Clinical Trials

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

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.

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. 
 

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.  

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.
 

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.