Novo Nordisk on Monday reported the oral version of its drug semaglutide reduced the risk of major adverse cardiovascular events in adults with type 2 diabetes by 14% in a large Phase III trial.
Seven months after the FDA approved Novo Nordisk’s injectable Wegovy to reduce the risk of cardiovascular events in adults with heart disease who are overweight or obese, the Danish drugmaker is back with positive late-stage cardio results for its oral semaglutide formulation, Rybelsus.
In the Phase III SOUL trial, which compared Rybelsus to placebo, Novo’s drug elicited a 14% reduction in the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes.
The double-blinded, randomized trial enrolled 9,650 people with type 2 diabetes and established cardiovascular disease and/or chronic kidney disease, 49% of whom had been treated with sodium-glucose cotransporter-2 inhibitors (SGLT2i) as part of standard of care.
“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, said in a statement, noting that approximately one in three adults with type 2 diabetes also have cardiovascular disease.
Novo expects to present full detailed results from the trial at a scientific conference in 2025 and stated plans to file for a label expansion for Rybelsus in both the U.S. and EU around the end of 2024.
Rybelsus, which is taken once daily, was approved by the FDA in September 2019 as the first oral GLP-1 treatment for type 2 diabetes.
Monday’s data readout marks the second cardiovascular win this year for Novo’s GLP-1 franchise. In March, the FDA granted a label expansion for weight-loss drug Wegovy to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and who are obese or overweight.
The approval was based on results that showed Wegovy reduced the risk of MACE in 6.5% of trial participants compared to 8% of their placebo counterparts. With the nod, Wegovy became the first weight-loss medication to also be approved to help prevent life-threatening cardiovascular events in this patient population.
Novo and rival type 2 diabetes and obesity competitor Eli Lilly are attempting to push their GLP-1 drugs into new indications, including heart failure with preserved ejection fraction, sleep apnea, and metabolic dysfunction-associated steatohepatitis.
