{"protocolSection":{"identificationModule":{"nctId":"NCT04560998","orgStudyIdInfo":{"id":"NN9535-4533"},"secondaryIdInfos":[{"id":"2019-003399-38","type":"REGISTRY","domain":"European Medicines Agency (EudraCT)"},{"id":"U1111-1238-7071","type":"OTHER","domain":"World Health Organization (WHO)"},{"id":"2019","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2019"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes","officialTitle":"Effects of Semaglutide on Functional Capacity in Patients With Type 2 Diabetes and Peripheral Arterial Disease","acronym":"STRIDE"},"statusModule":{"statusVerifiedDate":"2026-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2020-10-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-06-05","type":"ACTUAL"},"completionDateStruct":{"date":"2024-07-12","type":"ACTUAL"},"studyFirstSubmitDate":"2020-09-18","studyFirstSubmitQcDate":"2020-09-18","studyFirstPostDateStruct":{"date":"2020-09-23","type":"ACTUAL"},"resultsFirstSubmitDate":"2025-06-03","resultsFirstSubmitQcDate":"2025-07-07","resultsFirstPostDateStruct":{"date":"2025-07-08","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-05-18","lastUpdatePostDateStruct":{"date":"2026-06-05","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This study is done to see if semaglutide has an effect on walking ability compared with placebo (dummy medicine) in people with peripheral arterial disease (PAD) and type 2 diabetes. Participants will either get semaglutide or placebo (\"dummy\") medicine - which treatment participants get is decided by chance. Semaglutide is a medicine for type 2 diabetes that can be prescribed by doctors in some countries. Participants will get the study medicine (semaglutide or placebo) in a pre-filled pen for injection. Participants must inject it once a week into the stomach area, thigh, or upper arm, at any time of the day. The study will last for about 59 weeks. Participants will have 8 clinic visits and 1 phone call with the study doctor. At some clinic visits, participants will have blood tests. At some visits participants will also do a treadmill test to measure how far they can walk. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period."},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2","Peripheral Arterial Disease"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","maskingDescription":"Sponsor staff involved in the clinical trial is masked according to company standard procedures.","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":792,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide","type":"EXPERIMENTAL","description":"Semaglutide given in addition to standard-of-care treatment","interventionNames":["Drug: Semaglutide"]},{"label":"Placebo (semaglutide)","type":"PLACEBO_COMPARATOR","description":"Placebo given in addition to standard-of-care treatment","interventionNames":["Drug: Placebo (semaglutide)"]}],"interventions":[{"type":"DRUG","name":"Semaglutide","description":"Semaglutide is administered subcutaneously (s.c.; under the skin) once-weekly for 52 weeks in a dose escalating manner: 0.25 mg from week 1 to week 4, 0.5 mg from week 5 to week 8 and 1.0 mg from week 9 to week 52.","armGroupLabels":["Semaglutide"]},{"type":"DRUG","name":"Placebo (semaglutide)","description":"Placebo (semaglutide) is administered s.c. once-weekly for 52 weeks in a dose escalating manner: 0.25 mg from week 1 to week 4, 0.5 mg from week 5 to week 8 and 1.0 mg from week 9 to week 52.","armGroupLabels":["Placebo (semaglutide)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Maximum Walking Distance on a Constant Load Treadmill Test","description":"Change in maximum walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants continue on the treadmill after indicating onset of pain and should continue as long as possible until pain limits further activity. This distance is noted as the maximum walking distance. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.","timeFrame":"Baseline (week 0), end of treatment (week 52)"}],"secondaryOutcomes":[{"measure":"Follow-up Change in Maximum Walking Distance on a Constant Load Treadmill Test","description":"Change in maximum walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants continue on the treadmill after indicating onset of pain and should continue as long as possible until pain limits further activity. This distance is noted as the maximum walking distance. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, which-ever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.","timeFrame":"Baseline (week 0), end of follow-up (week 57)"},{"measure":"Change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) Score","description":"Change in VascuQoL-6 score is presented. VascuQoL-6 is a peripheral artery disease-specific questionnaire with 6 items covering social, emotional, functional as well as pain- and symptom-related aspects of the patient´s overall quality of life. Each item has a 4-point response scale (where 1 = worst score and 4 = best score). The endpoint analysed is the total score (range: 6-24) generated by summing the scores from all items. A higher score indicates better health status. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.","timeFrame":"Baseline (week 0), end of treatment (week 52)"},{"measure":"Change in Pain-free Walking Distance on a Constant Load Treadmill Test","description":"Change in pain-free walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants are instructed to when pain starts in either leg and to continue on the treadmill without stopping at this stage. The distance walked is noted as the pain-free walking distance. