1NVO : Novo Nordisk Shares Data From Injectable Ozempic, Oral Weight Loss Drug

Novo Nordisk A/S NVO on Saturday presented the full results from the Phase 3b STRIDE peripheral artery disease (PAD) outcomes trial.

The study evaluated the once-weekly injectable Ozempic (semaglutide 1.0 mg) in adults with type 2 diabetes and PAD, at the American College of Cardiology’s (ACC) Annual Scientific Session and Expo.

The trial achieved its primary endpoint, with semaglutide 1.0 mg demonstrating a superior and clinically meaningful improvement of 13% in maximum walking distance and a mean treatment difference of 39.9 meters on a steep incline, compared to placebo at week 52.

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The trial also demonstrated superiority to placebo for all confirmatory secondary outcomes assessed, including pain-free walking distance at week 52, health-related quality of life at week 52, and maximum walking distance at week 571.

The safety results from the STRIDE trial are consistent with the well-established safety and tolerability profile of once-weekly semaglutide, supported by long-term safety data with more than 33 million patient years of exposure.

Novo Nordisk submitted a label extension application for Ozempic to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). A decision is anticipated in 2025.

Novo Nordisk also presented the full results from the SOUL cardiovascular outcomes trial, demonstrating that Rybelsus (oral semaglutide) significantly reduced the risk of major adverse cardiovascular events in adults with type 2 diabetes and cardiovascular disease (CVD) and/or chronic kidney disease (CKD).

The SOUL trial achieved its primary endpoint, demonstrating a 14% reduction in risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes and CVD and/or CKD when treated with Rybelsus compared to placebo.

Each component of MACE, CV death, nonfatal myocardial infarction, and nonfatal stroke contributed to the risk reduction.

The overall safety profile of oral semaglutide in SOUL was consistent with that seen in previous semaglutide trials, and no new safety signals were observed.

In a key secondary analysis from SOUL published simultaneously, oral semaglutide reduced the risk of MACE independently of baseline use of SGLT2i and suggests similar benefits in participants with and without concomitant SGLT2i use during the trial.

Novo Nordisk submitted a label extension application for Rybelsus, which has been accepted for review by the EMA and the FDA. A decision is anticipated in 2025.

Price Action: Novo Nordisk stock is down 2.06% at $67.87 during the premarket session at the last check Monday.

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