Novo Nordisk's Weight Loss Injection CagriSema Data Sparks Investor Concern

On Sunday, The New England Journal of Medicine (NEJM) published results from Novo Nordisk A/S‘ (NYSE:NVO) phase 3 REDEFINE 1 trial of CagriSema plus lifestyle interventions for weight loss in adults with obesity or overweight who have a weight-related medical complication and without diabetes.

CagriSema is being investigated by Novo Nordisk as a once-weekly subcutaneous injectable treatment for adults with overweight or obesity (REDEFINE programme) and as a treatment for adults with type 2 diabetes (REIMAGINE programme).

CagriSema is an investigational product that combines the GLP-1 RA, semaglutide, with an amylin analog, cagrilintide.

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REDEFINE 1 Trial

If all patients adhered to treatment, CagriSema resulted in a greater weight loss of 22.7% at 68 weeks versus 2.3% in the placebo group.

When evaluating the treatment effect regardless of adherence, those treated with CagriSema achieved a statistically significant weight loss of 20.4% at 68 weeks versus 3.0% for the placebo group.

In addition, a supportive secondary analysis showed that half (50.7%) of trial participants with obesity treated with CagriSema reached the threshold for non-obesity (BMI < 30 kg/m2) at the end of treatment, from a mean BMI of 38 kg/m2 at the start of treatment.

In the placebo group,10.2% reached that threshold at 68 weeks.

Select confirmatory secondary endpoints showed that if all participants adhered to treatment, 40.4% of those receiving CagriSema achieved a weight reduction of ≥25%.

Additionally, 23.1% lost ≥30% of their ...