Novo Nordisk has announced the decision to enter phase 3 development in Alzheimer’s disease with 14 mg oral semaglutide, a once-daily oral formulation of the long-acting GLP-1 analogue semaglutide.
The decision follows evaluation of GLP-1 data from preclinical models, real-world evidence studies, post-hoc analysis of data from large cardiovascular outcomes trials, as well as discussions with regulatory authorities.
Initiation in the first half of 2021
Novo Nordisk intends to initiate a phase 3a programme with approximately 3,700 people with early Alzheimer’s disease. The programme is planned for initiation in the first half of 2021 and will investigate the efficacy and safety of once-daily oral semaglutide, compared to placebo. The expected main treatment period in the trials is around two years.
“As a company we aspire to address high unmet medical needs within serious chronic diseases, and we are therefore pleased to initiate phase 3 development of semaglutide within Alzheimer’s disease,” says Mads Krogsgaard Thomsen, executive vice president and chief scientific officer at Novo Nordisk. “Alzheimer’s disease has been an area of extensive research in the past decades, unfortunately without any major medical breakthroughs. Due to the growing unmet medical need and the increasing evidence of a potential therapeutic role for GLP-1, we will investigate the benefits of oral semaglutide in early Alzheimer’s disease.”