Ozempic (once-weekly semaglutide 1.0 mg) shown to improve walking distance and quality of life in adults with type 2 diabetes and peripheral artery disease (PAD) at ACC 2025- Novo Nordisk

Novo Nordisk  presented the full results from STRIDE, a phase III  peripheral artery disease (PAD) outcomes trial investigating the effects of once-weekly injectable Ozempic (semaglutide 1.0 mg) in adults with type 2 diabetes and PAD, at the American College of Cardiology's (ACC) Annual Scientific Session and Expo in Chicago. These new data from the phase III trial were featured during a late-breaking clinical trial session at the ACC and simultaneously published  in The Lancet..  

The double-blind, randomised, placebo-controlled STRIDE trial achieved its primary endpoint, with semaglutide 1.0 mg demonstrating a superior and clinically meaningful improvement of 13% in maximum walking distance and a mean treatment difference of 39.9 m on a steep incline, compared to placebo at week 52. The trial also demonstrated superiority to placebo for all confirmatory secondary outcomes assessed, including pain-free walking distance at week 52, health-related quality of life (Vascular Quality of Life Questionnaire-6) at week 52, and maximum walking distance at week 57.

The safety results from the STRIDE trial are consistent with the well-established safety and tolerability profile of once-weekly semaglutide, supported by long-term safety data with more than 33 million patient-years of exposure. Serious adverse events (SAEs) were reported in fewer participants in the semaglutide group than in the placebo group (74 [19%] vs 78 [20%]). SAE probably related to treatment occurred in 2 participants (1%) in the semaglutide group and in 2 participants (1%) in the placebo group. SAE possibly related to treatment occurred in 3 (1%) and 4 (1%) participants, respectively. SAEs leading to permanent treatment discontinuation of semaglutide or placebo were less common in the semaglutide group than in the placebo group (11 [3%] vs 13 [3%]). SAEs led to the death of 3 (1%) and 8 (2%) participants in the semaglutide and placebo arms, respectively; however, no SAEs leading to death were treatment-related.

STRIDE is a double-blind, randomised, placebo-controlled phase IIIb clinical trial assessing the benefit of once-weekly injectable semaglutide 1.0 mg, marketed as Ozempic, on functional capacity. It enrolled 792 participants with type 2 diabetes and symptomatic PAD with walking-induced leg pain. The primary endpoint was maximum walking distance on a constant load treadmill for people treated with semaglutide compared to placebo at week 52. STRIDE is the only dedicated PAD functional outcomes trial with a GLP-1 RA.

Based on data from the STRIDE clinical trial, Novo Nordisk submitted a label extension application for Ozempic to the EMA and the FDA. A decision is anticipated in 2025.

"Peripheral artery disease (PAD) may cause severe symptoms, physical limitations, and a diminished quality of life, often making even short walks, such as retrieving the mail challenging. In individuals with PAD and diabetes, the disease can be even more severe, affecting small blood vessels and limiting the effectiveness of revascularization procedures and other treatments. Semaglutide 1.0 mg is the first medication in over two decades to show improvements in cardiometabolic and cardiovascular outcomes as well as meaningful improvements in functional capacity and quality of life, which could address a critical unmet need for those with both PAD and type 2 diabetes," said Dr. Marc P. Bonaca, Director of Vascular Research, University of Colorado School of Medicine, Lead Investigator of the STRIDE trial. “The significant improvements in walking distance and patient-reported quality of life observed with semaglutide 1.0 mg in the STRIDE trial are promising and represent an important step forward on the path to advancing treatment options for this patient population.”

"Novo Nordisk continues to evolve its focus beyond diabetes and obesity towards a broader spectrum of metabolic and cardiovascular health,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk. “These data, alongside other data being presented at ACC, reinforce the comprehensive set of health benefits of semaglutide, making it a strong option for healthcare professionals addressing the spectrum of metabolic and cardiovascular health – and our continued leadership in the space.”

See citation- Bonaca MP, Catarig AM, Houlind K et al. Semaglutide and walking capacity in people with symptomatic peripheral artery disease and type 2 diabetes (STRIDE): a phase 3b, double-blind, randomised, placebo-controlled trial. Lancet . 2025 Mar 28:S0140-6736(25)00509-4. doi: 10.1016/S0140-6736(25)00509-4. Online ahead of print.