SOUL was a phase 3b trial carried out to evaluate the effect of Rybelsuson cardiovascular outcomes in people with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD).
Rybelsus is now the oral glucagon-like peptide 1 receptor agonist (GLP-1 RA) – mimicking a natural hormone in your body that helps regulate blood sugar, appetite, and digestion – available in the EU for type 2 diabetes with a proven cardiovascular benefit.
“Heart problems are the leading cause of disability and death for people living with type 2 diabetes. Therefore, treatments that also address heart problems are key to improving not only health outcomes, but also quality of life – and this approval will help do just that,” said Emil Kongshøj Larsen, executive vice president, International Operations at Novo Nordisk. “This milestone makes semaglutide the only oral GLP-1 RA with proven blood glucose and body weight reduction, as well as cardiovascular benefits.”
New results from the SOUL trial will be shared later this week at the European Association for the Study of Diabetes (EASD) 2025 Annual Meeting, 15–19 September. These include findings that treatment with oral semaglutide significantly reduced hospitalisations related to serious adverse events compared with placebo. Additional SOUL results will be presented at the same meeting, which highlight that the cardiovascular benefits of oral semaglutide were consistent regardless of body mass index (BMI) and body weight of participants.
In the US, a decision is expected later this year for a label extension for the cardiovascular indication for Rybelsus. Novo Nordisk has also submitted an application in the US for a once-daily 25 mg oral formulation of semaglutide (Wegovy in a pill) in adults living with obesity or overweight and cardiovascular disease. A decision is expected at the turn of this year, and if approved, Wegovy would become the oral GLP-1 RA indicated for chronic weight management.
Rybelsus is an oral GLP-1 RA approved for the treatment of type 2 diabetes, following its launch in 2019.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.