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.","timeFrame":"Baseline (week 0), end of treatment (week 52)"},{"measure":"Follow-up Change in Pain-free Walking Distance on a Constant Load Treadmill Test","description":"Change in pain-free walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants are instructed to when pain starts in either leg and to continue on the treadmill without stop-ping at this stage. The distance walked is noted as the pain-free walking distance. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.","timeFrame":"Baseline (week 0), end of follow-up (week 57)"},{"measure":"Change in Glycosylated Haemoglobin (HbA1c)","description":"Change in HbA1c from baseline to week 52 in percentage-point is presented. The outcome measure is evaluated based on the on treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).","timeFrame":"Baseline (week 0), end of treatment (week 52)"},{"measure":"Change in Body Weight","description":"Change in body weight from baseline to week 52 in kilogram (kg) is presented. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).","timeFrame":"Baseline (week 0), end of treatment (week 52)"},{"measure":"Change in Systolic Blood Pressure","description":"Change in systolic blood pressure from baseline to week 52 is presented.The outcome measure is evaluated based on the on treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).","timeFrame":"Baseline (week 0), end of treatment (week 52)"},{"measure":"Change in Total Cholesterol","description":"Change in total cholesterol from baseline to week 52 is presented as ratio to baseline. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).","timeFrame":"Baseline (week 0), end of treatment (week 52)"},{"measure":"Change in Low-density Lipoprotein (LDL)-Cholesterol","description":"Change in LDL-cholesterol from baseline to week 52 is presented as ratio to baseline. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).","timeFrame":"Baseline (week 0), end of treatment (week 52)"},{"measure":"Change in High Density Lipoprotein (HDL)-Cholesterol","description":"Change in HDL-cholesterol from baseline to week 52 is presented as ratio to baseline. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).","timeFrame":"Baseline (week 0), end of treatment (week 52)"},{"measure":"Change in Triglycerides","description":"Change in Triglycerides from baseline to week 52 is presented as ratio to baseline. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).","timeFrame":"Baseline (week 0), end of treatment (week 52)"},{"measure":"Change in Ankle-Brachial Index (ABI)","description":"Change in ABI from baseline to week 52 is presented. ABI is calculated as a ratio of the higher ankle systolic pressure to the higher systolic pressure measured in both arms. ABI is measured at both left and right leg and the analysis endpoint is defined as the lower of the two indices. An ABI between 1.0 to 1.4 is considered the normal range. An ABI between 0.90 to 0.99 is considered borderline. An ABI less than 0.90 indicates peripheral artery disease (PAD). The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).","timeFrame":"Screening (week -2), end of treatment (week 52)"},{"measure":"Change in Toe-Brachial Index (TBI)","description":"Change in TBI from baseline to week 52 is presented. TBI is calculated as a ratio of the toe systolic pressure to the higher systolic pressure measured in both arms. TBI is measured at both left and right leg and the analysis endpoint is defined as the lower of the two indices. A TBI range of above or equal to 0.7 is considered normal, whereas a TBI less than 0.7 is considered abnormal. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).","timeFrame":"Screening (week -2), end of treatment (week 52)"},{"measure":"Change in Walking Impairment Questionnaire (WIQ) Global Score","description":"Change in WIQ global score from baseline to week 52 is presented. WIQ consists of three domains, speed, distance, and stair climbing, consisting of in total 14 questions. Each response is weighted based on the difficulty of the task. Domain scores are determined by dividing the weighted answers by the maximum possible weighted score and multiplying by 100. Global score is calculated as the mean of the three domain scores (ranged from 0% to 100%). A global score of 0% represents inabil-ity to perform any of the tasks and 100% represents no difficulty with any of the tasks. Higher scores indicate better walking ability and less impairment. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).","timeFrame":"Baseline (week 0), end of treatment (week 52)"},{"measure":"Change in Short Form 36 (SF-36) Physical Functioning Domain","description":"Change in SF-36 physical functioning domain from baseline to week 52 is presented. SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2 (acute version) questionnaire measured 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). The 0-100 scale scores from the SF-36 were converted to norm-based scores (Range: 19.03 to 57.60) to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A positive change score indicates an improvement in participant health stats. