Novo Nordisk disclosed that its late‑stage oral semaglutide studies, Evoke and Evoke+, did not achieve the primary goal of slowing cognitive decline in patients with early Alzheimer’s disease. The two trials enrolled 3,808 adults and, while showing modest improvements in Alzheimer‑related biomarkers, the changes did not translate into a statistically significant reduction in disease progression.
The Evoke and Evoke+ programs were designed to evaluate the efficacy of oral semaglutide, the same formulation used in the diabetes drug Rybelsus, in a population of patients with mild cognitive impairment or early Alzheimer’s. The trials were powered to detect a 20‑percent slowing of the Alzheimer’s Disease Assessment Scale‑Cognitive Subscale (ADAS‑Cog) over 18 months. Although biomarker data—including reductions in amyloid‑β and tau levels—were encouraging, the clinical endpoint was missed by a margin of 0.3 points on the ADAS‑Cog, falling short of the pre‑specified threshold.
The failure of these studies removes a potential high‑growth avenue for Novo Nordisk’s GLP‑1 portfolio. Analysts had viewed the Alzheimer’s indication as a “lottery ticket” that could have diversified the company’s revenue base beyond diabetes and obesity. The setback has intensified concerns about the firm’s ability to sustain growth in a market where competitors such as Eli Lilly are aggressively expanding their own GLP‑1 offerings. The company’s stock fell sharply in the days following the announcement, reflecting investor anxiety about the loss of a future growth catalyst.
Novo Nordisk’s chief scientific officer, Martin Holst Lange, said the company pursued the Alzheimer’s indication because of the significant unmet need and the encouraging signals from real‑world evidence, pre‑clinical models, and post‑hoc analyses of its diabetes and obesity trials. He acknowledged a “low likelihood of success” and described the trials as a “lottery ticket.” He added that the extensive evidence supporting semaglutide’s benefits for type 2 diabetes and obesity remains intact and will continue to drive the company’s core business.
Market reaction was driven by the definitive miss of the primary endpoint and the decision to discontinue the planned one‑year extension of the studies. Analysts noted that the loss of a potential growth catalyst, combined with mounting competitive pressure in the weight‑loss drug market, prompted a reassessment of Novo Nordisk’s long‑term growth prospects. The company will present full results at the Clinical Trials on Alzheimer’s Disease (CTAD) conference on December 3, 2025, where it hopes to provide a more detailed explanation of the biomarker findings and the reasons for the clinical failure.
Looking ahead, Novo Nordisk will focus on its core GLP‑1 products while exploring other therapeutic areas. The company’s decision to halt the extension phase signals a shift in resource allocation toward more promising candidates. Investors will watch for updates on the company’s pipeline diversification strategy and any new indications that could offset the loss of the Alzheimer’s program.
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