Novo’s next-gen obesity drug misses expectations in closely watched trial

A new type of obesity drug being developed by Novo Nordisk has fallen short of expectations set by the company in a closely watched Phase 3 trial, causing shares to lose nearly a fifth of their value in early trading on Friday. 

In a statement, Novo said that the drug, a combination therapy called cagrisema, helped people lose up to about 23% of their body weight after 68 weeks, about 20 percentage points higher than placebo recipients and 7 higher than those who received the company’s popular weight loss drug Wegovy alone.  

That weight loss total missed the bar set by Novo executives, who had been hoping that cagrisema would spur about 25% weight loss over the course of the trial. Investors were anticipating as much as 27% weight loss, according to a survey conducted by Jefferies analyst Peter Welford. 

Additionally, patients were allowed to modify their dosing over the course of the trial, and by its end, only about 57% of patients treated with cagrisema were on the highest dose, versus around 70% of those who got Wegovy and around 83% of participants who got cagrilintide, one of the components of cagrisema. The findings suggest “possible tolerability concerns” for cagrisema, Welford wrote to investors Friday. 

Cagrisema is a combination of semaglutide, the active ingredient in Wegovy, and cagrilintide. It’s a once-weekly shot targeting multiple gut hormones that regulate metabolism and hunger. Novo has been looking to it as a way to one-up its key weight loss rival Eli Lilly, whose drug Zepbound helped people lose as much as 21% of their body weight in clinical testing. 

Unlike Zepbound, which targets two gut hormones with a single drug, cagrisema’s two components are injected separately with a dual-chamber pen device. That delivery method could limit its commercial outlook given the struggles drug companies have had keeping up with demand for weight-loss medicines. Still, Novo has been hoping cagrisema might prove clearly more effective than its chief rival, even going so far as to test the drug against Zepbound in a Phase 3 trial that’s expected to produce results in the second half of 2025. 

The trial results announced Friday are a blow to Novo’s obesity ambitions, then, disappointing analysts and investors eager for signs it can continue to dominate a drug class projected to eventually surpass $100 billion in yearly sales. David Risinger, an analyst with Leerink Partners, wrote that, in light of the findings, “it is now questionable whether cagrisema will be able to demonstrate weight loss superiority over Zepbound.”

Novo is not only battling with Lilly, but trying to stay ahead of a host of other biotechnology companies eyeing a share of the market. 

In the trial, Novo enrolled 3,417 people with a body mass index greater than 30 or above 27 and with one weight-related health condition. Trial investigators randomized them to take cagrisema, semaglutide and a placebo, cagrilintide and a placebo, or two placebo drugs.

The main objective was a comparison of cagrisema to the two placebos on weight loss. Secondary study goals included comparing weight loss for people receiving the combination to those who got the single drugs.

Shares fell about 20% in early trading on Friday, while Lilly shares climbed about 6%. 

Still, to Prakhar Agrawal, an analyst with Cantor Fitzgerald, the results had at least one silver lining. The cagrilintide component of cagrisema outperformed investor expectations, leading to 12% of weight loss in those who received it. That’s a sign targeting the gut hormone amylin, as cagrilintide does, could hold promise treating obesity. Zealand Pharma, AstraZeneca and startup Metsera are among the drugmakers with amylin-targeting therapies in development. 

Novo has a second Phase 3 study of cagrisema called Redefine 2 and that’s expected to produce results in 2025. It’s also working on another drug combination it calls amycretin as a weekly shot and daily pill. 

Editor’s note: This story has been updated with analyst commentary.

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