18 and older, any sex, with Diabetes Mellitus, Type 2 or Peripheral Arterial Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Maximum Walking Distance on a Constant Load Treadmill TestPrimary· Baseline (week 0), end of treatment (week 52)
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
Group
Value
95% CI
Semaglutide
1.21
0.95 – 1.55
Placebo
1.08
0.86 – 1.36
Follow-up Change in Maximum Walking Distance on a Constant Load Treadmill TestSecondary· Baseline (week 0), end of follow-up (week 57)
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
Group
Value
95% CI
Semaglutide
1.16
0.92 – 1.48
Placebo
1.10
0.87 – 1.40
Change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) ScoreSecondary· Baseline (week 0), end of treatment (week 52)
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 a
Group
Value
95% CI
Semaglutide
2.0
0.00 – 4.00
Placebo
1.0
-1.00 – 4.00
Change in Pain-free Walking Distance on a Constant Load Treadmill TestSecondary· Baseline (week 0), end of treatment (week 52)
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 perio
Group
Value
95% CI
Semaglutide
1.21
0.92 – 1.52
Placebo
1.10
0.86 – 1.44
Follow-up Change in Pain-free Walking Distance on a Constant Load Treadmill TestSecondary· Baseline (week 0), end of follow-up (week 57)
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 peri
Group
Value
95% CI
Semaglutide
1.18
0.92 – 1.59
Placebo
1.10
0.83 – 1.48
Change in Glycosylated Haemoglobin (HbA1c)Secondary· Baseline (week 0), end of treatment (week 52)
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).
Group
Value
95% CI
Semaglutide
-0.8
± 1.1
Placebo
0.2
± 1.1
Change in Body WeightSecondary· Baseline (week 0), end of treatment (week 52)
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).
Group
Value
95% CI
Semaglutide
-5.2
± 4.8
Placebo
-1.2
± 4.2
Change in Systolic Blood PressureSecondary· Baseline (week 0), end of treatment (week 52)
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).
Group
Value
95% CI
Semaglutide
-4
± 15
Placebo
-1
± 18
Change in Total CholesterolSecondary· Baseline (week 0), end of treatment (week 52)
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).
Group
Value
95% CI
Semaglutide
0.96
± 20.18
Placebo
1.00
± 19.88
Change in Low-density Lipoprotein (LDL)-CholesterolSecondary· Baseline (week 0), end of treatment (week 52)
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).
Group
Value
95% CI
Semaglutide
0.99
± 38.37
Placebo
1.03
± 42.27
Change in High Density Lipoprotein (HDL)-CholesterolSecondary· Baseline (week 0), end of treatment (week 52)
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).
Group
Value
95% CI
Semaglutide
1.04
± 15.95
Placebo
0.99
± 13.91
Change in TriglyceridesSecondary· Baseline (week 0), end of treatment (week 52)
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).
Group
Value
95% CI
Semaglutide
0.80
± 45.95
Placebo
0.95
± 41.73
Adverse events — posted to ClinicalTrials.gov
Time frame: Until week 57.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07430332 — GLP-1 RA for Stage 1 Type 1 Diabetes
· Phase 2
· not yet recruiting
NCT06977438 — Promoting Healthy Children and Youth
· Phase 4
· not yet recruiting
NCT07218354 — Cessation or Reduction of Alcohol Consumption in Veterans: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial
· Phase 3
· not yet recruiting
NCT07511543 — Glucagon-like Peptide-1 Receptor Agonists for Endovascular Stroke Thrombectomy
· Phase 2
· not yet recruiting
NCT07570810 — Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obesity and T2DM
· NA
· not yet recruiting
Other recruiting trials for Diabetes Mellitus, Type 2
Currently open trials in the same condition.
NCT07415954 — A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2
· Phase 2
· recruiting
NCT07532863 — A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Part
· recruiting
NCT07336329 — Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use
· NA
· recruiting
NCT07242469 — A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006)
· Phase 1
· recruiting
NCT07444203 — Transformative Research in Diabetic Nephropathy 2.0
· recruiting
Other Novo Nordisk A/S trials
Trials by the same sponsor.
NCT07357740 — A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes
· Phase 2
· not yet recruiting
NCT07282613 — A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adoles
· Phase 3
· not yet recruiting
NCT07357766 — A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight
· Phase 3
· not yet recruiting
NCT07564414 — A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obe
· Phase 3
· not yet recruiting
NCT07400107 — AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Exc
· Phase 3
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novo Nordisk A/S
Last refreshed: 12 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04560998.