Novo Nordisk’s Rybelsus®: A Game-Changer in Type 2 Diabetes and Cardiovascular Health
March 29, 2025 – Bagsværd, Denmark
In a groundbreaking development for the diabetes community, Novo Nordisk, a world-leading healthcare company, unveiled the full results from the SOUL (Semaglutide in Uncontrolled Type 2 Diabetes) cardiovascular outcomes trial. This trial demonstrated that Rybelsus®, an oral semaglutide medication, significantly reduced the risk of major adverse cardiovascular events in adults with type 2 diabetes and cardiovascular disease (CVD) and/or chronic kidney disease (CKD)1.
Presented at ACC’s Annual Scientific Session and Expo
These new data from the phase 3b trial were presented during a late-breaking clinical trial session at the American College of Cardiology’s (ACC) Annual Scientific Session and Expo in Chicago, US. Simultaneously, they were published today in the New England Journal of Medicine2.
Significant Reduction in Major Adverse Cardiovascular Events
In the SOUL trial, 3,297 participants were randomly assigned to receive Rybelsus® or placebo, in addition to standard care. Over a median follow-up period of 2.1 years, the trial reported a significant reduction in major adverse cardiovascular events (MACE) in the Rybelsus® group compared to the placebo group (HR 0.78, 95% CI 0.67 to 0.92, P<0.001)1. MACE included nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death.
Implications for People with Type 2 Diabetes and Cardiovascular Disease
For individuals with type 2 diabetes and a history of cardiovascular disease or chronic kidney disease, these findings represent a significant step forward in managing their health. The SOUL trial results suggest that Rybelsus® could help reduce the risk of cardiovascular events, offering hope for a better quality of life and improved long-term outcomes.
Global Impact on Diabetes Care
The implications of these findings extend beyond the individual level. With approximately 463 million people living with diabetes worldwide3, and an estimated 50% of them also having cardiovascular disease4, the potential impact of Rybelsus® on a global scale is immense. This could lead to significant reductions in healthcare costs and improved overall population health.
Conclusion
The SOUL trial results mark a major milestone in the ongoing quest to improve the lives of people with type 2 diabetes and cardiovascular disease. Rybelsus®, an oral semaglutide medication, has shown significant promise in reducing the risk of major adverse cardiovascular events in this population. These findings offer hope for better health outcomes and improved quality of life for millions of people worldwide. As the world continues to grapple with the growing diabetes epidemic, the potential impact of Rybelsus® on global healthcare is enormous.
- Novo Nordisk announces full results from the SOUL cardiovascular outcomes trial
- Rybelsus® (oral semaglutide) significantly reduces risk of major adverse cardiovascular events
- Findings presented at ACC’s Annual Scientific Session and Expo and published in New England Journal of Medicine
- Significant reduction in nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death
- Implications for individuals with type 2 diabetes, cardiovascular disease, and chronic kidney disease
- Potential global impact on diabetes care and healthcare costs
References:
1. Novo Nordisk A/S. SOUL: Semaglutide in Uncontrolled Type 2 Diabetes. 2025. Available at:
2. New England Journal of Medicine. Semaglutide and Cardiovascular Events in Type 2 Diabetes. 2025. Available at:
3. International Diabetes Federation. IDF Diabetes Atlas. 10th Edition. 2021. Available at:
4. American Heart Association. Heart Disease and Stroke Statistics – 2023 Update: A Report from the American Heart Association. 2023. Available at:
