Novo Nordisk says its Alzheimer’s trials for GLP-1 drug semaglutide were justified by prior human, animal, and real-world data, despite missing goals.
SAN DIEGO: Novo Nordisk has defended its decision to launch major Alzheimer’s trials for its GLP-1 drug semaglutide, despite the studies failing to meet their primary goals.
The company’s international medical vice president, Peter Johannsen, said the 2020 trials were based on consolidated data from human, animal, and real-world studies.
“We still think it was the right decision… a scientific question that needed an answer,” Johannsen told the Clinical Trials in Alzheimer’s Disease meeting.
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He cited evidence showing the GLP-1 hormone is involved in neurotransmission and has multiple effects across the brain.
Johannsen acknowledged the complexity of Alzheimer’s disease, which is defined by toxic amyloid plaques.
“This is a very complex disease with a lot of things going on with different genetic signatures,” he said.
The company is set to present initial results from the two-year studies on Wednesday.
The trials tested the diabetes pill Rybelsus against a placebo in nearly 4,000 Alzheimer’s patients.
A short press release last week confirmed the studies did not meet their goals of significantly slowing cognitive decline.
Full results will be presented at a separate medical meeting in March.
Johannsen highlighted retrospective studies showing cognitive benefits for diabetes patients using GLP-1 drugs.
Those gains appeared after about a year of treatment and increased with longer-term use.
He noted that some real-world analyses were based on clinical diagnoses rather than precise amyloid plaque identification.
About 60% of dementia cases are Alzheimer’s disease, with the remainder caused by vascular or other issues.
The executive also pointed to potential biases in the real-world data.
Diabetes patients prescribed GLP-1s likely had specialist care and may be from higher socioeconomic groups.
Better glycemic control from the drugs might also delay dementia diagnosis, he suggested. – Reuters
