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