STRIDE

CompletedPhase 3Results posted

A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes

Effects of Semaglutide on Functional Capacity in Patients With Type 2 Diabetes and Peripheral Arterial Disease

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

194

Recruiting sites

—

Enrollment

792

actual

Study population

Cardiovascular disease, Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•Maximum Walking Distance on a Constant Load Treadmill Test

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04560998

Org study IDNN9535-4533

Secondary ID2019-003399-38European Medicines Agency (EudraCT)

Secondary IDU1111-1238-7071World Health Organization (WHO)

Timeline

Milestones

Study first posted2020-09-23actual

Study start2020-10-01actual

Primary completion2024-06-05actual

Study completion2024-07-12actual

Results first posted2025-07-08actual

Last update posted2025-12-12actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Cardiovascular diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female, age above or equal to 18 years at the time of signing informed consent. For Japan: Male or female, age above or equal to 20 years at time of signing informed consent

•Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening.

•Symptomatic PAD with intermittent claudication corresponding to Fontaine stage IIa (Rutherford classification grade I, category 1 and 2) meeting all of the following:

1. Stable symptoms of PAD with intermittent claudication in Fontaine stage IIa (able to walk without stopping more than 200 m/656 feet/2 blocks) for at least 90 days prior to the day of screening based on patient interview.

2. Screening flat treadmill test (3.2 km/h (2 mph)): Pain-free walking distance of at least 200 meters/656 feet.

3. Screening constant load treadmill test with fixed inclination of 12% and a fixed speed of 3.2 km/h (2 mph): Walking distance equal to or less than 600 meters/1968 feet.

4. Ankle-brachial-index (ABI) equal to or below 0.90 or toe-brachial index (TBI) equal to or below 0.7 (the leg with lowest index is chosen in case of bilateral disease).

Exclusion criteria

•Current or previous treatment with any GLP-1 receptor agonist (GLP-1-RA) within 90 days prior to the day of screening.

•Walking ability limited by conditions other than PAD (e.g. aortic aneurism, dysregulated arrhythmia or hypertension, angina pectoris, heart failure, chronic obstructive or restrictive pulmonary disease, Parkinson's disease, severe peripheral neuropathy, amputations, wheel chair or walker dependency, osteoarthritis, morbid obesity, severe varicose veins, etc.).

•Planned orthopaedic surgery in the legs, or other major surgery known on the day of screening (surgery affecting walking ability).

•Vascular revascularisation procedure of any kind 180 days prior to the day of screening.

•Planned arterial revascularisation known on the day of screening.

•Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischemic attack within 180 days prior to the day of screening.

•Heart failure presently classified as being in New York Heart Association (NYHA) class III-IV.

Endpoints (32)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Patient-reported / QoL

Cardiovascular outcomes

Other clinical outcomes

Weight & body composition

Glycemic / diabetes

Cardiovascular outcomes

4 endpoints

Primary/protocol endpoint

Change in Maximum Walking Distance on a Constant Load Treadmill Test

Time frame:Baseline (week 0), end of treatment (week 52)

change from baseline, improvement

Secondary/registry result/low confidence

Follow-up Change in Maximum Walking Distance on a Constant Load Treadmill Test

Time frame:Baseline (week 0), end of follow-up (week 57)

change from baseline, improvement

Posted result

Group	Value (median), Ratio of maximum walking distance	95% CI
Semaglutide	1.16	0.92 – 1.48
Placebo	1.10	0.87 – 1.40

The Hodges-Lehmann estimate1.0895% CI1.004 – 1.156p0.0380Wilcoxon (Mann-Whitney)

Secondary/registry result

Follow-up Change in Pain-free Walking Distance on a Constant Load Treadmill Test

Time frame:Baseline (week 0), end of follow-up (week 57)

ratio, improvement

Posted result

Group	Value (median), Ratio of pain-free walking distance	95% CI
Semaglutide	1.18	0.92 – 1.59
Placebo	1.10	0.83 – 1.48

Secondary/protocol endpoint/low confidence

Follow-up Change in Maximum Walking Distance on a Constant Load Treadmill Test

Time frame:Baseline (week 0), end of follow-up (week 57)

change from baseline, improvement

Weight & body composition

2 endpoints

Secondary/registry result

Change in Body Weight

Time frame:Baseline (week 0), end of treatment (week 52)

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kilogram (kg)	95% CI
Semaglutide	-5.2	—
Placebo	-1.2	—

Secondary/protocol endpoint

Change in Body Weight

Time frame:Baseline (week 0), end of treatment (week 52)

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/registry result

Change in Glycosylated Haemoglobin (HbA1c)

Time frame:Baseline (week 0), end of treatment (week 52)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage-point of HbA1c	95% CI
Semaglutide	-0.8	—
Placebo	0.2	—

Secondary/protocol endpoint

Change in Glycosylated Haemoglobin (HbA1c)

Time frame:Baseline (week 0), end of treatment (week 52)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

14 endpoints

Secondary/registry result

Change in Systolic Blood Pressure

Time frame:Baseline (week 0), end of treatment (week 52)

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), Millimetre of mercury (mmHg)	95% CI
Semaglutide	-4	—
Placebo	-1	—

Secondary/registry result

Change in Total Cholesterol

Time frame:Baseline (week 0), end of treatment (week 52)

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

Group	Value (geometric_mean), Ratio of total cholesterol	95% CI
Semaglutide	0.96	—
Placebo	1.00	—

Secondary/registry result

Change in Low-density Lipoprotein (LDL)-Cholesterol

Time frame:Baseline (week 0), end of treatment (week 52)

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

Group	Value (geometric_mean), Ratio of LDL	95% CI
Semaglutide	0.99	—
Placebo	1.03	—

