Ozempic warning: experts warn of side effects of weight loss drug
Experts have warned that popular diabetes drugs such as Ozempic and Munjaro can have side effects when used for weight loss purposes.
Despite high expectations and two years of research, Novo Nordisk has no plans to add Alzheimer’s disease to the list of diseases that its blockbuster diabetes and weight loss drugs Ozempic and Wigovy can treat.
The Danish pharmaceutical company recently announced that in two large studies, the active ingredient in its drug, semaglutide, failed to slow cognitive decline in thousands of people in the early stages of the mind-depriving disease.
Novo’s trial was expected to provide clues as to whether GLP-1 drugs, used by millions for diabetes and weight loss, can slow the progression of the disease, which affects more than 7 million Americans. Instead, Alzheimer’s disease researchers expect Novo to present important details about the late-stage study at the Alzheimer’s Disease Scientific Conference in San Diego in early December. They hope to sift through the data to see if it provides biological clues for future Alzheimer’s disease research.
“We’re very interested in seeing the results of these biomarkers and other details of the study,” said Dr. Eric Lyman, executive director of the Banner Alzheimer’s Research Institute in Phoenix.
What did the research find?
Novo Nordisk tested an older pill version of semaglutide, which was previously approved for type 2 diabetes. Novo’s blockbuster products Ozempic and Wigovy are also injectables containing semaglutide. Novo is seeking Food and Drug Administration approval for a tablet of its obesity drug Wegoby called orforglipron.
The two trials enrolled more than 3,800 adults with early Alzheimer’s disease who were randomly assigned to receive semaglutide tablets or a placebo plus standard treatment. The group receiving semaglutide improved disease-related biomarkers, but the drug did not slow disease progression, Novo said.
Novo decided to study semaglutide as a treatment for Alzheimer’s disease based on evidence from other studies, preclinical models, and results from diabetes and obesity studies.
The setback dashes Novo’s hopes that Alzheimer’s disease could open up a major new market for GLP-1 drugs. Positive trial results could help Novo outpace rival Eli Lilly, which has lagged in its core treatment areas of obesity and diabetes.
“The fact that the study was discontinued after two years, despite a planned three-year extension, suggests that semaglutide is virtually ineffective in slowing the progression of Alzheimer’s disease,” Erik Berg Johnsen, portfolio manager at Novo shareholder Storebrand Asset Management, told Reuters.
Alzheimer’s disease researchers search for clues
Howard Fillitt, co-founder and chief scientific officer of the Alzheimer’s Drug Discovery Foundation, said the study results were “disappointing” but “represent a fundamental change in the way we approach developing new Alzheimer’s treatments.”
For decades, Alzheimer’s disease researchers have targeted amyloid beta, a protein that accumulates and forms plaques in the brains of Alzheimer’s patients. The semaglutide trial shows that Alzheimer’s research is “expanding beyond amyloid to target the complete pathobiology of the disease,” Fillit said.
A Novo spokesperson said the company is ending its study of semaglutide as a treatment for Alzheimer’s disease. Novo will present details of its semaglutide research at the Alzheimer’s Disease Clinical Trials scientific conference December 1-4 in San Diego.
These results “may suggest a future path for semaglutide as part of a combination therapy approach,” Fillit said.
Experts say Novo’s report provides immediate clarity for doctors prescribing semaglutide because patients often want to know whether semaglutide can slow cognitive decline.
“This question comes up a lot among patients about the potential benefits and risks,” Lyman says.
Lehman said researchers will look for further clues once Novo presents further research data at the CTAD conference.
He said semaglutide was tested in people who were already experiencing symptoms of Alzheimer’s disease. Lyman, co-director of the Alzheimer’s Disease Prevention Initiative, is among researchers calling for research into whether treating Alzheimer’s patients early can slow memory and thinking problems.
“My own guess is that if semaglutide is effective, it will be even more effective in people without the disorder,” he said before Alzheimer’s disease became widespread.
Contributed by: Reuters
