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Novo Nordisk Oral Semaglutide Reaches Primary Endpoint in Phase 3 Study

Danish pharmaceutical company Novo Nordisk’s oral drug candidate semaglutide has met the primary endpoint in the Phase 3 Soul study. This is what a press release states.

The drug showed a statistically significant and greater reduction in major adverse cardiovascular events (MACE) of 14 percent for those treated with oral semaglutide compared to placebo.

The study included 9,650 people with type 2 diabetes and established chronic cardiovascular and/or kidney disease.

“The primary endpoint of the study was defined as the composite outcome of the first occurrence of a MACE defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. The three components of the primary endpoint contributed to the superior reduction in MACE demonstrated with oral semaglutide,” writes Novo Nordisk.

Novo Nordisk intends to file an application for an extension of indication for Rybelsus (a medicine for people with type 2 diabetes) in the United States and the European Union towards the end of the year.

Soul’s detailed results will be presented at a scientific conference in 2025.

Health

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