Cardiometabolic & kidney

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

LancetPublished Randomised controlled trial

Primary result · Maximum walking distance, ratio to baselineResult — go to the resultEstimated treatment ratio 1.13 95% CI 1.06–1.21

Authors' conclusion

Semaglutide increased walking distance in patients with symptomatic peripheral artery disease and type 2 diabetes.

Study context

Population
Adults with T2DM and PAD with intermittent claudication (Fontaine IIa, able to walk >200 m) and ankle-brachial index ≤0.90 or toe-brachial index ≤0.701,363 screened
Participants
792 adults
Comparison
Semaglutide vs placebo
  • Semaglutiden = 396
  • Placebon = 396reference
Primary endpoint
Ratio to baseline of maximum walking distance on a constant load treadmill (full analysis set)
Follow-up
Week 52
Methodological detailsphase 3b, double-blind, placebo-controlled, multicentre (112 sites, 20 countries)
  • Phase 3b
  • Double-blind
  • Placebo-controlled
  • Multicentre (112 sites, 20 countries)

Primary result

Maximum walking distance, ratio to baseline

Estimated treatment ratio

1.13

95% CI 1.06–1.21

P = 0.0004

By group

Semaglutide

1.21

median · IQR 0.95–1.55

Placebo

1.08

median · IQR 0.86–1.36

Semaglutide vs Placebo
estimated treatment ratio 1.13 (95% CI 1.06–1.21); P = 0.0004

As reported in the abstract

Further findings

Treatment-related deaths

No treatment-related deaths

Safety

Serious adverse events possibly or probably treatment related · safety analysis set

Events Semaglutide 6 · Placebo 9

Serious gastrointestinal events (treatment related)

Events Semaglutide 2 · Placebo 5

Original publication

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. Published 29 March 2025. doi:10.1016/s0140-6736(25)00509-4

Summarised from the published abstract; every number is checked against it

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