The findings of a new analysis from the STRIDE trial, presented at the American Diabetes Association (ADA) 2025 scientific session (20–23 June, Chicago, USA) and published in Diabetes Care, demonstrate the potential vascular benefits of semaglutide in patients with peripheral artery disease (PAD) and type 2 diabetes, including improvement in symptoms, quality of life, and disease progression in patients.
STRIDE is a phase 3, multinational, double-blind, randomised clinical trial conducted at 112 outpatient clinical trial sites in 20 countries in North America, Asia, and Europe.
Researchers enrolled 792 patients aged 18 years and older with type 2 diabetes and PAD with intermittent claudication and reduced ankle-brachial or toe-brachial index.
Patients were randomly assigned to receive either semaglutide (n=396) or placebo (n=396) over a 52-week period to assess the impact on walking capacity, symptoms, and quality of life. The median age was 68 years, and 195 (25%) participants were female and 597 (75%) were male.
The sub-analysis builds on results previously presented at the American College of Cardiology (ACC) 2025 scientific session (29–31 March, Chicago, USA) and published in The Lancet, demonstrating that semaglutide significantly improved walking outcomes in people with PAD and diabetes, enhanced quality of life, and reduced the risk of disease progression by 54%.
At week 52, the estimated median ratio to baseline in maximum walking distance was 1.21 in the semaglutide group compared to 1.08 in the placebo group. Semaglutide was well tolerated, with no treatment-related deaths and a low rate of serious adverse events (1%), consistent with its known safety profile.
The analyses from STRIDE presented new and critical information on the benefits of semaglutide, which were observed independent of baseline levels of A1C, duration of diabetes, or intensity of diabetes, ADA said in a press release. Furthermore, the benefits were seen across all body mass index BMI categories and regardless of the treatment with SGLT2 inhibitors.
“These findings indicate that clinicians can now recognise semaglutide as a vascular protective medication, with benefits that extend beyond lowering weight or A1C,” said Subodh Verma (University of Toronto, Toronto, Canada), senior author of the STRIDE trial. “The totality of data now suggest that in people with diabetes, semaglutide favourably affects the pipes [atherosclerosis], pump [heart failure], filter [kidney outcomes]. And, in patients with PAD, these new data provide robust evidence that semaglutide is a therapy to improve their function, quality of life, and progression of disease.”
The study authors indicate that further research is warranted to understand whether these benefits extend to individuals with PAD who do not have diabetes.