Novo Nordisk A/S: Evoke phase 3 trials did not demonstrate a statistically significant reduction in Alzheimer's disease progression

Core Insights - Novo Nordisk announced top-line results from the phase 3 evoke and evoke+ trials for oral semaglutide in early-stage symptomatic Alzheimer's disease, involving 3,808 adults [1][2] - The trials did not show superiority of semaglutide over placebo in slowing Alzheimer's disease progression, despite improvements in biomarkers [2][4] - The decision to explore semaglutide for Alzheimer's was based on real-world evidence and previous studies, although the likelihood of success was considered low [4] Study Details - The evoke and evoke+ trials were randomized, double-blind, and placebo-controlled, focusing on patients aged 55-85 with mild cognitive impairment or mild dementia due to Alzheimer's [3][7] - Semaglutide was administered at a dose of 14 mg once daily, with a total of 1,855 and 1,953 participants randomized in the two trials respectively [7] - The primary measure of efficacy was the change in Clinical Dementia Rating – Sum of Boxes (CDR-SB) score from baseline to week 104 [6][7] Safety and Tolerability - Semaglutide demonstrated a safe and well-tolerated profile consistent with previous trials, with over 37 million patient-years of exposure across various populations [3][4] - The one-year extension period of the trials will be discontinued due to the lack of efficacy observed [4] Future Presentations - Topline results will be presented at the Clinical Trials in Alzheimer's Disease (CTAD) conference on December 3, 2025, with full results to follow at the 2026 Alzheimer's and Parkinson's Diseases Conferences in March 2026 [4]