Trial results for semaglutide in people with peripheral arterial disease (PAD) and type 2 diabetes were posted on ClinicalTrials.gov on 2025-07-08. The study demonstrated that participants receiving semaglutide achieved a median ratio of maximum walking distance of 1.21, compared to 1.08 for those on placebo. The median change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) score was also higher for semaglutide at 2.0 versus 1.0 for placebo.
Background
Semaglutide is a medicine used for type 2 diabetes. This study investigated its effect on walking ability and other parameters in people also living with peripheral arterial disease (PAD).
Trial design
The study (NCT04560998) was a Phase 3, randomized, placebo-controlled trial that enrolled 792 participants. The study investigated semaglutide compared to placebo in people with peripheral arterial disease and type 2 diabetes. Participants received either semaglutide or placebo via weekly injection. The study aimed to see if semaglutide had an effect on walking ability compared with placebo.
Key results
The trial results showed improvements in walking distance, quality of life, and HbA1c for the semaglutide group compared to placebo.
For 'Change in Maximum Walking Distance on a Constant Load Treadmill Test':
- The median ratio for the semaglutide group was 1.21.
- The median ratio for the placebo group was 1.08.
An analysis using the Wilcoxon (Mann-Whitney) method showed a Hodges-Lehmann estimate of 1.13 (95.0% CI: 1.056 to 1.211) with a p-value of 0.0004.
For 'Follow-up Change in Maximum Walking Distance on a Constant Load Treadmill Test':
- The median ratio for the semaglutide group was 1.16.
- The median ratio for the placebo group was 1.10.
An analysis using the Wilcoxon (Mann-Whitney) method showed a Hodges-Lehmann estimate of 1.08 (95.0% CI: 1.004 to 1.156) with a p-value of 0.038.
For 'Change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) Score':
- The median score change for the semaglutide group was 2.0.
- The median score change for the placebo group was 1.0.
An analysis using the Wilcoxon (Mann-Whitney) method showed a Hodges-Lehmann estimate of 1.0 (95.0% CI: 0.478 to 1.518) with a p-value of 0.0108.
For 'Change in Pain-free Walking Distance on a Constant Load Treadmill Test':
- The median ratio for the semaglutide group was 1.21.
- The median ratio for the placebo group was 1.10.
An analysis using the Wilcoxon (Mann-Whitney) method showed a Hodges-Lehmann estimate of 1.11 (95.0% CI: 1.033 to 1.197) with a p-value of 0.0046.
For 'Follow-up Change in Pain-free Walking Distance on a Constant Load Treadmill Test':
- The median ratio for the semaglutide group was 1.18.
- The median ratio for the placebo group was 1.10.
For 'Change in Glycosylated Haemoglobin (HbA1c)':
- The mean change for the semaglutide group was -0.8 percentage-point (Standard Deviation: 1.1).
- The mean change for the placebo group was 0.2 percentage-point (Standard Deviation: 1.1).
What this means
The results indicate that semaglutide improved walking ability and quality of life in patients with peripheral arterial disease and type 2 diabetes. The statistically significant increases in maximum and pain-free walking distances, along with improved VascuQoL-6 scores, suggest a potential benefit for managing symptoms associated with PAD in this population. The observed reduction in HbA1c also reinforces semaglutide's known efficacy in glycemic control for type 2 diabetes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04560998, titled 'A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes,' were posted on 2025-07-08 on clinicaltrials.gov.