Novo Nordisk's experimental obesity pill shows mild to moderate side effects in early tests

In comparison, weight loss in the Wegovy studies was approximately 6% after 12 weeks and 15% after 68 weeks.

The company presented all data from the Phase I study at the meeting of the European Association for the Study of Diabetes in Madrid.

“What we see over the study period is a weight loss of 13.1 percent with a side effect profile comparable to what we normally see with incretin-based therapy, i.e. mainly gastrointestinal side effects,” said Martin Holst Lange, Novo's head of development, in an interview ahead of the presentation.

According to data presented at the conference, one serious but non-fatal adverse event was reported during the study involving 60 participants. There were no reports of serious adverse events in patients taking amycretin, while there were a total of 242 reports of mild and moderate adverse events.

Amycretin targets the same gut hormone that Wegovy mimics, known as GLP-1, but also a pancreatic hormone called amylin, which affects hunger.

The amycretin study resulted in side effects related to gastrointestinal complaints, such as nausea and vomiting, that were similar to those seen in studies of the company's other drugs in the same GLP-1 drug class, the company said.

Novo is also developing another two-drug combination called CagriSema, which also targets the hormone amylin and can lead to weight loss of up to 25%, according to the company.

“The data I’ve seen so far suggests that amycretin has at least the same weight loss potential as CagriSema,” Lange said.

In the study, overweight or obese patients without diabetes received increasing doses of amycretin, starting with three milligrams and up to a final dose of two 50 mg tablets, Novo said.

Patients taking 50 mg of amycretin reduced their body weight by an average of 10.4% at the end of the 12-week study, while those taking the maximum dose of 2 x 50 mg lost 13.1% of their baseline weight, the company said. Weight loss did not plateau after 12 weeks. In comparison, the average weight loss for those taking a placebo was 1.1%.

The data justify further clinical development, Lange said.

A decision on whether to skip a Phase II trial for amycretin and go straight to Phase III – usually the final phase of human testing before seeking approval – will be made once data from an early study of a subcutaneous version of the drug are available next year.

Novo shares have more than tripled since June 2021, when Wegovy launched in the U.S., but have fallen 15% since their peak in June this year.

About 40 percent of Novo's valuation is tied to its pipeline of experimental drugs, Berenberg analysts said last week.

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Based in Copenhagen, Jacob is responsible for reporting from Denmark, Iceland, Greenland and the Faroe Islands. He specializes in security and geopolitics in the Arctic and Baltic Sea, as well as major companies such as obesity drug maker Novo Nordisk, brewery Carlsberg and shipping group Maersk. Before moving to Copenhagen in 2016, Jacob spent seven years in Moscow covering the Russian oil and gas industry for Dow Jones Newswires and The Wall Street Journal. He then spent four years in Singapore covering energy markets for WSJ and Reuters.

Maggie is a UK-based reporter covering the European pharmaceutical industry from a global perspective. In 2023, Maggie's coverage of Danish drugmaker Novo Nordisk and its race to increase production of its new weight-loss drug helped the Health & Pharma team win the Reuters Journalist of the Year award in the Beat Coverage of the Year category. Since November 2023, she has also been contributing to Reuters' coverage of the Israel-Hamas war. Previously, Maggie worked for Reuters in Nairobi and Cairo, and for the Financial Times in Lagos. She began her journalism career in 2010 as a freelancer for The Associated Press in South Sudan.