Novo Nordisk Reports Positive Phase 3 CagriSema Resultsx

Bagsværd, Denmark, September 21, 2026

Novo Nordisk Reports Strong Weight-Loss Results

The REIMAGINE 5 Phase 3 trial evaluated once-weekly CagriSema 1.0 mg/1.0 mg against tirzepatide 5 mg in adults with type 2 diabetes whose disease was inadequately controlled with metformin, an SGLT2 inhibitor, or both. The study had two primary endpoints: change in HbA1c and relative change in body weight from baseline to week 60. Novo Nordisk reported that CagriSema produced 12.4% weight loss, compared with 9.1% with tirzepatide, establishing superiority for the body-weight endpoint. The treatment also reduced HbA1c by 1.71%, compared with 1.67% for tirzepatide, meeting the predefined criterion for non-inferiority. These findings provide evidence for the potential of the combination to address both glycemic control and body-weight management in adults with type 2 diabetes.

The REDEFINE 9 Phase 3 trial evaluated CagriSema in adults living with overweight or obesity, alongside a reduced-calorie diet and increased physical activity. At week 68, participants receiving CagriSema 1.0 mg/1.0 mg experienced a 21.0% reduction in body weight, compared with 2.0% for placebo, and the trial met its primary superiority endpoint. Novo Nordisk also reported improvements across prespecified supportive measures, including systolic blood pressure, waist-to-height ratio and fasting lipid profile. Together, the findings add to the clinical evidence being generated through Novo Nordisk’s broader REDEFINE and REIMAGINE development programmes.

CagriSema Combines Amylin and GLP-1 Activity

CagriSema is a fixed-dose combination of cagrilintide and semaglutide administered once weekly by subcutaneous injection. Cagrilintide is a long-acting amylin receptor agonist, while semaglutide is a GLP-1 receptor agonist. Novo Nordisk is investigating the combination as a potential treatment for adults with overweight or obesity and for adults with type 2 diabetes. The company reported that CagriSema was generally well tolerated in both Phase 3 trials, with a safety profile consistent with previous studies. However, CagriSema remains investigational and has not been approved as a combination product. Novo Nordisk said the new findings strengthen its development programme around amylin biology and support continued investigation of CagriSema for metabolic disease. The company has already submitted a New Drug Application to the U.S. FDA for CagriSema in weight management, with a regulatory decision expected in the fourth quarter of 2026. The new Phase 3 data therefore arrive as the company continues to advance the candidate through clinical and regulatory development.

Phase 3 Data Expand CagriSema Development

The latest results provide additional information on the potential clinical profile of CagriSema across obesity and type 2 diabetes. In REIMAGINE 5, the combination demonstrated superior weight loss versus the 5 mg tirzepatide comparator while maintaining non-inferior HbA1c reduction. In REDEFINE 9, the candidate delivered substantial weight reduction compared with placebo together with improvements in several cardiometabolic measures. Novo Nordisk presented the findings during its Capital Markets Day investor briefing, while additional details from the studies are expected as the clinical development programme progresses. For cGxP.wire readers, the announcement highlights significant developments in Phase 3 drug development, obesity therapeutics, diabetes treatment, GLP-1 and amylin biology, and metabolic medicine. The results also demonstrate Novo Nordisk’s continued focus on developing combination approaches designed to address the complex relationship between body weight and metabolic disease.

Source: Novo Nordisk press release