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CHICAGO, IL – A new pill form of the popular diabetes and weight-management drug semaglutide has shown significant promise in protecting high-risk individuals with type 2 diabetes from major cardiovascular events, according to findings from a large international clinical trial.
The study, known as the Semaglutide cardiOvascular oUtcomes triaL (SOUL), found that daily oral semaglutide reduced the risk of events like heart attacks and strokes by 14% compared to a placebo in patients already diagnosed with cardiovascular or chronic kidney disease.
Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, has gained widespread attention in its injectable form for effectively managing blood sugar, promoting weight loss, and even potentially curbing alcohol cravings. This new research, co-led by Dr. John Buse and Dr. Matthew Cavender at the UNC School of Medicine, focused specifically on the cardiovascular impact of its oral formulation.
“Heart attacks and strokes are among the most common and devastating complications of diabetes,” stated Dr. Buse, Director of the UNC Diabetes Care Center. “Semaglutide has been a main stay of our efforts to reduce heart attack and stroke in people with diabetes. Having an oral option to deliver this highly effective therapy is a big advance.”
Type 2 diabetes significantly increases the risk of cardiovascular disease, often leading to complications like high blood pressure and high cholesterol due to difficulties in controlling blood sugar levels. While GLP-1 agonists are known to lower blood sugar, definitive evidence on the cardiovascular benefits of oral semaglutide was previously lacking.
The SOUL trial, sponsored by pharmaceutical company Novo Nordisk, Inc., enrolled 9,650 participants with type 2 diabetes who also had established atherosclerotic cardiovascular disease (such as coronary artery disease, peripheral arterial disease, or cerebrovascular disease) or chronic kidney disease. Participants were randomly assigned to receive either a daily 14mg dose of oral semaglutide or a placebo, in addition to standard diabetes and cardiovascular care based on local guidelines.
Researchers observed a notable 14% decrease in the occurrence of major adverse cardiovascular events in the group taking oral semaglutide. The most significant risk reduction was seen specifically for nonfatal myocardial infarction (heart attacks). These positive effects were consistent across different ages and genders within the study population.
The results align with findings from previous trials involving injectable semaglutide, though the study authors note that further research is necessary to directly compare the cardiovascular efficacy of the oral versus injectable forms.
The trial’s findings were published in the New England Journal of Medicine on March 28, 2025, and presented at the American College of Cardiology’s Annual Scientific Session & Expo in Chicago. This development offers a potentially more convenient treatment avenue for reducing cardiovascular risk in a vulnerable patient population.
Disclaimer: This news article is based on information provided regarding the SOUL clinical trial, sponsored by Novo Nordisk, Inc., and published in the New England Journal of Medicine. It is intended for informational purposes only and does not constitute medical advice. Consult with a qualified healthcare professional for any health concerns or before making any decisions related to your treatment.