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).","timeFrame":"Baseline (week 0), end of treatment (week 52)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* 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\n* Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening.\n* Symptomatic PAD with intermittent claudication corresponding to Fontaine stage IIa (Rutherford classification grade I, category 1 and 2) meeting all of the following:\n\n  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.\n  2. Screening flat treadmill test (3.2 km/h (2 mph)): Pain-free walking distance of at least 200 meters/656 feet.\n  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.\n  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).\n\nExclusion Criteria:\n\n* Current or previous treatment with any GLP-1 receptor agonist (GLP-1-RA) within 90 days prior to the day of screening.\n* 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.).\n* Planned orthopaedic surgery in the legs, or other major surgery known on the day of screening (surgery affecting walking ability).\n* Vascular revascularisation procedure of any kind 180 days prior to the day of screening.\n* Planned arterial revascularisation known on the day of screening.\n* Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischemic attack within 180 days prior to the day of screening.\n* Heart failure presently classified as being in New York Heart Association (NYHA) class III-IV.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Clinical Transparency (1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Cardiology, PC","city":"Birmingham","state":"Alabama","zip":"35211","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Cardiovascular Associates of the Southeast","city":"Birmingham","state":"Alabama","zip":"35243","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Univ of Alabama Birmingham","city":"Birmingham","state":"Alabama","zip":"35294","country":"United 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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. 2025 May 3;405(10489):1580-1593. doi: 10.1016/S0140-6736(25)00509-4. Epub 2025 Mar 29."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com","url":"http://novonordisk-trials.com"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants were randomized in a 1:1 ratio to receive treatment with either semaglutide or placebo as an adjunct to standard-of-care.","recruitmentDetails":"The trial was conducted at 129 sites in 21 countries.","groups":[{"id":"FG000","title":"Semaglutide","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg."},{"id":"FG001","title":"Placebo","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"396"},{"groupId":"FG001","numSubjects":"396"}]},{"type":"Full Analysis Set","comment":"FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation.","achievements":[{"groupId":"FG000","numSubjects":"396"},{"groupId":"FG001","numSubjects":"396"}]},{"type":"Safety Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"396"},{"groupId":"FG001","numSubjects":"395"}]},{"type":"COMPLETED","comment":"Participants attended follow-up visit or died during trial considered completers in the trial.","achievements":[{"groupId":"FG000","numSubjects":"366"},{"groupId":"FG001","numSubjects":"379"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"30"},{"groupId":"FG001","numSubjects":"17"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"12"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"5"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"The full analysis set (FAS) included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation","groups":[{"id":"BG000","title":"Semaglutide","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg."},{"id":"BG001","title":"Placebo","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"396"},{"groupId":"BG001","value":"396"},{"groupId":"BG002","value":"792"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"66.2","spread":"9.71"},{"groupId":"BG001","value":"67.0","spread":"8.96"},{"groupId":"BG002","value":"66.6","spread":"9.35"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"107"},{"groupId":"BG001","value":"88"},{"groupId":"BG002","value":"195"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"289"},{"groupId":"BG001","value":"308"},{"groupId":"BG002","value":"597"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"13"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"388"},{"groupId":"BG001","value":"385"},{"groupId":"BG002","value":"773"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"6"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"131"},{"groupId":"BG001","value":"109"},{"groupId":"BG002","value":"240"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"8"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"259"},{"groupId":"BG001","value":"279"},{"groupId":"BG002","value":"538"}]},{"title":"Other","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"4"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Maximum Walking Distance on a Constant Load Treadmill Test","description":"Change in maximum walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants continue on the treadmill after indicating onset of pain and should continue as long as possible until pain limits further activity. This distance is noted as the maximum walking distance. