Ozempic® (semaglutide) injection 1 mg showed improved functional outcomes and health-related quality of life in Phase 3 STRIDE trial in adults with type 2 diabetes and peripheral artery disease (P...
- Semaglutide 1 mg demonstrated statistically significant and superior improvement in maximum walking distance by 13% over placebo in adults with type 2 diabetes and symptomatic PAD1
- Based on STRIDE trial data, presented at the American College of Cardiology's (ACC) Annual Scientific Session and Expo while simultaneously published today in The Lancet, Novo Nordisk submitted a label extension application accepted for review by the FDA
- Approximately 12 million people in the United States are impacted by PAD, a form of atherosclerotic disease, and one in four also have type 2 diabetes2,3
PLAINSBORO, N.J., March 29, 2025 /PRNewswire/ -- Novo Nordisk today presented results from STRIDE, its phase 3b trial investigating the effects of once-weekly Ozempic® (semaglutide) injection 1 mg in adults with type 2 diabetes and early-stage symptomatic PAD1, at the American College of Cardiology's (ACC) Annual Scientific Session and Expo. The results were presented during a late-breaking clinical trial session and highlighted at an official ACC press conference. In addition, the analysis was also simultaneously published today in The Lancet.
The double-blind, randomized, placebo-controlled STRIDE trial, which enrolled 792 adults with type 2 diabetes and symptomatic PAD, achieved its primary endpoint, with semaglutide 1 mg demonstrating a 13% superior improvement in maximum walking distance (estimated treatment ratio [ETR] vs placebo, 1.13; 95% confidence interval [CI], 1.06 to 1.21; p=0.0004) and a clinically meaningful median treatment difference of 26.4 meters (95% CI, 11.8 to 40.9; approximately 87 feet, or about a third the length of an American football field) on a 12% incline, compared to placebo at 52 weeks. The trial also demonstrated superiority to placebo for all confirmatory secondary outcomes assessed, including pain-free walking distance (ETR vs placebo 1.11; 95% CI, 1.03 to 1.20; p=0.0046) and Vascular Quality of Life Questionnaire-6 (VascuQoL-6) (estimated treatment difference vs placebo 1.00; 95% CI, 0.48 to 1.52; p=0.011) at 52 weeks.1,4
"Peripheral artery disease (PAD) may cause severe symptoms, physical limitations, and a diminished quality of life, often making even short walks—such as retrieving the mail—challenging. In individuals with PAD and diabetes, the disease can be even more severe, affecting small blood vessels and limiting the effectiveness of revascularization procedures and other treatments. Semaglutide 1 mg is the first medication in over two decades to show meaningful improvements in functional capacity and quality of life, which could address a critical unmet need for those with both PAD and type 2 diabetes," said Marc P. Bonaca, MD, Director of Vascular Research, University of Colorado School of Medicine, Lead Investigator of the STRIDE trial. "The significant improvements in walking distance and patient-reported quality of life observed with semaglutide 1 mg in the STRIDE trial are promising and represent an important step forward on the path to advancing treatment options for this patient population."
PAD is a form of atherosclerotic cardiovascular disease that is under screened, under diagnosed, and is associated with limited walking ability and poor health-related quality of life (QoL).2,3 Approximately 12 million people in the United States are impacted by PAD, and one in four also have type 2 diabetes.2,3 The presence of type 2 diabetes increases the incidence of PAD and accelerates disease progression and severity.3 There are limited therapies to specifically improve functional outcomes in people living with PAD and type 2 diabetes, representing a critical need.2
"The results from STRIDE, the first and only dedicated PAD functional outcomes trial with a GLP-1 RA treatment, provide important clinical insights that help further our understanding and approach to cardiometabolic diseases like type 2 diabetes and peripheral artery disease," said Michael Radin, MD, Executive Medical Director, Diabetes Medical Affairs at Novo Nordisk, Inc. "By studying the potential of semaglutide to impact everyday living through improvements in walking and quality of life, Novo Nordisk continues to demonstrate its commitment to advancing cardiometabolic science and to improving clinical outcomes for patients."
Serious adverse events (SAEs) were reported in 74 (19%) participants in the semaglutide arm and 78 (20%) participants in the placebo arm, and SAEs that were possibly/probably treatment-related occurred in 5 (1%) and 6 (2%) participants, respectively. The most frequent SAE across both groups was serious gastrointestinal events (2 [1%] vs 3 [1%]). SAEs leading to permanent treatment discontinuation of semaglutide or placebo were reported in 11 (2.8%) and 13 (3.3%) participants in the semaglutide and placebo groups, respectively. SAEs led to the death of 3 (1%) and 8 (2%) participants in the semaglutide and placebo arms, respectively; however, no SAEs leading to death were treatment-related.1,4
Based on data from the STRIDE clinical trial, Novo Nordisk submitted a label extension application for Ozempic® to the US Food & Drug Administration (FDA). A decision is anticipated in 2025.4
About STRIDE
STRIDE is a double-blind, randomized, placebo-controlled phase 3b clinical trial assessing the effect of once-weekly injectable semaglutide 1 mg, marketed as Ozempic®, on functional capacity versus placebo, when both were added to standard of care. It enrolled 792 adults with type 2 diabetes and symptomatic peripheral artery disease (PAD) with walking-induced leg pain. The primary endpoint was maximum walking distance on a constant load treadmill for people treated with semaglutide compared to placebo at week 52. STRIDE is the only dedicated PAD functional outcomes trial with a glucagon-like peptide-1 (GLP-1) receptor agonist.4
About PAD
Lower extremity peripheral artery disease (PAD) is a form of atherosclerotic cardiovascular disease. The classical symptom is intermittent claudication (IC), associated with limited walking ability and poor health-related quality of life (QoL).2,5 Approximately 12 million people in the United States are impacted by PAD, and one in four also have type 2 diabetes.2,3 There are limited therapies to specifically improve functional outcomes in people living with PAD and type 2 diabetes, representing a critical need.2
About Ozempic®
Ozempic® (semaglutide) injection 0.5 mg, 1 mg or 2 mg is a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve blood sugar (glucose), along with diet and exercise, in adults with type 2 diabetes, to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes with known heart disease, and to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease.6
Only Novo Nordisk manufactures FDA-approved semaglutide medicines, like Ozempic®. Given the vast amount of information on knock-off or compounded semaglutide being shared in the media, it is important for healthcare professionals and patients to have the clarity and confidence in knowing what they are using has undergone rigorous review for safety, effectiveness and quality. If the label doesn't say Ozempic®, it's not FDA-approved. Learn more about the responsible use of semaglutide-containing medicines and the significant safety and health risks associated with compounded or knock-off "semaglutide" at semaglutide.com.
About Novo Nordisk
Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With U.S. headquarters in New Jersey and over ten manufacturing, R&D and business locations in eight states plus Washington DC, Novo Nordisk employs approximately 10,000 people throughout the country. For more information, visit novonordisk-us.com, Facebook, Instagram, and X.
Contacts for further information:
Media: | |
Liz Skrbkova (US) | Ambre James-Brown (Global) |
| |
Investors: | |
Frederik Taylor Pitter (US) | Jacob Martin Wiborg Rode |
|
|
| |
References
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2025 Novo Nordisk All rights reserved. US25OZM00368 March 2025
View original content:SOURCE Novo Nordisk, Inc.