Novo Nordisk's New Drug Amycretin Leads to 13.1% Weight Loss in 12 Weeks, but Reports 242 Adverse Effects!

Novo Nordisk announced on Wednesday that its new experimental weight loss drug Amycretin showed good safety and tolerability in preliminary trials, with only mild to moderate adverse effects. The maker of diabetes treatments Wegovy and Ozempic reported in March that its oral insulin mimics reduced body weight by 13.1 percent over 12 weeks in a phase I trial, sending its shares up more than 8 percent.

In contrast, Wegovy lost about 6 percent of her body weight after 12 weeks and 15 percent after 68 weeks in a similar trial. Novo Nordisk presented full data from the phase 1 study at the European Association for the Study of Diabetes conference, and the company's shares were up 2.4 percent by 1307 GMT.

"During the study period, we observed a 13.1 percent weight loss and side effects comparable to those of incretin based treatments, mainly gastrointestinal side effects," Martin Holst Langer, head of research and development at Novo Nordisk, said in an interview ahead of the meeting.

According to data presented at the meeting, one serious but non-fatal adverse event was reported in the 60-participant trial. There were no reports of serious side effects among those taking Amycretin, but a total of 242 mild and moderate side effects were reported.

Amycretin is designed to mimic the GLP-1 gut hormone modelled by Wegovy, and also affects the hunger pancreatic hormone amylin. Novo Nordisk said Amycretin's side effects, mainly related to gastrointestinal discomfort, including nausea and vomiting, were similar to other drug trials in the same GLP-1 drug class.

The company is also developing another two-drug combination called CagriSema, which also targets the pancreatic peptide hormone, which Novo Nordisk says has the potential to lead to a 25 percent weight loss. "The data I've seen so far suggest that pancreatic enzyme has at least the same weight loss potential as CagriSema," Lange said.

Novo Nordisk said that in the study, overweight or obese patients without diabetes received gradually increasing doses of Amycretin, starting with 3 milligrams and ending with two 50-milligram pills. At the end of the 12-week trial, patients taking 50mg of Amycretin lost an average of 10.4 percent of their body weight, while those taking the maximum dose of 2x50mg lost 13.1 percent. After 12 weeks, weight loss did not plateau. In comparison, those taking the placebo lost an average of 1.1 percent of their body weight. Lange believes these data warrant further clinical investigation.

Next year, once data from an early study of a subcutaneous version of the drug is ready, a decision will be made on whether to skip the Phase II trial and go straight to Phase III - usually the final stage before seeking approval. Existing weight-loss drugs such as Wegovy and Eli Lilly's Zepbound are injectable. Pills require a large number of active ingredients, which makes them more expensive to produce but often favored by patients.

Both companies are racing to increase the active ingredient needed to make the much-needed GLP-1 weight-loss drug. Novo Nordisk shares have more than quadrupled since launching Wegovy in the United States in June 2021, but have fallen 15 percent since peaking in June this year. Analysts at Berenberg said last week that about 40 percent of Novo Nordisk's valuation depends on the experimental drugs it has in development. Last year Novo Nordisk became Europe's most valuable listed company, ahead of LVMH.