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.","populationDescription":"Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"Ratio of maximum walking distance","timeFrame":"Baseline (week 0), end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"338"},{"groupId":"OG001","value":"345"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.21","lowerLimit":"0.95","upperLimit":"1.55"},{"groupId":"OG001","value":"1.08","lowerLimit":"0.86","upperLimit":"1.36"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0004","statisticalMethod":"Wilcoxon (Mann-Whitney)","paramType":"The Hodges-Lehmann estimate","paramValue":"1.13","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.056","ciUpperLimit":"1.211"}]},{"type":"SECONDARY","title":"Follow-up Change in Maximum Walking Distance on a Constant Load Treadmill Test","description":"Change in maximum walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants continue on the treadmill after indicating onset of pain and should continue as long as possible until pain limits further activity. This distance is noted as the maximum walking distance. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, which-ever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.","populationDescription":"Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"Ratio of maximum walking distance","timeFrame":"Baseline (week 0), end of follow-up (week 57)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"329"},{"groupId":"OG001","value":"333"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.16","lowerLimit":"0.92","upperLimit":"1.48"},{"groupId":"OG001","value":"1.10","lowerLimit":"0.87","upperLimit":"1.40"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0380","statisticalMethod":"Wilcoxon (Mann-Whitney)","paramType":"The Hodges-Lehmann estimate","paramValue":"1.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.004","ciUpperLimit":"1.156"}]},{"type":"SECONDARY","title":"Change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) Score","description":"Change in VascuQoL-6 score is presented. VascuQoL-6 is a peripheral artery disease-specific questionnaire with 6 items covering social, emotional, functional as well as pain- and symptom-related aspects of the patient´s overall quality of life. Each item has a 4-point response scale (where 1 = worst score and 4 = best score). The endpoint analysed is the total score (range: 6-24) generated by summing the scores from all items. A higher score indicates better health status. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.","populationDescription":"Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"Scores on a scale","timeFrame":"Baseline (week 0), end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"362"},{"groupId":"OG001","value":"362"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.0","lowerLimit":"0.00","upperLimit":"4.00"},{"groupId":"OG001","value":"1.0","lowerLimit":"-1.00","upperLimit":"4.00"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0108","statisticalMethod":"Wilcoxon (Mann-Whitney)","paramType":"The Hodges-Lehmann estimate","paramValue":"1.00","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.478","ciUpperLimit":"1.518"}]},{"type":"SECONDARY","title":"Change in Pain-free Walking Distance on a Constant Load Treadmill Test","description":"Change in pain-free walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants are instructed to when pain starts in either leg and to continue on the treadmill without stopping at this stage. The distance walked is noted as the pain-free walking distance. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.","populationDescription":"Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"Ratio of pain-free walking distance","timeFrame":"Baseline (week 0), end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"338"},{"groupId":"OG001","value":"344"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.21","lowerLimit":"0.92","upperLimit":"1.52"},{"groupId":"OG001","value":"1.10","lowerLimit":"0.86","upperLimit":"1.44"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0046","statisticalMethod":"Wilcoxon (Mann-Whitney)","paramType":"The Hodges-Lehmann Estimate","paramValue":"1.11","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.033","ciUpperLimit":"1.197"}]},{"type":"SECONDARY","title":"Follow-up Change in Pain-free Walking Distance on a Constant Load Treadmill Test","description":"Change in pain-free walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants are instructed to when pain starts in either leg and to continue on the treadmill without stop-ping at this stage. The distance walked is noted as the pain-free walking distance. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.","populationDescription":"Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"Ratio of pain-free walking distance","timeFrame":"Baseline (week 0), end of follow-up (week 57)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"329"},{"groupId":"OG001","value":"333"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.18","lowerLimit":"0.92","upperLimit":"1.59"},{"groupId":"OG001","value":"1.10","lowerLimit":"0.83","upperLimit":"1.48"}]}]}]},{"type":"SECONDARY","title":"Change in Glycosylated Haemoglobin (HbA1c)","description":"Change in HbA1c from baseline to week 52 in percentage-point is presented. The outcome measure is evaluated based on the on treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).","populationDescription":"Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage-point of HbA1c","timeFrame":"Baseline (week 0), end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"304"},{"groupId":"OG001","value":"311"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.8","spread":"1.1"},{"groupId":"OG001","value":"0.2","spread":"1.1"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight","description":"Change in body weight from baseline to week 52 in kilogram (kg) is presented. