Novo Nordisk’s GLP-1 drug semaglutide did not demonstrate a statistically significant effect in slowing progression of Alzheimer’s disease in two late-stage clinical trials.
According to a Nov. 24 news release from the company, two double-blinded, placebo-controlled phase 3 trials enrolled 3,808 adults ages 55-85 with mild cognitive impairment or mild dementia. Over a two-year period, semaglutide failed to show superiority over placebo in reducing the rate of decline on the Clinical Dementia Rating Sum of Boxes score. Novo Nordisk said the trials will be discontinued early.
While semaglutide improved Alzheimer’s-related biomarkers, those improvements did not translate into clinical benefit. Novo Nordisk said the drug’s safety profile was consistent with prior studies, citing more than 37 million patient-years of semaglutide exposure.
The results mirror a finding from February, when a phase 3 trial of another GLP-1 drug, exenatide, failed to slow Parkinson’s disease progression in a 96-week study. Combined with the most recent study, the findings cast doubt on the use of GLP-1s in treating neurodegenerative diseases.