Despite hitting its primary endpoints, the Novo Nordisk REDEFINE 1 Phase III trial saw patients achieving a weight loss of 22.7% after 68 weeks on CariSema. Credit: Getty Images / Bloomberg

Danish mega-company Novo Nordisk has taken a hit after its newest experimental weight loss drug, CagriSema, fell short of expectations sending the company’s stock price spiralling.

Despite hitting its primary endpoints, the company’s REDEFINE 1 Phase III trial (NCT05669755) saw patients achieving a weight loss of 22.7% after 68 weeks on CariSema compared to a reduction of 11.8% with cagrilintide 2.4 mg or 16.1% with semaglutide. Despite this, results fell short of the 25% weight loss the company had previously set as its goal.

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In response to the 20 December announcement, the company’s value plummeted by more than 26% from an estimated 739dkk ($102) per share, down to 540dkk ($75) before levelling out again at 594dkk ($82) at the time of publication.

The REDEFINE-1 trial enrolled 3,400 adults with obesity or were overweight with one or more comorbidities and without type 2 diabetes. Despite falling short of previously announced targets Novo Nordisk is still positive on meeting the primary endpoint of efficacy over placebo.

 Martin Holst Lange, executive vice president for development at Novo Nordisk, said: “We are encouraged by the weight loss profile of CagriSema demonstrating superiority over both semaglutide and cagrilintide in monotherapy in the REDEFINE 1 trial. This was achieved even though only 57% of patients reached the highest CagriSema dose.

“With the insights obtained from the REDEFINE 1 trial, we plan to further explore the additional weight loss potential of CagriSema.”

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CagriSema is described by Novo Nordisk as a fixed-dose combination of a long-acting amylin analogue, cagrilintide alongside semaglutide. The latter of the two is the active ingredient Novo Nordisk’s flagship weight loss and type 2 diabetes drugs Ozempic and Weygovy, both of which are responsible for the company hitting a market cap of $2.62 trillion. GlobalData predicts CagriSema to make sales of $15.86bn in 2030. GlobalData is the parent company of Clinical Trials Arena.

The REDFINE-1 trial comes as part of a set of four trials run by the company, all examining the use and safety of once-weekly subcutaneous CagriSema in obesity. The drug is also being investigated in adults with type 2 diabetes as part of the REIMAGINE series of trials.

This is the second hit for Novo Nordisk’s weight loss portfolio in December after its major competitor Eli Lilly saw patients in a Phase III study of its weight loss drug Zepbound (tirzepatide) experiencing 47% more relative weight loss than Wegovy.