An oral formulation of semaglutide, the active ingredient in the well-known medications Ozempic and Wegovy, has not demonstrated efficacy in slowing the progression of Alzheimer’s disease during pivotal clinical trials. This announcement was made by Novo Nordisk on Monday.
The company conducted two Phase 3 trials involving over 3,800 adults who were receiving standard care for Alzheimer’s. The trials aimed to assess whether the oral semaglutide pill would prove more effective than a placebo. Although the treatment was found to be safe and showed improvements in Alzheimer’s-related biomarkers, it ultimately did not delay the progression of the disease.
Novo Nordisk had previously regarded Alzheimer’s as a speculative area for the popular GLP-1 drugs, which have gained significant traction for their roles in managing diabetes and assisting with weight loss. In recent years, these medications have also been associated with benefits across various health conditions, including heart and kidney protection, alleviation of sleep apnea, and potential advantages in treating addiction.
While smaller studies and animal research hinted at the possibility that GLP-1s could help mitigate cognitive decline or reduce neuro-inflammation, larger trials such as those conducted by Novo were deemed necessary to establish tangible patient benefits.
“In light of the considerable unmet need in Alzheimer’s disease and a range of suggestive data points, we felt it was our responsibility to investigate the potential of semaglutide, despite recognizing the low likelihood of success,” said Martin Holst Lange, the company’s chief scientific officer and executive vice president of Research and Development. He expressed gratitude to the participants in the trials.
Consequently, Novo announced that a one-year extension of the trials will not proceed. The results have yet to undergo peer review or publication, but they are expected to be shared at forthcoming scientific conferences.
In the wake of the trial results, Novo has faced mounting competition in the weight loss segment and has recently adjusted prices for certain patients using Ozempic and Wegovy. Following the announcement about the Alzheimer’s trial, shares of Novo declined sharply on Monday.
