June 20 (Reuters) - Novo Nordisk on Friday
said full results from early-stage trials show that its
experimental drug, amycretin, helped overweight and obese adults
lose up to 24% of their weight as the Danish company readies for
late-stage studies to start next year.
The company said side effects of the drug, tested as both a
weekly injection and a daily pill, were mostly gastrointestinal
with rates similar to other recent weight loss drugs.
The full trial results were presented at the annual meeting
of the American Diabetes Association in Chicago and published in
the Lancet medical journal.
Novo's head of development Martin Holst Lange said the Phase
3 amycretin program starting in 2026 will run "for a couple of
years" after which the regulatory review process could start.
The company earlier this month said it planned to start
late-stage trials of the drug in the first quarter of 2026 after
previously announcing the early-stage trial results.
Amycretin has a dual-mode action. Like Novo's popular
weight-loss drug Wegovy, it mimics the gut hormone GLP-1, but
also targets receptors for a hunger-suppressing pancreatic
hormone called amylin.
Trial results showed that 20-milligram weekly injections of
the drug helped overweight or obese patients without diabetes
lose 22% of their weight over 36 weeks, with a 60-mg dose
resulting in 24.3% weight loss.
In the Phase 1 study of once-daily oral amycretin, patients
received increasing doses, ranging from 3 mg to a final dose of
100 mg. Patients who took 50 mg of amycretin at the end of the
12-week trial reduced body weight by 10.4% on average, while
those taking the maximum dose lost 13.1% of their weight, the
company said.
Novo said the weight loss did not plateau, suggesting that
longer treatment could lead to greater weight loss.
In a Lancet commentary, researchers not involved in the
amycretin studies said that "while additional weight loss is
welcome and helpful, our evolving concept of obesity management
has now shifted towards an emphasis on the reduction of the
risks and burdens of cardiovascular disease and other
comorbidities."
Commentators Tricia Tan, professor of metabolic medicine and
endocrinology at Imperial College London, and endocrinologist
Dr. Bernard Khoo, said studies directly comparing GLP-1 drugs
like Novo's Ozempic to drugs like amycretin will be needed to
definitively establish their added value and place in obesity
management.