Novo Nordisk On Saturday, diabetic tablet Libers said it showed cardiovascular benefits in late-stage trials, paving the way for it to become a new treatment option for people living with diabetes and heart disease.
The tablet reduced the risk of cardiovascular-related death, heart attacks and stroke by 14% compared to placebo after an average of 4 years, with or without chronic kidney disease, diabetics and heart disease. The Danish drugmaker presented its results at Rybelsus, already approved for type 2 diabetes, at the annual science session of American Cardiology in Chicago.
Novo Nordisk has already been applied to the US and the EU, and includes expanding pill approvals to reduce the risk of serious cardiovascular complications, said Stephen Gough, the company’s global chief medical officer, in an interview.
Rybelsus is a once-daily oral formulation of Ozempic, a hit diabetes injection from Novo Nordisk, taken once a week. Both treatments and the company’s weekly weight loss injection Wegovy contain the active ingredient semaglutide.
Wegovy received approval in March 2024 to significantly reduce the risk of major cardiovascular events in adults with cardiovascular disease and reduce the risk of obesity or overweight. However, pill data presented on Saturday suggests that patients who are injected sometime, such as patients who are afraid of needles, can quickly access treatment in a more convenient way.
“We know that not everyone wants an injection. They want oral medication options, whether it’s painful or not,” Gough told CNBC. “The option offers the option that patients and healthcare professionals can have either one depending on what they think is right in their joint discussion.”
The data comes as slates for other drug makers. Eli Lily, It works to develop oral GLP-1 for other conditions such as diabetes, weight loss, and sleep apnea.
The third-stage trial examined over 9,600 patients aged 50 and older who received either Liberus or placebo on a standard treatment regime, averaged <4 years. Almost half of all patients received a drug called SGLT2 inhibitors. This is used at some point during the trial to lower blood sugar levels, primarily in adults with type 2 diabetes.
By the end of the trial, 12% of people taking Rybelsus and 13.8% of people experiencing a placebo had a cardiovascular-related death, heart attack, or stroke. This represents a 14% lower overall risk among people who took Rybelsus.
Researchers said the reduced risk was consistent with cardiovascular benefits observed in eight previous trials, including injectable GLP-1, which includes semaglutide and other common drugs, according to a release from the American College of Heart. GLP-1 mimics certain intestinal hormones to suppress appetite and regulate blood glucose levels, but it also has other benefits such as reducing inflammation.
Liberus helped reduce the risk of non-fatal heart attacks by 26% compared to placebo. Placebo was the “major driver” for an overall reduction in the risk of cardiovascular complications in the trial. The tablet also reduced the risk of non-fatty stroke and cardiovascular-related death by 7% compared to placebo.
There was no significant difference between the liberus and placebo groups in the results related to renal function, Release added. However, the test was “clearly” designed to look at the cardiovascular rather than the kidney benefits of the pill, Gough said.
Ozempic is already approved for treating chronic kidney disease in diabetic patients.
The most common side effects reported in this study are gastrointestinal problems, such as nausea, diarrhea and constipation, and according to the release, patients rarely stopped taking Rybelsus. These symptoms are consistent with the side effects of injectable semaglutide.
Similar results were seen in all subgroups of patients – among people with different health conditions at the start of the trial, the release states.
Unlike its injectable counterparts, Rybelsus should be consumed on an empty stomach at least 30 minutes before breakfast with a small amount of water. Despite these requirements, the study provides “a sense of security that patients will be able to take the drug as directed and enjoy cardiovascular health benefits.”
