Novo Nordisk’s GLP-1/amylin combo has topped blockbuster semaglutide in a phase 3 Type 2 diabetes trial, though CagriSema still didn’t hit the 25% weight loss mark that the Danish pharma had previously laid out for its next-gen metabolic asset.
A once-weekly shot of CagriSema, which combines semaglutide with the experimental amylin receptor agonist cagrilintide, reduced patients’ blood sugar by 1.91% on average from a baseline of 8.2% and dropped their weight by 14.2% after 68 weeks, Novo announced on Feb. 2. Injectable semaglutide, better known as Ozempic and Wegovy, came up short with reductions of 1.76% and 10.2%, respectively.
“By combining semaglutide and cagrilintide, we’re seeing superior outcomes in both blood glucose control and weight reduction beyond those achieved with each therapy individually,” Martin Holst Lange, M.D., Ph.D., Novo’s R&D chief, said in the release.
“The results strengthen our belief that CagriSema could be the first amylin-based combination therapy and a promising treatment option for individuals with type 2 diabetes,” Lange added, noting that these patients are also focused on losing weight.
The phase 3 study enrolled 2,734 patients from around the world. Novo plans to share detailed data from the trial later this year, according to the release.
Novo has already submitted CagriSema to the FDA for approval in weight loss, leveraging data from two prior phase 3 trials. In those studies, too, the highly anticipated combo failed to reach Novo’s prior bar of 25% weight loss. The first study came close with 22.7%, but efficacy plummeted to 15.7% in the second, taking the pharma’s share price down with it.
Investors weren’t as shaken up by this trial result. Novo’s share price dipped slightly from $59.43 at Friday’s close to $57.92, but by 11:00 a.m. ET, it had bounced back up to around $59 per share.
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The Danish giant plans to approach the FDA to discuss CagriSema’s path forward in Type 2 diabetes once results are in from two other phase 3 trials, one focused on cardiovascular outcomes and the other testing the combo shot against placebo in patients with inadequately controlled diabetes, according to the release.
Should it be approved for weight loss this year, CagriSema could bring in more than $17 billion by 2032, according to an estimate from Evaluate, more than the around $12 billion predicted for Eli Lilly’s oral GLP-1 candidate orforglipron.
During a fireside chat at the J.P. Morgan Healthcare Conference in January, newly minted Novo CEO Maziar Mike Doustdar said CagriSema’s approval is “coming up sometime late this year.”
Novo beat rival Lilly to the oral GLP-1 market with a pill version of Wegovy in December, and is currently hunting for new metabolic assets to add to its focused pipeline.
