Novo Nordisk’s Weight-Loss Pill Moves Ahead, Despite Some Serious Side Effects

Novo Nordisk is making progress on its new products. The Danish drugmaker said Wednesday that its long-awaited experimental weight-loss pill, amycretin, was safe and tolerable for patients in an early-phase trial , with mild to moderate side effects. The maker of blockbusters Wegovy and Ozempic said in March that a Phase I trial of the amycretin pill showed participants lost up to 13.1% of their weight after 12 weeks, giving its shares an 8% boost.

These data contrast with the weight loss of around 6% after twelve weeks and 15% after 68 weeks in the Wegovy trials. “What we observed in the study period is a weight loss of 13.1% 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, head of development at Novo Nordisk, in an interview ahead of the presentation.

According to data presented at the European Association for the Study of Diabetes conference in Madrid, one serious but non-fatal adverse event was reported during the trial involving sixty participants. There were no reports of serious side effects for patients taking amicretin, while there were a total of 242 reports of mild and moderate side effects. Amicretin targets the same gut hormone that Wegovy mimics, known as GLP-1, but also a hormone in the pancreas called amylin that affects hunger.

In the amicretin trial, side effects were linked to gastrointestinal upset, including nausea and vomiting, similar to those seen in trials of its other drugs in the same GLP-1 class of drugs, Novo Nordisk said.

Novo Nordisk is also developing another two-drug combination known as CagriSema, which also targets the hormone amylin. It has a weight-loss potential of up to 25 percent, Novo Nordisk said. “The data I’ve seen so far suggests that amylin has at least the same weight-loss potential as CagriSema,” Lange said.

Novo Nordisk has tripled its share price since June 2021

In the study, overweight or obese patients without diabetes were given increasing doses of amylin, starting with three milligrams and ending with a final dose of two 50-milligram pills, according to data presented by Novo Nordisk.

Patients taking 50 milligrams of amylin at the end of the 12-week trial lost body weight by an average of 10.4 percent, while those taking the maximum dose of 2×50 mg lost 13.1 percent of their initial weight, the company said. The weight loss did not plateau at the end of the 12 weeks. That compared with an average weight loss of 1.1 percent among those taking a placebo. The data calls for further clinical development, Lange added .

A decision remains pending on whether to skip a Phase II trial for amicretin and move directly to Phase III, typically the final stage of human testing before seeking approval, once data from an initial study on a subcutaneous version of the drug is ready next year.

Existing obesity drugs, such as Wegovy and Eli Lilly’s Zepbound, are injectable. Pills require larger amounts of active ingredients, which can make them more expensive to produce , but they are often the preferred treatment for patients.

Both companies are racing to ramp up production of the active ingredients needed to make their highly sought-after GLP-1-based anti-obesity drugs.

Novo Nordisk shares have more than tripled since June 2021, when it launched Wegovy in the United States, but have lost 15% since peaking in June this year.

Around 40% of the Danish drugmaker’s valuation is tied to its portfolio of experimental drugs, analysts at Berenberg said last week. Last year, Novo Nordisk became Europe’s most valuable listed company, ahead of luxury giant Lvmh.

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(Featured image by Diana Polekhina via Unsplash)

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