United States / Denmark
Novo Nordisk has submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for CagriSema, an investigational once-weekly injectable therapy intended for chronic weight management in adults with obesity or overweight accompanied by at least one weight-related medical condition.
CagriSema is a fixed-dose combination therapy that brings together cagrilintide, a long-acting amylin analogue, and semaglutide, a GLP-1 receptor agonist. If approved, the therapy would become the first injectable treatment combining GLP-1 and amylin analogue mechanisms, designed to address multiple biological pathways involved in appetite control, satiety, and energy balance.
The FDA submission is supported by data from Novo Nordisk’s REDEFINE phase 3 clinical program, which evaluated the efficacy and safety of CagriSema across several patient populations. In the REDEFINE 1 study, adults with obesity or overweight without diabetes achieved average body-weight reductions exceeding 20 percent over a 68-week treatment period, significantly greater than placebo. When evaluating participants who remained on treatment, average weight loss approached 23 percent.
A high proportion of study participants achieved clinically meaningful weight reduction of at least 5 percent, and more than half of those classified as obese at baseline reached a body mass index below the obesity threshold by the end of the trial. Additional data from the REDEFINE 2 study in adults with type 2 diabetes further supported the therapy’s weight-loss efficacy when used alongside lifestyle interventions.
Across clinical trials, CagriSema demonstrated a safety profile consistent with therapies in the GLP-1 drug class. The most frequently reported side effects were gastrointestinal, including nausea, constipation, and vomiting, with relatively low treatment discontinuation rates due to adverse events.
Novo Nordisk stated that the application reflects its continued focus on advancing next-generation obesity treatments that target multiple biological drivers of the disease. By combining two complementary hormonal pathways, CagriSema is designed to support both substantial weight reduction and long-term weight maintenance.
The FDA is expected to review the application in 2026. CagriSema is not currently approved for use in the United States or other markets.
Novo Nordisk is a global healthcare company with more than 100 years of experience in metabolic disease care, focused on developing innovative therapies for diabetes, obesity, rare blood disorders, and endocrine conditions.
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