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Novo Nordisk (NOVOb.CO), opens new tab 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, opens new tab 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.
