{"id":157176,"date":"2025-11-24T14:55:10","date_gmt":"2025-11-24T14:55:10","guid":{"rendered":"https:\/\/www.newsbeep.com\/ie\/157176\/"},"modified":"2025-11-24T14:55:10","modified_gmt":"2025-11-24T14:55:10","slug":"evoke-phase-3-trials-did-not-demonstrate","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/ie\/157176\/","title":{"rendered":"Evoke phase 3 trials did not demonstrate"},"content":{"rendered":"

Bagsv\u00e6rd, Denmark, 24 November 2025\u00a0\u2013 Novo Nordisk today announced the top-line results from the 2-year primary analysis of evoke and evoke+ phase 3 trials in early-stage symptomatic Alzheimer\u2019s disease. The two trials were randomised, double-blinded, enrolled a total of 3808 adults and evaluated the efficacy and safety of oral semaglutide compared to placebo on top of standard of care. The decision to pursue an Alzheimer\u2019s disease indication with semaglutide was based on real-world evidence studies, pre-clinical models as well as post-hoc analyses from diabetes and obesity trials.<\/p>\n

The evoke and evoke+ trials did not confirm superiority of semaglutide versus placebo in the reduction of progression of Alzheimer\u2019s disease, as measured by the change in Clinical Dementia Rating \u2013 Sum of Boxes (CDR-SB) score compared to baseline. While treatment with semaglutide resulted in improvement of Alzheimer\u2019s disease-related biomarkers in both trials, this did not translate into a delay of disease progression.<\/p>\n

In the evoke trials with patients aged 55-85, suffering from mild cognitive impairment or mild dementia due to Alzheimer\u2019s disease, semaglutide appeared to have a safe and well-tolerated profile consistent with previous semaglutide trials. To date, more than 37 million patient-years of semaglutide exposure have occurred across diverse patient populations.<\/p>\n

\u201cBased on the significant unmet need in Alzheimer\u2019s disease as well as a number of indicative data points, we felt we had a responsibility to explore semaglutide\u2019s potential, despite a low likelihood of success. We are proud to have conducted two well-controlled phase 3 trials in Alzheimer\u2019s disease that meet the highest standards of research and rigorous methodology,\u201d said Martin Holst Lange, chief scientific officer and executive vice president of Research and Development at Novo Nordisk. \u201cWe sincerely thank all participants and their caregivers for their meaningful contributions. While semaglutide did not demonstrate efficacy in slowing the progression of Alzheimer\u2019s disease, the extensive body of evidence supporting semaglutide continues to provide benefits for individuals with type 2 diabetes, obesity, and related comorbidities.\u201d<\/p>\n

The 1-year extension period in the evoke and evoke+ trials will be discontinued based on the efficacy results observed in the overall study population. Topline results from the evoke\/evoke+ trials will be presented at the Clinical Trials in Alzheimer\u2019s Disease (CTAD) conference on 3 December 2025, and full results at the 2026 Alzheimer\u2019s and Parkinson\u2019s Diseases Conferences (AD\/PD) in March 2026.<\/p>\n

About Alzheimer\u2019s disease
Alzheimer’s disease is the most common cause of dementia, accounting for 60-80% of all dementia cases worldwide. Dementia is a general term for memory loss and other cognitive abilities serious enough to interfere with daily life. Alzheimer\u2019s disease is a progressive disease, where symptoms gradually worsen over time. Each stage of the disease presents different challenges for those living with the disease and their care partners. There is a significant unmet need for new treatment options that can slow down the progression of Alzheimer\u2019s disease and reduce the overall burden on people affected and on society.<\/p>\n

About Clinical Dementia Rating \u2013 Sum of Boxes
The\u00a0Clinical Dementia Rating scale (CDR) is a global measure of cognition and function obtained by interviewing both patient and care partner, commonly used staging tool for Alzheimer\u2019s disease in research settings. It measures six areas covering cognition and function, where each area is scored between 0 (no dementia) and 3 (severe dementia). The summary score of the six areas (maximum score of 18), referred to as sum of boxes (CDR-SB) has been applied to clinical trials in Alzheimer\u2019s disease to track progression and assess disease severity.\u00a0In the evoke and evoke+ trials, the change in CDR-SB for semaglutide compared to placebo was measured from baseline to week 104.<\/p>\n

About the evoke\/evoke+ studies
Evoke and evoke+ are large-scale trials investigating the disease-modifying potential of semaglutide in people with Alzheimer\u2019s disease. They are global, randomised, double-blind, placebo-controlled confirmatory phase 3 trials investigating the efficacy, safety, and tolerability of once-daily oral semaglutide 14 mg versus placebo in early-stage symptomatic Alzheimer\u2019s disease. The trials included men or women aged 55\u201385 years with MCI (defined as CDR global of 0.5) or mild dementia due to Alzheimer\u2019s disease (defined as CDR global score of 1.0) with confirmed amyloid positivity. In the evoke and evoke+ trials, 1,855 and 1,953 people respectively, were randomised 1:1 to semaglutide or placebo for 156 weeks (104-week main treatment phase and 52-week extension).<\/p>\n

About semaglutide
Semaglutide is a GLP-1 receptor agonist marketed under the brand names Ozempic\u00ae and Rybelsus\u00ae for the treatment of type 2 diabetes, and Wegovy\u00ae for the treatment of chronic weight management.<\/p>\n

About Novo Nordisk
Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 78,500 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, X, LinkedIn and YouTube.<\/p>\n

Publication of inside information pursuant to Market Abuse Regulation, Article 17.<\/p>\n

Contacts for further information<\/p>\n

Company announcement No 37 \/ 2025<\/p>\n

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