COPENHAGEN (dpa-AFX) - Novo Nordisk A/S (NVO) announced Monday the headline results from the SOUL cardiovascular outcomes trial, which achieved its primary objective. In the trial, oral semaglutide demonstrated a 14% reduction in risk of major adverse cardiovascular events in adults with type 2 diabetes.
Novo Nordisk said it expects to file for regulatory approval of a label expansion for Rybelsus in both the US and EU around the turn of the year.
Oral semaglutide is administered once daily and is approved for use in three doses, 3 mg, 7 mg and 14 mg, under the brand name Rybelsus.
The double-blinded, randomised trial compared oral semaglutide to placebo as an adjunct to standard of care for the prevention of major adverse cardiovascular events or MACE.
The trial enrolled 9,650 people with type 2 diabetes and established cardiovascular disease or CVD and/or chronic kidney disease or CKD. As part of standard of care, 49% of patients received SGLT2i at some point during the trial.
The trial demonstrated a statistically significant and superior reduction in MACE of 14% for people treated with oral semaglutide compared to placebo. The primary endpoint of the study was defined as the composite outcome of the first occurrence of MACE defined as cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.
The company noted that all three components of the primary endpoint contributed to the superior MACE reduction demonstrated by oral semaglutide.
In the trial, oral semaglutide appeared to have a safe and well-tolerated profile in line with previous oral semaglutide trials.
The company plans to present the detailed results from SOUL at a scientific conference in 2025.
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