Novo Nordisk has submitted a new drug application to the U.S. Food and Drug Administration (FDA) for its injectable obesity treatment, CagriSema. The drug is intended for adults who are obese or overweight and have at least one weight-related health condition.
CagriSema combines two components: cagrilintide, a long-acting amylin analogue, and semaglutide, a GLP-1 receptor agonist already approved under the brand names Wegovy for obesity and Ozempic for diabetes. Novo Nordisk described CagriSema as potentially the first injectable therapy that merges an amylin analogue with a GLP-1 receptor agonist.
“Building on the well-established profile of semaglutide and combining it with a novel mechanism of action, CagriSema has the potential to represent a meaningful step forward in the holistic treatment of obesity,” CEO Maziar Mike Doustdar said in a statement.
The FDA filing is supported by results from Novo Nordisk’s Phase III REDEFINE 1 trial. Data released in December 2024 showed that patients taking CagriSema lost an average of 20.4% of their body weight after 68 weeks. This compares to 11.5% weight loss with cagrilintide alone, 14.9% with semaglutide alone, and 3% for those receiving placebo.
Additional data from June indicated that injection-site reactions were reported by 12% of patients on CagriSema. These side effects were linked primarily to cagrilintide; 17% of those taking cagrilintide alone experienced similar reactions, compared to only 2.6% among patients using semaglutide by itself. Analysts noted that while CagriSema’s effectiveness was similar to Eli Lilly’s GLP-1 drug Zepbound, Lilly’s medication did not cause as many injection-site reactions.
In September, Novo Nordisk reported further results showing an average weight reduction of 11.8% among patients treated with CagriSema versus 2.3% in the placebo group. The company stated that the drug was generally well-tolerated, with about 1% discontinuing treatment compared to just over 0.1% in the placebo arm.
Novo Nordisk is competing closely with Eli Lilly in the growing obesity market as both companies seek regulatory approval for new treatments and formulations targeting weight loss.
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