Already included in Israeli health baskets for all diabetics, the drug is expected to bolster the pharmaceutical company’s efforts to introduce more oral weight loss drugs in the coming years.
The US Food and Drug Administration (FDA) approved the oral Semaglutide, sold as Rybelsus by Novo Nordisk, six years ago for adults with type 2 diabetes. Two years ago, the FDA updated the label to allow first line use.
A study of the soul presented at the ACC conference in Chicago is the first to examine the cardiovascular benefits of oral glucagon-like peptide-1 (GLP-1) receptor agonists. The active ingredient in this drug mimics the human GLP-1 hormone and binds to its receptor.
The findings position Liberus as a potential alternative to injectable diabetes treatment. The mechanisms behind the cardiovascular benefits of GLP-1 are still under investigation, but researchers believe its anti-inflammatory properties play an important role.
“They’re also a part of the research,” said Dr. Darren K. McGuire, professor of medicine at the University of Texas Medical Center and lead researcher. “Whether you take it as a pill or as an injection, these drugs rapidly reduce systemic inflammation.”
Professor Michael Schector, director of clinical research at Sheba Medical Center, who led the Israeli Soul Research, emphasized the importance of the findings. “The 14% reduction in major cardiovascular risk is substantial. For comparison, given that risk reduction by 15% every other week, a high cholesterol lowering injection,” he said.
“For the first time, there’s a simple, accessible, safe oral treatment that addresses both diabetes and cardiovascular disease.”
Phase 3 studies included type 9,650 diabetes patients with coronary artery disease, stroke, or chronic kidney disease. It began in 2019 and concluded in the second half of 2024. Of the participants, 70% had coronary artery disease, 42% had chronic kidney disease, 21% had a history of stroke, and 15.7% had peripheral vascular disease.
Additionally, one in four had heart failure. All patients received standard care, half were given Liberus and half were given a placebo.
“This is the first large international study to demonstrate that oral semaglutide significantly reduces cardiovascular and cerebrovascular events in patients with or without renal failure, with or without renal failure, during optimal treatment,” Schector said.
He added that Israel played an important role in the study, contributing 80 patients from eight medical centres. “One in three people with type 2 diabetes also have heart disease. It’s important to provide treatment that addresses both conditions,” he said.
Following the positive findings of the study, Novo Nordisk has announced plans to seek approval from US and EU regulators to expand the label for Liberus to reduce cardiovascular risk in adults with type 2 diabetes.
