At the American College of Cardiology's (ACC) Annual Scientific Session and Expo, Novo Nordisk presented important findings from its Phase 3b STRIDE trial, which investigated the impact of a once-weekly 1 mg dose of Ozempic® (semaglutide) on adults with type 2 diabetes and early-stage symptomatic peripheral artery disease (PAD). This study is particularly significant given the growing recognition of the importance of improving walking ability in patients with PAD, a condition that is often associated with debilitating symptoms like intermittent claudication and reduced quality of life. The STRIDE trial aimed to assess not only the cardiovascular benefits of semaglutide but also its potential to improve functional outcomes such as walking distance in this specific patient population.

The STRIDE trial was a double-blind, randomized, placebo-controlled study that included 792 participants. The study met its primary endpoint, showing that semaglutide 1 mg resulted in a 13% greater improvement in maximum walking distance compared to placebo (estimated treatment ratio [ETR], 1.13; 95% confidence interval [CI], 1.06–1.21; p=0.0004). Participants receiving semaglutide showed a clinically relevant median treatment difference of 26.4 meters (95% CI, 11.8–40.9), roughly 87 feet or about a third of the length of a football field, on a 12% incline, after 52 weeks.

In terms of safety, serious adverse events (SAEs) were reported in 74 (19%) participants in the semaglutide group and 78 (20%) in the placebo group. Treatment-related SAEs were noted in 5 (1%) and 6 (2%) participants, respectively. The most common SAE in both groups was gastrointestinal issues (2 [1%] vs. 3 [1%]). SAEs leading to permanent treatment discontinuation occurred in 11 (2.8%) participants in the semaglutide group and 13 (3.3%) in the placebo group. There were 3 (1%) deaths in the semaglutide group and 8 (2%) in the placebo group, though none of these deaths were related to the treatment.

Here is a brief overview of the study:

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

Study Details | Source

  • Sponsor: Novo Nordisk A/S
  • 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.
  • Interventions:
    • Drug: Semaglutide
    • Drug: Placebo (semaglutide)
  • Primary Outcome Measures
    • Change in maximum walking distance on a constant load treadmill test
    • Ratio to baseline
      • Time frame - From baseline (week 0) to end of treatment (week 52)

In light of the STRIDE trial results, Novo Nordisk has submitted a label extension application for Ozempic to the U.S. Food and Drug Administration (FDA), with a decision expected in 2025.

We highly value your input and welcome any thoughts or insights you may have on this topic. Additionally, we encourage you to sign up for alerts to stay informed on the latest published guidelines and articles. Thank you for your continued support and engagement in advancing medical research and treatment options.

Copyright © 2025 Guideline Central, all rights reserved.