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).","populationDescription":"Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilogram (kg)","timeFrame":"Baseline (week 0), end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"310"},{"groupId":"OG001","value":"318"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5.2","spread":"4.8"},{"groupId":"OG001","value":"-1.2","spread":"4.2"}]}]}]},{"type":"SECONDARY","title":"Change in Systolic Blood Pressure","description":"Change in systolic blood pressure from baseline to week 52 is presented.The outcome measure is evaluated based on the on treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).","populationDescription":"Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimetre of mercury (mmHg)","timeFrame":"Baseline (week 0), end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"310"},{"groupId":"OG001","value":"319"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4","spread":"15"},{"groupId":"OG001","value":"-1","spread":"18"}]}]}]},{"type":"SECONDARY","title":"Change in Total Cholesterol","description":"Change in total cholesterol from baseline to week 52 is presented as ratio to baseline. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).","populationDescription":"Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of total cholesterol","timeFrame":"Baseline (week 0), end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"305"},{"groupId":"OG001","value":"312"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.96","spread":"20.18"},{"groupId":"OG001","value":"1.00","spread":"19.88"}]}]}]},{"type":"SECONDARY","title":"Change in Low-density Lipoprotein (LDL)-Cholesterol","description":"Change in LDL-cholesterol from baseline to week 52 is presented as ratio to baseline. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).","populationDescription":"Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of LDL","timeFrame":"Baseline (week 0), end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"294"},{"groupId":"OG001","value":"296"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"38.37"},{"groupId":"OG001","value":"1.03","spread":"42.27"}]}]}]},{"type":"SECONDARY","title":"Change in High Density Lipoprotein (HDL)-Cholesterol","description":"Change in HDL-cholesterol from baseline to week 52 is presented as ratio to baseline. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).","populationDescription":"Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of HDL","timeFrame":"Baseline (week 0), end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"294"},{"groupId":"OG001","value":"295"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.04","spread":"15.95"},{"groupId":"OG001","value":"0.99","spread":"13.91"}]}]}]},{"type":"SECONDARY","title":"Change in Triglycerides","description":"Change in Triglycerides from baseline to week 52 is presented as ratio to baseline. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).","populationDescription":"Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of triglycerides","timeFrame":"Baseline (week 0), end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"305"},{"groupId":"OG001","value":"310"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.80","spread":"45.95"},{"groupId":"OG001","value":"0.95","spread":"41.73"}]}]}]},{"type":"SECONDARY","title":"Change in Ankle-Brachial Index (ABI)","description":"Change in ABI from baseline to week 52 is presented. ABI is calculated as a ratio of the higher ankle systolic pressure to the higher systolic pressure measured in both arms. ABI is measured at both left and right leg and the analysis endpoint is defined as the lower of the two indices. An ABI between 1.0 to 1.4 is considered the normal range. An ABI between 0.90 to 0.99 is considered borderline. An ABI less than 0.90 indicates peripheral artery disease (PAD). The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).","populationDescription":"Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of ABI","timeFrame":"Screening (week -2), end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"306"},{"groupId":"OG001","value":"315"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.06","spread":"34.0"},{"groupId":"OG001","value":"1.02","spread":"19.6"}]}]}]},{"type":"SECONDARY","title":"Change in Toe-Brachial Index (TBI)","description":"Change in TBI from baseline to week 52 is presented. TBI is calculated as a ratio of the toe systolic pressure to the higher systolic pressure measured in both arms. TBI is measured at both left and right leg and the analysis endpoint is defined as the lower of the two indices. A TBI range of above or equal to 0.7 is considered normal, whereas a TBI less than 0.7 is considered abnormal. