Esperion Therapeutics, Inc. announced participation in the TRANSFORM trial at the American Heart Association?s (AHA) 2023 Scientific Sessions. TRANSFORM is a randomized control trial ? sponsored by Cleerly ?

that aims to enroll 7,500 patients who have pre-diabetes, type 2 diabetes, or metabolic syndrome and have no symptoms of heart disease. TRANSFORM aims to prove that a personalized care strategy based on a Cleerly analysis of a patient?s actual disease state is better than traditional care based on typical risk factors for the primary prevention of cardiovascular events. TRANSFORM will enroll patients at 100-200 sites across the U.S. and treat atherosclerosis in patients with either no symptoms or a history of heart disease in order to reduce myocardial infarction (heart attacks).

The trial will utilize Cleerly?s investigational plaque staging system in the experimental arm to inform treatment and medication decisions made by providers. Participants will be randomly assigned to the personalized care strategy or to traditional care, and all participants will undergo a CCTA scan at baseline and at 24 months. Patients assigned to traditional care will be treated by their primary care providers using available treatment guidelines, and CCTA results will be provided at the end of the study.

Separately, those assigned to the personalized care strategy will have an investigational coronary artery disease (CAD) plaque staging system report for both baseline and at 24-months, and CCTA results will be provided to the central cardiologist-led team for discussion and care planning with the patient.