Novo announces Phase 3 success for oral GLP-1 cardiac trial

Novo Nordisk recently announced that its oral semaglutide, marketed as Rybelsus, has shown promising results in reducing the risk of significant heart events in individuals with type 2 diabetes and associated metabolic conditions. This development from a late-phase study may lead to a label expansion for this non-injectable GLP-1 medication.

The Danish pharmaceutical giant's oral semaglutide successfully achieved the primary endpoint in the Phase 3 SOUL trial, which involved 9,650 participants. The study demonstrated a roughly 14% reduction in major adverse cardiovascular events (MACE) for those taking Rybelsus compared to a placebo. The classification of MACE in the study encompassed cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.

Though comprehensive data from the trial will not be available until next year, Novo Nordisk plans to present the full results at a forthcoming medical conference. Despite the wait, the company intends to submit the data to regulatory authorities in the United States and the European Union by the end of the year.

The SOUL trial specifically targeted individuals with type 2 diabetes who also had cardiovascular disease or chronic kidney disease. Nearly half of the participants were on standard SGLT2 inhibitors at some point during the study, as reported by the company.

Rybelsus originally received approval from the FDA in 2019 for the treatment of type 2 diabetes. Given the prevalence of coexisting diabetes and cardiovascular disease in the adult population, the need for treatments addressing both conditions is critical. Martin Holst Lange, Novo Nordisk's head of development, highlighted the importance of such treatment options in the company's recent release.

In financial terms, Rybelsus has performed well, with sales increasing by nearly 50% in the second quarter compared to the same period last year, reaching DKK 5.9 billion (approximately $858 million). Concurrently, Novo Nordisk's injectable semaglutide, marketed as Wegovy for weight loss, generated DKK 11.7 billion ($1.7 billion) in sales during the second quarter.

In March, the FDA approved Wegovy to lower the risk of cardiovascular death, heart attack, and stroke in adults with heart disease who are either obese or overweight. This approval prompted Medicare Part D to begin covering Wegovy for specific patients, a significant policy shift for public payers that had previously excluded weight loss medications from coverage.