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).","populationDescription":"Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of TBI","timeFrame":"Screening (week -2), end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"297"},{"groupId":"OG001","value":"301"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.07","spread":"34.4"},{"groupId":"OG001","value":"1.04","spread":"37.3"}]}]}]},{"type":"SECONDARY","title":"Change in Walking Impairment Questionnaire (WIQ) Global Score","description":"Change in WIQ global score from baseline to week 52 is presented. WIQ consists of three domains, speed, distance, and stair climbing, consisting of in total 14 questions. Each response is weighted based on the difficulty of the task. Domain scores are determined by dividing the weighted answers by the maximum possible weighted score and multiplying by 100. Global score is calculated as the mean of the three domain scores (ranged from 0% to 100%). A global score of 0% represents inabil-ity to perform any of the tasks and 100% represents no difficulty with any of the tasks. Higher scores indicate better walking ability and less impairment. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).","populationDescription":"Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"%-point scores on a scale","timeFrame":"Baseline (week 0), end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"312"},{"groupId":"OG001","value":"321"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9.48","spread":"18.63"},{"groupId":"OG001","value":"6.51","spread":"20.53"}]}]}]},{"type":"SECONDARY","title":"Change in Short Form 36 (SF-36) Physical Functioning Domain","description":"Change in SF-36 physical functioning domain from baseline to week 52 is presented. SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2 (acute version) questionnaire measured 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). The 0-100 scale scores from the SF-36 were converted to norm-based scores (Range: 19.03 to 57.60) to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A positive change score indicates an improvement in participant health stats. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).","populationDescription":"Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Scores on a scale","timeFrame":"Baseline (week 0), end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"311"},{"groupId":"OG001","value":"320"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.98","spread":"7.32"},{"groupId":"OG001","value":"1.52","spread":"7.17"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Until week 57","description":"All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.","eventGroups":[{"id":"EG000","title":"Semaglutide","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.","deathsNumAffected":4,"deathsNumAtRisk":396,"seriousNumAffected":74,"seriousNumAtRisk":396,"otherNumAffected":47,"otherNumAtRisk":396},{"id":"EG001","title":"Placebo","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.","deathsNumAffected":9,"deathsNumAtRisk":395,"seriousNumAffected":78,"seriousNumAtRisk":395,"otherNumAffected":24,"otherNumAtRisk":395}],"seriousEvents":[{"term":"Abdominal abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":396},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":395}]},{"term":"Abdominal symptom","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":396},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":395}]},{"term":"Abscess limb","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":396},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":395}]},{"term":"Accelerated hypertension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":396},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":395}]},{"term":"Acute coronary syndrome","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":396},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":395}]},{"term":"Acute kidney injury","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 27","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":396},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":395}]},{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":3,"numAtRisk":396},{"groupId":"EG001","numEvents":5,"numAffected":5,"numAtRisk":395}]},{"term":"Acute respiratory failure","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":396},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":395}]},{"term":"Adenocarcinoma of colon","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 27","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":396},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":395}]},{"term":"Alkalosis","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 27","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":396},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":395}]},{"term":"Anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 27","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":396},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":395}]},{"term":"Anal abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":396},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":395}]},{"term":"Angina pectoris","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":396},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":395}]},{"term":"Angina unstable","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":396},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":395}]},{"term":"Ankle fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":396},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":395}]},{"term":"Appendicitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":396},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":395}]},{"term":"Arteriosclerosis","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 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