Novo Nordisk A/S (NVO) revealed on Monday the notable outcomes of the SOUL cardiovascular outcomes trial, successfully reaching its primary goal. This study highlighted that oral semaglutide reduced the risk of major adverse cardiovascular events by 14% in adults suffering from type 2 diabetes.
The company intends to seek regulatory approval to extend the indications for Rybelsus in both the United States and the European Union by the end of the year.
Currently, oral semaglutide, marketed under the name Rybelsus, is approved for daily administration in doses of 3 mg, 7 mg, and 14 mg.
This double-blind, randomized trial measured oral semaglutide against a placebo, supplementing standard care for preventing major adverse cardiovascular events (MACE).
The trial involved 9,650 participants with type 2 diabetes, alongside established cardiovascular disease (CVD) and/or chronic kidney disease (CKD). Throughout the study, 49% of patients received SGLT2 inhibitors as part of the standard care regimen.
Results indicated a statistically significant 14% reduction in MACE for those who received oral semaglutide compared to the placebo group. The primary objective was the composite of the first occurrence of MACE, defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke.
Novo Nordisk highlighted that each component of this primary endpoint contributed to the superior reduction in MACE observed with oral semaglutide.
Importantly, the trial affirmed the safety and tolerability of oral semaglutide, consistent with previous studies of the medication.
The company is set to present a comprehensive analysis of the SOUL trial results at a scientific conference in 2025.
