Novo Nordisk presented the full results from STRIDE, a phase 3b 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, US. These new data from the phase 3 trial were featured during a late-breaking clinical trial session at the ACC and simultaneously published now 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 meters 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 571. PAD is a severe form of atherosclerotic cardiovascular disease that is under-screened and underdiagnosed and impacts approximately 230 million people globally3. Type 2 diabetes is one of the leading risk factors for PAD, and nearly one in three people with PAD have type 2 diabetes4.
There are limited therapies available to specifically improve functional limitations in PAD, representing a significant unmet need in this population. 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. Based on data from the STRIDE clinical trial, Novo Nordisk submitted a label extension application for Ozempic® to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). A decision is anticipated in 2025.
STRIDE is a double-blind, randomised, placebo-controlled phase 3b 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. Lower extremity PAD is a severe form of atherosclerotic cardiovascular disease. The classical symptom is intermittent claudication, associated with limited walking ability and poor health-related quality of life.
Type 2 diabetes is one of the leading risk factors for PAD; nearly one in three people with PAD have type 2 diabetes4. While anti-atherosclerotic therapies and lifestyle changes are recommended, there are no effective therapies to specifically improve functional outcomes in PAD and type 2 diabetes. Ozempic® (semaglutide) injection 0.25, 0.5 mg, 1.0 mg or 2.0 mg is a once-weekly GLP-1 RA indicated, along with diet and exercise, to improve blood sugar (glucose) in adults with type 2 diabetes mellitus and to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease.
Ozempic® is currently marketed in 75 countries and 7 million people with type 2 diabetes are currently being treated with Ozempic® worldwide.