Secondary/registry result

Change in High Density Lipoprotein (HDL)-Cholesterol

Time frame:Baseline (week 0), end of treatment (week 52)

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

Group	Value (geometric_mean), Ratio of HDL	95% CI
Semaglutide	1.04	—
Placebo	0.99	—

Secondary/registry result

Change in Triglycerides

Time frame:Baseline (week 0), end of treatment (week 52)

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (geometric_mean), Ratio of triglycerides	95% CI
Semaglutide	0.80	—
Placebo	0.95	—

Secondary/registry result

Change in Ankle-Brachial Index (ABI)

Time frame:Screening (week -2), end of treatment (week 52)

change from baseline, improvement

Posted result

Group	Value (geometric_mean), Ratio of ABI	95% CI
Semaglutide	1.06	—
Placebo	1.02	—

Secondary/registry result

Change in Toe-Brachial Index (TBI)

Time frame:Screening (week -2), end of treatment (week 52)

change from baseline, improvement

Posted result

Group	Value (geometric_mean), Ratio of TBI	95% CI
Semaglutide	1.07	—
Placebo	1.04	—

Secondary/protocol endpoint

Change in Systolic Blood Pressure

Time frame:Baseline (week 0), end of treatment (week 52)

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in Total Cholesterol

Time frame:Baseline (week 0), end of treatment (week 52)

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in Low-density Lipoprotein (LDL)-Cholesterol

Time frame:Baseline (week 0), end of treatment (week 52)

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in High Density Lipoprotein (HDL)-Cholesterol

Time frame:Baseline (week 0), end of treatment (week 52)

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in Triglycerides

Time frame:Baseline (week 0), end of treatment (week 52)

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in Ankle-Brachial Index (ABI)

Time frame:Screening (week -2), end of treatment (week 52)

change from baseline, improvement

Secondary/protocol endpoint

Change in Toe-Brachial Index (TBI)

Time frame:Screening (week -2), end of treatment (week 52)

change from baseline, improvement

Patient-reported / QoL

6 endpoints

Secondary/registry result

Change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) Score

Time frame:Baseline (week 0), end of treatment (week 52)

change from baseline, improvement

Posted result

Group	Value (median), Scores on a scale	95% CI
Semaglutide	2.0	0.00 – 4.00
Placebo	1.0	-1.00 – 4.00

The Hodges-Lehmann estimate1.0095% CI0.478 – 1.518p0.0108Wilcoxon (Mann-Whitney)

Secondary/registry result

Change in Walking Impairment Questionnaire (WIQ) Global Score

Time frame:Baseline (week 0), end of treatment (week 52)

change from baseline, improvement

Posted result

Group	Value (mean), %-point scores on a scale	95% CI
Semaglutide	9.48	—
Placebo	6.51	—

Secondary/registry result

Change in Short Form 36 (SF-36) Physical Functioning Domain

Time frame:Baseline (week 0), end of treatment (week 52)

SF-36 physical

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	95% CI
Semaglutide	2.98	—
Placebo	1.52	—

Secondary/protocol endpoint

Change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) Score

Time frame:Baseline (week 0), end of treatment (week 52)

change from baseline, improvement

Secondary/protocol endpoint

Change in Walking Impairment Questionnaire (WIQ) Global Score

Time frame:Baseline (week 0), end of treatment (week 52)

change from baseline, improvement

Secondary/protocol endpoint

Change in Short Form 36 (SF-36) Physical Functioning Domain

Time frame:Baseline (week 0), end of treatment (week 52)

SF-36 physical

change from baseline, improvement

Other clinical outcomes

4 endpoints

Primary/registry result

Change in Maximum Walking Distance on a Constant Load Treadmill Test

Time frame:Baseline (week 0), end of treatment (week 52)

change from baseline, improvement

Posted result

Group	Value (median), Ratio of maximum walking distance	95% CI
Semaglutide	1.21	0.95 – 1.55
Placebo	1.08	0.86 – 1.36

The Hodges-Lehmann estimate1.1395% CI1.056 – 1.211p0.0004Wilcoxon (Mann-Whitney)

Secondary/registry result

Change in Pain-free Walking Distance on a Constant Load Treadmill Test

Time frame:Baseline (week 0), end of treatment (week 52)

ratio, improvement

Posted result

Group	Value (median), Ratio of pain-free walking distance	95% CI
Semaglutide	1.21	0.92 – 1.52
Placebo	1.10	0.86 – 1.44

The Hodges-Lehmann Estimate1.1195% CI1.033 – 1.197p0.0046Wilcoxon (Mann-Whitney)

Secondary/protocol endpoint

Change in Pain-free Walking Distance on a Constant Load Treadmill Test

Time frame:Baseline (week 0), end of treatment (week 52)

change from baseline, improvement

Secondary/protocol endpoint

Follow-up Change in Pain-free Walking Distance on a Constant Load Treadmill Test

Time frame:Baseline (week 0), end of follow-up (week 57)

change from baseline, improvement

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Benefit of Semaglutide in Symptomatic Peripheral Artery Disease by Baseline Type 2 Diabetes Characteristics: Insights From STRIDE, a Randomized, Placebo-Controlled, Double-Blind Trial.
Diabetes care2025 Sep 1PMID40543068doi:10.2337/dc25-1082via pubmed nct search
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 (London, England)2025 May 3PMID40169145doi:10.1016/S0140-6736(25)00509-4via clinicaltrials gov reference derived + pubmed nct search
Design and baseline characteristics of the STRIDE trial: evaluating semaglutide in people with symptomatic peripheral artery disease and type 2 diabetes.
European heart journal. Cardiovascular pharmacotherapy2025 Jan 11PMID39424598doi:10.1093/ehjcvp/pvae071via pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.