CagriSema delivers superior weight loss versus tirzepatide in REIMAGINE 5 trial – Novo

Novo Nordisk announced topline results from the phase 3 REIMAGINE 5 and REDEFINE 9 trials of once-weekly CagriSema (cagrilintide and semaglutide), an investigational product, and Novo’s next innovation in weight management and type 2 diabetes.

In REIMAGINE 5, CagriSema 1.0 mg/1.0 mg was superior to tirzepatide 5 mg for weight loss, achieving an estimated average weight loss of 12.4%, compared with 9.1%, respectively. CagriSema also confirmed non-inferior reduction in HbA_1c (1.71%) versus tirzepatide (1.67%).

In REDEFINE 9, CagriSema 1.0 mg/1.0 mg provided a weight reduction of 21.0% versus 2.0% for placebo, and the primary superiority endpoint was met. CagriSema also showed greater improvements than placebo across prespecified supportive endpoints, including systolic blood pressure, waist-to-height ratio and fasting lipid profile.

“The results from CagriSema are very encouraging, demonstrating the strong potency of the combination of semaglutide and cagrilintide. With only 1.0 mg/1.0 mg, CagriSema shows superior weight loss versus tirzepatide 5 mg as well as strong results across obesity and type 2 diabetes,” said Martin Holst Lange, executive vice president, Research & Development and chief scientific officer at Novo. “CagriSema remains investigational, but these findings strengthen our confidence in its potential, add to the growing evidence for amylin biology and reinforce our ambition to advance the next generation of treatments for obesity and type 2 diabetes.”

Treatment decisions in obesity and type 2 diabetes are often individualised, and not all patients receive or remain on the highest available dose of current therapies. These data provide important evidence of the potential of CagriSema 1.0 mg/1.0 mg, and expand our understanding of how efficacy, tolerability and dose flexibility may support individualised care.

Novo filed a New Drug Application with the U.S. Food and Drug Administration in December 2025 for CagriSema for weight management, demonstrating the company’s commitment to lasting health innovation in obesity. A decision is expected in Q4 2026.

About the REIMAGINE 5 trial
REIMAGINE 5 was a phase 3 trial investigating once-weekly CagriSema 1.0 mg/1.0 mg compared with tirzepatide 5 mg in participants with type 2 diabetes inadequately controlled on metformin, an SGLT2 inhibitor or both. The dual primary endpoints were change in HbA_1c and relative change in body weight from baseline to week 60.

About the REDEFINE 9 trial
REDEFINE 9 was a phase 3 trial investigating once-weekly CagriSema 1.7 mg/1.7 mg and CagriSema 1.0 mg/1.0 mg compared with placebo, as an adjunct to a reduced-calorie diet and increased physical activity, in participants living with overweight or obesity. The primary endpoints were relative change in body weight and the proportion of participants achieving at least 5% body-weight reduction from baseline to week 68.