- Evoke phase 3 trials involved 3,808 adults over 2 years.
- Semaglutide did not significantly reduce Alzheimer's progression.
- 1-year extension of trials discontinued due to lack of efficacy.
- Results to be presented at CTAD conference on December 3, 2025.
Trial Overview
Novo Nordisk conducted the evoke and evoke+ phase 3 trials to assess the efficacy and safety of oral semaglutide in early-stage symptomatic Alzheimer's disease. The trials were randomized, double-blinded, and included 3,808 adults aged 55-85 with mild cognitive impairment or mild dementia due to Alzheimer's.
Results
The trials did not demonstrate a statistically significant reduction in Alzheimer's disease progression when comparing semaglutide to placebo, as measured by the Clinical Dementia Rating – Sum of Boxes (CDR-SB) score. Although semaglutide improved Alzheimer's-related biomarkers, it did not delay disease progression.
Safety and Tolerability
Semaglutide was found to have a safe and well-tolerated profile consistent with previous trials. Over 37 million patient-years of semaglutide exposure have been recorded across various populations.
Future Steps
Due to the lack of efficacy, the 1-year extension period of the trials will be discontinued. 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 (AD/PD) in March 2026.
