Novo Nordisk A/S NVO on Saturday introduced the total outcomes from the Part 3b STRIDE peripheral artery illness (PAD) outcomes trial.
The examine evaluated the once-weekly injectable Ozempic (semaglutide 1.0 mg) in adults with kind 2 diabetes and PAD, on the American Faculty of Cardiology’s (ACC) Annual Scientific Session and Expo.
The trial achieved its major endpoint, with semaglutide 1.0 mg demonstrating a superior and clinically significant enchancment of 13% in most strolling distance and a imply remedy distinction of 39.9 meters on a steep incline, in comparison with placebo at week 52.
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The trial additionally demonstrated superiority to placebo for all confirmatory secondary outcomes assessed, together with pain-free strolling distance at week 52, health-related high quality of life at week 52, and most strolling distance at week 571.
The protection outcomes from the STRIDE trial are in step with the well-established security and tolerability profile of once-weekly semaglutide, supported by long-term security information with greater than 33 million affected person years of publicity.
Novo Nordisk submitted a label extension utility for Ozempic to the European Medicines Company (EMA) and the US Meals and Drug Administration (FDA). A call is anticipated in 2025.
Novo Nordisk additionally presented the total outcomes from the SOUL cardiovascular outcomes trial, demonstrating that Rybelsus (oral semaglutide) considerably decreased the danger of main hostile cardiovascular occasions in adults with kind 2 diabetes and heart problems (CVD) and/or persistent kidney illness (CKD).
The SOUL trial achieved its major endpoint, demonstrating a 14% discount in threat of main hostile cardiovascular occasions (MACE) in adults with kind 2 diabetes and CVD and/or CKD when handled with Rybelsus in comparison with placebo.
Every part of MACE, CV dying, nonfatal myocardial infarction, and nonfatal stroke contributed to the danger discount.
The general security profile of oral semaglutide in SOUL was in step with that seen in earlier semaglutide trials, and no new security alerts had been noticed.
In a key secondary evaluation from SOUL revealed concurrently, oral semaglutide decreased the danger of MACE independently of baseline use of SGLT2i and suggests comparable advantages in individuals with and with out concomitant SGLT2i use throughout the trial.
Novo Nordisk submitted a label extension utility for Rybelsus, which has been accepted for overview by the EMA and the FDA. A call is anticipated in 2025.
Worth Motion: Novo Nordisk inventory is down 2.06% at $67.87 throughout the premarket session on the final examine Monday.
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