEAR Outcomes – with nearly 14,000 patients in 32 countries. CLEAR Outcomes is the first CVOT that specifically enrolled patients with statin intolerance, and is an event-driven, randomized, multicenter, double-blind, placebo-controlled trial designed to evaluate the effect of bempedoic acid on four-component major adverse cardiovascular events (MACE).

As part of Esperion’s commitment to transparency, summaries of clinical studies are available below. Please visit clinicaltrials.gov for more information on clinical trials.

For additional information on CLEAR Outcomes, please visit esperionscience.com.

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Clinical Studies

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Bempedoic Acid

Phase 1
Phase 2
Phase 3

Evaluation of Major Cardiovascular Events in Patients With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo

Trial ID: NCT02993406

Key publication:
Nissen SE, et al. Bempedoic acid and cardiovascular outcomes in statin intolerant patients [published online ahead of print, March 4 2023]. NEngl J Med. DOI: 10.1056/NEJMoa2215024

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Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C.

Trial ID: NCT03001076

Key publication:
Ballantyne CM, Banach M, Mancini GBJ, et al. Efficacy and safety of bempedoic acid added to ezetimibe in statin-intolerant patients with hypercholesterolemia: A randomized, placebo-controlled study. Atherosclerosis. 2018;277:195-203.

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Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant.

Trial ID: NCT02988115

Key publication: Laufs U, Banach M, Mancini J, et al.  Efficacy and Safety of Bempedoic Acid in Patients With Hypercholesterolemia and Statin Intolerance.  Am Heart Assoc. 2019;8:e011662. 
 

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Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk.

Trial ID: NCT02988115

Key publication: Goldberg AC, Leiter LA, Stroes ESG, et al. 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. JAMA. 2019;322(18):1780–1788. doi:10.1001/jama.2019.16585.  

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Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk.

Trial ID: NCT02666664

Key publication: Ray KK, Bays HE, Catapano AL, et al.  Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol. N Engl J Med. 2019;380:1022-32.
 

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Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid.

Trial ID: NCT03067441

Key Publication: Ballantyne CM, Banach M, Bays HE, et al. Long-term safety and efficacy of bempedoic acid in patients at high risk of atherosclerotic cardiovascular disease: results from the CLEAR Harmony open-label extension. Poster presented at the 2020 European Society of Cardiology (ESC) Congress; virtual meeting. 

Additional publications based on Phase 3 studies
Banach M, Duell PB, Gotto AM Jr, et al. Association of Bempedoic Acid Administration With Atherogenic Lipid Levels in Phase 3 Randomized Clinical Trials of Patients With Hypercholesterolemia. JAMA Cardiol. 2020;e202314. 

Bays HE, Banach M, Catapano AL, et al. Bempedoic acid safety analysis: Pooled data from four phase 3 clinical trials. J Clin Lipidol. 2020;14(5):649-659.e6.

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Bempedoic Acid and Ezetimibe Fixed-Dose Combination

Phase 1
Phase 2
Phase 3

Trial ID: NCT03337308

Key publication:
Ballantyne CM, Laufs U, Ray KK, et al. Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy. Eur J Prev Cardiol. E Pub; July 29, 2019

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