The SOUL trial provided important new evidence on the cardiovascular effects of semaglutide. Here is what it studied, what it found, and how to interpret it.
What the SOUL trial studied
SOUL was a phase 3b, randomized, double-blind, placebo-controlled trial of 9,650 adults aged 50 or older with type 2 diabetes and established atherosclerotic cardiovascular disease, chronic kidney disease, or both. Participants received once-daily oral semaglutide (up to 14 mg) or placebo in addition to their standard care, and were followed for a median of about four years.[1]
Key findings
- 14% fewer major cardiovascular events. Semaglutide reduced the combined rate of heart attack, stroke, and cardiovascular death by 14% versus placebo.
- 26% fewer non-fatal heart attacks, the largest single contributor to the overall benefit.
- 12% fewer non-fatal strokes.
- 7% lower cardiovascular death.
These benefits came without a significant increase in serious adverse events.[1]
What it means, and what it does not
SOUL adds to the evidence that semaglutide can reduce cardiovascular risk in a specific high-risk group: people with type 2 diabetes who already have heart or kidney disease. It studied the oral 14 mg formulation, and the results apply to that population. They should not be read as a promise of heart benefit for everyone taking semaglutide, and they are separate from semaglutide's use for weight loss. Your own cardiovascular risk, and whether semaglutide is appropriate, are questions for your clinician.
Talking to a clinician
If you have questions about semaglutide and your heart health, discuss them with a licensed clinician who knows your history. At IVUSE+, compounded semaglutide is prescribed and managed through async telehealth, and every plan starts with a clinical review. You can also read our overview of how GLP-1 medications work.
References
- McGuire DK, Marx N, Mulvagh SL, et al. Oral Semaglutide and Cardiovascular Outcomes in High-Risk Type 2 Diabetes (SOUL). New England Journal of Medicine. 2025. doi:10.1056/NEJMoa2501006.
This article is for general education and is not medical advice. Compounded medications are not FDA-approved. Talk with a licensed clinician about your cardiovascular risk and treatment options.
