Washington, D.C.; December 15th, 2025.
Two large Phase 3 clinical trials evaluating a GLP-1 receptor agonist for the treatment of early Alzheimer’s disease did not demonstrate a statistically significant slowing of cognitive decline, according to results disclosed by NOVO NORDISK and posted in official trial records maintained by CLINICALTRIALS.GOV.
The trials, known as EVOKE and EVOKE Plus, evaluated semaglutide in patients with mild cognitive impairment or mild Alzheimer’s disease. According to data submitted by NOVO NORDISK to CLINICALTRIALS.GOV, neither study met its primary endpoint of slowing cognitive or functional decline compared to placebo over the treatment period.
In its official disclosure, NOVO NORDISK stated that while semaglutide has demonstrated benefits in metabolic and cardiovascular conditions, the EVOKE program did not show evidence of clinical benefit for Alzheimer’s disease. The company reported that safety findings in the trials were generally consistent with the known safety profile of semaglutide observed in other approved indications.
Records posted by CLINICALTRIALS.GOV show that both trials were randomized, double-blind, and placebo-controlled, involving thousands of participants across multiple countries. Cognitive outcomes were measured using established clinical assessment tools commonly employed in Alzheimer’s research. According to the posted results, differences between the treatment and placebo groups did not reach statistical significance.
Regulatory filings from THE U.S. FOOD AND DRUG ADMINISTRATION confirm that GLP-1 receptor agonists, including semaglutide, are currently approved for indications related to diabetes and weight management, and do not carry approval for the treatment or prevention of Alzheimer’s disease.
The EVOKE trial results were also presented through official scientific channels, including sponsor-submitted materials associated with major international neurology and Alzheimer’s research conferences, where NOVO NORDISK reported that the findings did not support advancing semaglutide as a disease-modifying therapy for Alzheimer’s.
The results add to a growing body of research exploring whether metabolic and anti-inflammatory pathways can influence neurodegenerative disease progression. While earlier observational studies and smaller trials had suggested potential neurological benefits, the Phase 3 data reported by NOVO NORDISK indicate that semaglutide did not produce measurable cognitive benefit in patients with early Alzheimer’s disease under rigorous trial conditions.
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Sources
Primary First-Hand Sources
• CLINICALTRIALS.GOV, EVOKE and EVOKE Plus Phase 3 trial records and posted results
• NOVO NORDISK, official trial results disclosure for the EVOKE program
• THE U.S. FOOD AND DRUG ADMINISTRATION, regulatory labeling and approval status for semaglutide

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