In 20 countries throughout North America, Asia, and Europe, 112 outpatient clinical trial sites participated in the STRIDE study. The participants were of at least 18 year old who had peripheral artery disease, type 2 diabetes, intermittent claudication (Fontaine stage IIa, able to walk >200 m), and an ankle-brachial index of less than or equal to 0·90 or 0·70.
Using an interactive online response system, the participants were randomly randomized (1:1) to receive either a placebo or subcutaneous semaglutide 1·0 mg once weekly for 52 weeks. The ratio to baseline of the maximal walking distance at week 52, as determined by a constant load treadmill in the whole study set, served as the main endpoint.
After 1,363 individuals were evaluated for eligibility between October 1, 2020, and July 12, 2024, 792 of them were randomized to receive either semaglutide (n=396) or a placebo (n=396). Of the participants, 597 (75%) were men and 195 (25%) were women. The median age (IQR 61·0–73·0) was 68·0 years.
The semaglutide group outperformed the placebo group in terms of the estimated median ratio to baseline in maximum walking distance at week 52 (1·21 [IQR 0·95–1·55] vs. 1·08 [0·86–1·36]; estimated treatment ratio 1·13 [95% CI 1·06–1·21]; p=0·0004). The most common adverse event was a serious gastrointestinal event (two events reported by two [1%] in the semaglutide group and five events reported by three [1%] in the placebo group).
Additionally, 6 serious adverse events in 5 (1%) participants in the semaglutide group and 9 serious adverse events in 6 (2%) participants in the placebo group were possibly or probably related to treatment. No one died as a result of therapy. Overall, walking distance was considerably enhanced with semaglutide when compared to a placebo.
Source:
Bonaca, M. P., Catarig, A.-M., Houlind, K., Ludvik, B., Nordanstig, J., Ramesh, C. K., Rasouli, N., Sourij, H., Videmark, A., Verma, S., & STRIDE Trial Investigators. (2025). 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, 405(10489), 1580–1593. https://doi.org/10.1016/S0140-6736(25)00509-4
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