Novo Nordisk’s Oral Semaglutide Reduces Cardiovascular Risk by 14% in Type 2 Diabetes Patients, SOUL Trial Shows

Novo Nordisk’s Oral Semaglutide Reduces Cardiovascular Risk by 14% in Type 2 Diabetes Patients, SOUL Trial Shows

(IN BRIEF) Novo Nordisk’s SOUL trial has shown that oral semaglutide reduces the risk of major adverse cardiovascular events (MACE) by 14% in adults with type 2 diabetes and established cardiovascular disease or chronic kidney disease. The trial involved 9,650 participants and demonstrated that oral semaglutide, in addition to standard care, significantly lowers the likelihood of cardiovascular death, heart attack, and stroke. The drug was found to be safe and well-tolerated, and Novo Nordisk plans to seek regulatory approval for a label expansion for Rybelsus® in the US and EU.

(PRESS RELEASE) BAGSVÆRD, 21-Oct-2024 — /EuropaWire/ — Novo Nordisk has announced positive results from the SOUL cardiovascular outcomes trial, which evaluated the effects of oral semaglutide in adults with type 2 diabetes. The randomized, double-blind study included 9,650 participants with either established cardiovascular disease (CVD) or chronic kidney disease (CKD), assessing the drug’s impact on reducing major adverse cardiovascular events (MACE) compared to a placebo.

The trial successfully met its primary goal, showing a 14% reduction in the risk of MACE among patients treated with oral semaglutide. The study’s primary endpoint focused on the first occurrence of cardiovascular death, non-fatal heart attack, or non-fatal stroke, with all three contributing to the observed risk reduction.

Throughout the trial, oral semaglutide was found to be both safe and well-tolerated, aligning with results from earlier studies.

Martin Holst Lange, Novo Nordisk’s executive vice president and head of Development, remarked, “We are encouraged by these findings, as they demonstrate that oral semaglutide not only reduces cardiovascular risks but also provides additional benefits when used alongside standard care. Given that one in three adults with type 2 diabetes also suffers from cardiovascular disease, having treatments that address both is essential.”

Novo Nordisk plans to submit applications for regulatory approval of a label expansion for Rybelsus® in both the US and EU around the end of the year, with detailed trial results expected to be presented at a scientific conference in 2025.

About the SOUL trial
SOUL was a multicentre, international, randomised, double-blind, parallel-group, placebo-controlled, phase 3 cardiovascular outcomes trial with 9,650 people enrolled. It was conducted to assess the effect of oral semaglutide vs placebo on cardiovascular outcomes in people with type 2 diabetes and established CVD and/or CKD. The SOUL trial was initiated in 2019.

The key objective of SOUL was to demonstrate that oral semaglutide lowers the risk of major adverse cardiovascular events (a composite endpoint consisting of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke) compared to placebo, both added to standard of care in patients with type 2 diabetes and established CVD and/or CKD.

About Rybelsus®
Oral semaglutide is administered once daily and is approved for use in three doses, 3 mg, 7 mg and 14 mg, under the brand name Rybelsus®. It is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise. In the EU, a new formulation of 1.5 mg, 4 mg and 9 mg doses of Rybelsus® are approved and are bioequivalent to the original formulation of Rybelsus®.

1Based on treatment policy estimand: treatment effect regardless of treatment adherence

Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 69,000 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.

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SOURCE: Novo Nordisk