Ozempic’s Sister Drug Reduces Cardiovascular Risk by 14 Percent in Large-Scale Trial

Learn about the study’s possible impact on treatment strategies.

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Rybelsus, the sister drug of the popular Type 2 diabetes drug Ozempic, reduces the risk of serious heart problems by 14 percent, manufacturer Novo Nordisk announced on Monday.

Novo Nordisk is also the maker of the injectable weight-loss drug Wegovy.

The trial enrolled nearly 9,700 Type 2 diabetes patients who also had heart or kidney disease.

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People with Type 2 diabetes face a two to four times higher risk of developing cardiovascular disease than those without it. This increased risk stems from diabetes-related damage to blood vessels, elevated blood pressure, and abnormal cholesterol levels caused by high blood sugar.

The SOUL Trial: Design and Findings

Novo Nordisk’s SOUL trial, a double-blind, randomized study, evaluated the efficacy of oral semaglutide as an addition to standard care in nearly 9,700 participants with established cardiovascular disease or chronic kidney disease.

Approximately half of the participants were already receiving a sodium-glucose co-transporter-2 inhibitor (SGLT2i), a class of drugs that lower blood sugar levels, as part of their standard treatment. The results showed that adding oral semaglutide not only complemented these existing treatments but also enhanced cardiovascular protection.

The trial measured three primary outcomes: cardiovascular death, nonfatal heart attack, and nonfatal stroke. Results showed a statistically significant 14 percent reduction in these major adverse cardiovascular events among patients receiving oral semaglutide compared to those on placebo.

Safety and Future Plans

“We are pleased to see that the results from SOUL demonstrate that oral semaglutide reduces the risk of cardiovascular events and that the benefits of oral semaglutide come on top of standard of care,” Martin Holst Lange, executive vice president and head of development at Novo Nordisk, said in the press statement.

One-third of adults with Type 2 diabetes exhibit signs of undetected cardiovascular disease, compared to about 16 percent of people without diabetes, according to a 2023 study by the American Heart Association.

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The trial confirmed Rybelsus’ established safety profile, showing it remains well-tolerated by Type 2 diabetes patients. Based on these findings, Novo Nordisk plans to seek regulatory approval for a label expansion in the United States and European Union by the end of the year. Complete trial results will be presented at a scientific conference in 2025.

Rybelsus, approved by the U.S. Food and Drug Administration (FDA) in 2019 for the management of Type 2 diabetes, is administered once daily. The drug is designed to improve blood sugar control when combined with diet and exercise. In Europe, the drug is available in 1.5-milligram, 4-milligram, and 9-milligram doses.

As diabetes rates continue to rise worldwide, and given the overlapping risk for cardiovascular disease, the results of the SOUL trial could pave the way for new medical strategies that offer dual benefits for those living with these chronic conditions.