Novo Nordisk's CagriSema data disappoints investors again
Novo Nordisk has reported the second phase 3 trial of its new obesity hopeful CagriSema but, as with the first, the topline weight-loss result has sent its shares into a sharp decline.
The stock was trading down more than 5.5% at the time of writing following the revelation that in the REDEFINE 2 trial, CagriSema (cagrilintide and semaglutide) achieved a weight loss of 15.7% after 68 weeks among patients who adhered to treatment with the once-weekly injectable drug, which was significantly ahead of the 3.1% seen with placebo but well below expectations.
In December, Novo Nordisk reported that CagriSema was able to muster a 22.7% weight loss at 68 weeks in REDEFINE 1, which also fell short of its hoped-for reduction of 25%.
The company has already acknowledged that the results from the first study were disappointing, saying in February that it plans to start an additional trial that will look at a new personalised approach to dosing with CagriSema and a longer period of follow-up, but there's no doubt that the even poorer performance in REDEFINE 2 has further undermined confidence in the asset.
Looking at the overall population, including those who may have missed doses, CagriSema achieved a weight loss of 13.7% compared to 3.4% with placebo.
Novo Nordisk made little comment on the data, other than to say that it expects to file the drug for approval in the first quarter of 2026 and "look forward to bringing this second pivotal trial to regulatory authorities with the aim of making this next-generation therapy available to the millions of patients in need."
Previously, it had hoped the drug would be ready for marketing applications before the of this year.
The company has been hoping that CagriSema can improve on the efficacy of its single-agent obesity drug Wegovy (semaglutide) and help defend its obesity franchise against Eli Lilly – whose dual GIP/GLP-1 agonist Zepbound (tirzepatide) proved more effective at reducing weight in a head-to-head trial and has been growing quickly.
Novo Nordisk has previously suggested that one reason for the disappointing data was a flexible treatment protocol in both studies that allowed patients to scale down their dosing if, for example, they experienced side effects.
In REDEFINE 1, only around 57% of patients reached the maximum target dose, while in REDEFINE 2, it was around 61.9%, with both studies using the same 2.4mg dose of calcitonin receptor agonist cagrilintide and 2.4mg of GLP-1 agonist semaglutide. Novo Nordisk has not yet indicated why it thinks the topline weight reduction in the second trial was so much worse than the first.
The company is also running the REDEFINE 3 cardiovascular outcomes study in patients with established cardiovascular disease with or without type 2 diabetes, and the REDEFINE 4 study pitting CagriSema directly against Zepbound.
