Novo Nordisk has taken a significant step forward in the rapidly evolving landscape of obesity treatment, announcing the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for CagriSema.
The proposed treatment is a fixed-dose, once-weekly injection combining 2.4 mg of cagrilintide, a long-acting amylin analogue, and 2.4 mg of semaglutide, the proven GLP-1 receptor agonist found in the company’s blockbuster drugs Wegovy and Ozempic. The submission seeks approval for CagriSema to be used for long-term weight management in adults with obesity (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2) who have at least one weight-related comorbidity, alongside a reduced-calorie diet and increased physical activity.
The submission follows impressive results from late-stage clinical trials indicating that the combination therapy may achieve weight loss outcomes significantly higher than current market options.
A “New Era” in Weight Management
If approved, CagriSema would become the first injectable treatment to combine these two distinct mechanisms of action. Semaglutide works by mimicking a hormone that targets areas of the brain that regulate appetite and food intake. Cagrilintide mimics amylin, a pancreatic hormone that promotes feelings of fullness and delays gastric emptying. By targeting multiple pathways involved in hunger and satiety, the combination aims to provide a more comprehensive approach to weight loss.
Pivotal Trial Shows Significant Weight Reduction
The NDA submission is bolstered by data from the comprehensive REDEFINE phase 3 clinical program.
A key study in the program, REDEFINE 1, evaluated the drug in 3,417 adults with obesity or overweight who did not have diabetes over a 68-week period. The trial compared CagriSema against semaglutide alone, cagrilintide alone, and a placebo, with all participants undertaking lifestyle interventions.
According to the trial data, participants taking CagriSema achieved an average weight loss of 20.4% at 68 weeks, compared to just 3.0% in the placebo group, when evaluating the effect regardless of treatment adherence.
When analyzing the data in an “idealized scenario” assuming all patients remained on treatment without adding other weight loss therapies—the CagriSema group achieved an even higher average weight loss of 22.7%, versus 2.3% for placebo.
The trial results also highlighted the consistency of the response to the drug. In the REDEFINE 1 trial, 91.9% of participants taking CagriSema achieved a body weight reduction of at least 5%, compared to 31.5% in the placebo group.
Read More: Novo Nordisk’s CagriSema for Obesity and Type 2 Diabetes Shows Superior Results in REDEFINE 2 Trial
Perhaps most notably, a secondary analysis revealed that approximately half (54%) of participants who were obese at the start of the trial and treated with CagriSema dropped below the obesity threshold (BMI <30 kg/m2) by week 68, compared to only 11.1% in the placebo group.
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Safety and Tolerability Profile
The safety data generated in the REDEFINE 1 and REDEFINE 2 trials (the latter conducted in adults with type 2 diabetes) showed a profile comparable to the existing GLP-1 receptor agonist class of drugs.
The most common adverse events reported in REDEFINE 1 were gastrointestinal in nature, affecting 79.6% of the CagriSema group compared to 39.9% of the placebo group. Specific side effects included nausea (55%), constipation (30.7%), and vomiting (26.1%).
Despite the side effects, discontinuation rates due to adverse events remained relatively low. In REDEFINE 1, the discontinuation rate was 5.9% for CagriSema versus 3.5% for placebo.
Doustdar stated that the company believes the data “underscore the potential of CagriSema to address unmet medical needs in obesity and support long-term disease management,” highlighting the drug’s powerful efficacy and high treatment completion rates.
Novo Nordisk anticipates that the FDA will review the CagriSema application during 2026.
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