Experimental Pill by Novo Nordisk Shown to Have Side Effects in Trial

Amycretin, Novo Nordisk’s much-anticipated experimental weight-loss drug, was found to be safe in an early-stage trial, with mild to moderate side effects, the company reported on Wednesday.

In March, the manufacturer of the popular medications Wegovy and Ozempic announced that a Phase I trial of the tablet form of amycretin achieved weight loss of over 13% after 12 weeks. This news caused the stock to soar more than 8%. In the same trials for Wegovy, the weight loss was around 6% after 12.

“What we see in the study period is a 13.1% weight loss with a side effect profile comparable to what we normally see with incretin-based therapy, so primarily gastrointestinal side effects,” Martin Holst Lange, who spearheads Novo’s R&D department, stated.

According to the information provided at the conference, one significant adverse event was observed during the study with 60 participants; however, it was not fatal. Amycretin had 242 complaints of mild to moderate negative effects, but no reports of serious side effects from patients.

Amycretin regulates hunger by targeting the same hormone that Wegovy mimics—GLP-1—in addition to a pancreatic hormone called amylin.

The company stated that the amycretin trial’s adverse effects were consistent with its other GLP-1 medication class treatments, including gastrointestinal distress, nausea, and purging.

Novo claimed that its new two-drug combination, CagriSema, aimed at the amylin hormone as well, might lead to a weight reduction of up to 25%.

Novo reported that the study’s participants were non-diabetic adults who were overweight or obese and given a progressive regimen of amycretin, beginning with 3 milligrams and ending with two 50 mg tablets.

At the close of the 12-week experiment, patients using 50 mg of amycretin had a 10.4% weight loss, while those getting the highest dose of 2×50 mg had a 13.1% weight loss, according to the firm. In comparison, those who took the placebo had an average weight loss rate of just above 1%. After the 12-week period had elapsed, there was still no sign of a weight reduction plateau.

Once results from early research on a subcutaneous form of the medicine are known next year, a decision will be made regarding skipping a Phase II study for amycretin and going straight to phase III, the last step of human testing, before looking for approval.

Existing injectable obesity medications include Wegovy and Zepbound (manufactured by Eli Lilly). Patients generally prefer pills, despite the fact that their production might be more expensive due to the higher quantity of active chemicals required.

Both companies are in an anxious race to meet the rising demand for their GLP-1 obesity medications by increasing the production of the active components.

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