On 24 November, Novo Nordisk announced topline results from two Phase 3 clinical trials of semaglutide in early Alzheimer’s disease (AD), stating that while semaglutide treatment improved AD-related biomarkers in both studies, this did not translate into a delay in disease progression.
Evoke and Evoke+ are large-scale, randomised and placebo-controlled clinical trials investigating the safety, efficacy and tolerability of once-daily oral semaglutide in early-stage symptomatic Alzheimer’s disease. Semaglutide is classified as a GLP-1 receptor agonist, which mimics the action of GLP-1 to promote insulin synthesis and reduce blood glucose. The drug is available as an injectable medication or oral pill, and is widely used to treat type 2 diabetes and obesity. The Evoke trials enrolled a total of 3,808 people aged 55–85 years with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease with confirmed amyloid positivity. Trial participants received semaglutide or placebo for 156 weeks in total, with a 104-week main treatment phase and 52-week extension period.
According to a press release issued by the company, based on data from the two-year main treatment phase, semaglutide appeared to have a safe and well-tolerated profile, which is consistent with previous trials in other disease areas. In addition, treatment with semaglutide resulted in improvement of AD-related biomarkers. However, the trials did not confirm superiority of semaglutide over placebo as measured by change in the CDR-SB (Clinical Dementia Rating – Sum of Boxes) scale, a global measure of cognition and function in AD. Based on these results, the 1-year extension period in Evoke and Evoke+ will be discontinued.
Topline results from the trials will be presented at the upcoming Clinical Trials in Alzheimer’s Disease (CTAD) conference, which will take place between 1-4 December.
Read the full press release: https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916462