Effects of oral semaglutide on cardiovascular outcomes in individuals with type 2 diabetes and established atherosclerotic cardiovascular disease and/or chronic kidney disease: SOUL, a randomized trial, design and baseline characteristics

The article describes the design and baseline clinical data of the Semaglutide cardiOvascular oUtcomes triaL (SOUL), which aims to assess the effects of oral semaglutide on the risk of cardiovascular events in individuals with type 2 diabetes and established atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). The trial is a randomized, double‐blind, placebo-controlled trial with 9650 participants aged ≥50 years. The primary outcome is time from randomization to first occurrence of a major adverse cardiovascular event (MACE). Enrollment has been completed, and the trial will continue until 1225 first adjudication-confirmed MACEs have occurred. The article provides baseline clinical data on the participants, including their age, duration of diabetes, body mass index, and prevalent comorbidities such as CAD, CKD, cerebrovascular disease, and symptomatic PAD. The trial will provide evidence regarding the cardiovascular effects of oral semaglutide in individuals with type 2 diabetes and established ASCVD and/or CKD.