Novo Nordisk's Amycretin Causes 13.1% Weight Loss in 12 Weeks, 242 Adverse Effects Reported

Novo Nordisk revealed on Wednesday that its new weight loss drug, Amycretin, demonstrated favorable safety and tolerability in early trials, showing mostly mild to moderate side effects. The company, known for its diabetes treatments Wegovy and Ozempic, had announced in March that its oral insulin mimetic reduced body weight by 13.1% over 12 weeks in a phase I trial, which boosted its stock by over 8%.

In comparison, Wegovy resulted in a 6% body weight reduction after 12 weeks and 15% after 68 weeks in a similar study. Full data from the phase I trial was presented at the European Association for the Study of Diabetes conference, leading to a 2.4% rise in Novo Nordisk's shares by 1307 GMT. Martin Holst Langer, head of research and development at Novo Nordisk, mentioned in a pre-conference interview that the study observed a 13.1% weight reduction with side effects similar to those seen in incretin-based therapies, primarily gastrointestinal issues.

The data disclosed at the conference indicated one serious but non-fatal adverse event among the 60 participants. There were no severe side effects linked to Amycretin, but 242 mild to moderate adverse events were recorded. Amycretin aims to replicate the GLP-1 gut hormone modeled by Wegovy and also targets the hunger-regulating pancreatic hormone amylin. Novo Nordisk noted that Amycretin’s side effects, including nausea and vomiting, were consistent with other GLP-1 class drug trials.

Novo Nordisk is also working on another combination drug called CagriSema, which targets the pancreatic peptide hormone and may achieve a 25% weight loss. Langer commented that preliminary data suggest that the pancreatic enzyme possesses at least comparable weight loss potential to CagriSema.

In the trial, overweight or obese participants without diabetes were administered progressively increasing doses of Amycretin, beginning at 3 milligrams and culminating in two 50-milligram pills. After 12 weeks, participants taking 50mg of Amycretin saw an average 10.4% body weight reduction, while those on the maximum dose of 2x50mg experienced a 13.1% reduction. This weight loss did not plateau after 12 weeks. Those on a placebo showed a 1.1% average body weight loss. Langer indicated that these findings justify further clinical research.

A decision on whether to bypass the Phase II trial and proceed directly to Phase III, which is typically the final stage before seeking regulatory approval, will be made next year once data from an initial study of a subcutaneous version of the drug becomes available. Current weight-loss medications like Wegovy and Eli Lilly’s Zepbound are injectables. Pills, while requiring a larger quantity of active ingredients and being more costly to produce, are often preferred by patients.

Both Novo Nordisk and Eli Lilly are striving to increase the active ingredient necessary for the highly demanded GLP-1 weight-loss drugs. Since Wegovy was launched in the U.S. in June 2021, Novo Nordisk’s shares have more than quadrupled but have declined by 15% from their peak in June this year. Berenberg analysts stated last week that approximately 40% of Novo Nordisk’s valuation is tied to its experimental drugs in development. Last year, Novo Nordisk overtook LVMH to become Europe's most valuable listed company.

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