Novo Nordisk: Oral semaglutide reduces major cardiovascular events by 14% in type 2 diabetes SOUL trial

Bagsværd, Denmark, 21 October 2024 — Novo Nordisk revealed the headline findings from the SOUL cardiovascular outcomes study. This double-blind, randomized trial assessed the efficacy of oral semaglutide compared to a placebo when added to standard care for preventing major adverse cardiovascular events (MACE). The study included 9,650 participants with type 2 diabetes and established cardiovascular disease (CVD) and/or chronic kidney disease (CKD). Throughout the trial, 49% of patients received SGLT2 inhibitors as part of their standard care.

The primary goal of the trial was achieved, showing a statistically significant 14% reduction in MACE for those treated with oral semaglutide compared to the placebo. The primary endpoint of the study was a composite of the first occurrence of MACE, defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. All three components contributed to the notable reduction in MACE demonstrated by oral semaglutide.

Oral semaglutide was found to be safe and well-tolerated, consistent with results from previous trials involving the drug. "We are thrilled that the SOUL trial indicates oral semaglutide's ability to reduce cardiovascular events, adding benefits beyond the standard care," said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk. He emphasized the importance of having therapies that address both type 2 diabetes and cardiovascular disease, given that about one in three adults with type 2 diabetes also suffers from cardiovascular conditions.

Novo Nordisk plans to seek regulatory approval for a label expansion for Rybelsus® in both the US and EU around the end of the year. Detailed results from the SOUL trial will be presented at a scientific conference in 2025.

The SOUL trial was an international, multicenter, randomized, double-blind, parallel-group, placebo-controlled phase 3 cardiovascular outcomes study. It involved 9,650 participants and aimed to evaluate the impact of oral semaglutide versus placebo on cardiovascular outcomes in people with type 2 diabetes and established CVD and/or CKD. The trial began in 2019 with the primary objective of demonstrating that oral semaglutide reduces the risk of major adverse cardiovascular events compared to placebo, both added to standard care.

Rybelsus® is the brand name for oral semaglutide, which is taken once daily and approved in doses of 3 mg, 7 mg, and 14 mg. It is used to improve glycemic control in adults with insufficiently controlled type 2 diabetes, alongside diet and exercise. In the EU, a new formulation with doses of 1.5 mg, 4 mg, and 9 mg has been approved and is bioequivalent to the original formulation.

Novo Nordisk, a leading global healthcare company founded in 1923 and headquartered in Denmark, aims to drive change to defeat serious chronic diseases. The company is known for pioneering scientific breakthroughs, expanding access to medicines, and working towards the prevention and ultimate cure of diseases. Novo Nordisk employs approximately 69,000 people across 80 countries and markets its products in about 170 countries. Its B shares are listed on Nasdaq Copenhagen, and its American Depositary Receipts (ADRs) are listed on the New York Stock Exchange.