A phase 3 trial of Novo Nordisk’s next-generation obesity prospect CagriSema has failed to achieve the level of weight loss targeted by executives, prompting investors to wipe 19% off the value of the Danish drugmaker.
Novo executives repeatedly predicted CagriSema could achieve weight loss of at least 25% on calls with investors throughout 2023 and 2024. Martin Holst Lange, executive vice president of development at Novo, repeated the 25% prediction at investor events last month. But having set the bar, Novo failed to clear it in data published Friday.
After 68 weeks, people on CagriSema lost 22.7% of their body weight. The figure was higher than in people who received the amylin analogue cagrilintide or GLP-1 drug semaglutide—the two molecules combined in CagriSema—as monotherapies. CagriSema comfortably beat weight loss on placebo, too.
The victories counted for little in the eyes of investors on Friday morning. Having been primed to expect weight loss of 25% or more, investors responded to the 22.7% figure by sparking the biggest stock drop in Novo’s history. The stock plunged as much as 26% before stabilizing around a 19%-to-20% drop.
In a statement, Lange said that “only 57% of patients reached the highest CagriSema dose,” offering a pointer to one potential way to dial up the efficacy. In the cagrilintide and semaglutide arms, respectively 82.5% and 70.2% of patients reached the top dose. The trial used a flexible protocol that allowed patients to modify their dosing throughout the study.
Around 40% of patients who received CagriSema reached a weight loss of 25% or more after 68 weeks. The drugmaker is yet to discuss whether those patients were more likely to be on the highest dose or explain why so many patients on CagriSema topped out at lower doses. Novo said the drug combination “appeared to have a safe and well-tolerated profile.”
The company plans to use lessons learned in the phase 3 trial, which enrolled 3,417 people with obesity or overweight and one or more comorbidities, to “further explore the additional weight loss potential of CagriSema,” Lange said. A second pivotal phase 3 trial of CagriSema, which enrolled adults with type 2 diabetes and either obesity or overweight, is expected to report data in the first half of 2025.
The failure of CagriSema to live up to Novo’s expectations could create opportunities for rivals. Eli Lilly’s Zepbound beat Novo’s Wegovy in a recent head-to-head trial and a who’s who of drug developers are advancing candidates designed to dislodge the current incumbents.