Novo Nordisk Releases Topline Results From Phase 3 REIMAGINE 5 and REDEFINE 9 Trials Of Once-Weekly Cagrisema (Cagrilintide and Semaglutide)

Novo Nordisk today 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. The findings were highlighted at Novo’s Capital Markets Day investor briefing.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 HbA1c (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.Also during Capital Markets Day, Novo presented data on painful diabetic neuropathy in type 2 diabetes for the first time, showing promising results. More details will be presented at a later time.Trial key resultsTrialPopulationTreatmentPrimary EndpointsKey ResultsREIMAGINE 5Adults with type 2 diabetes (inadequately controlled on metformin, SGLT2i, or both)CagriSema 1.0 mg/1.0 mg vs. tirzepatide 5 mg1) Change in HbA1c2) Relative change in body weight(week 60)Weight loss: 12.4% (CagriSema) vs. 9.1% (tirzepatide) – superiorHbA1c reduction: 1.71% (CagriSema) vs. 1.67% (tirzepatide) – non-inferiorREDEFINE 9Adults with overweight or obesity (adjunct to diet & exercise)CagriSema 1.0 mg/1.0 mg vs. placebo1) Relative change in body weight2) Proportion achieving ≥5% weight reduction(week 68)Weight loss: 21.0% (CagriSema) vs. 2.0% (Placebo) – superiorAbout the REIMAGINE 5 trialREIMAGINE 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 HbA1c and relative change in body weight from baseline to week 60.About the REDEFINE 9 trialREDEFINE 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.About CagriSemaOnce-weekly subcutaneous CagriSema is being investigated by Novo as a treatment for adults with overweight or obesity (REDEFINE programme) and as a treatment for adults with type 2 diabetes (REIMAGINE programme). CagriSema is a fixed-dose combination of a long-acting amylin receptor agonist, cagrilintide, and a GLP-1 receptor agonist, semaglutide.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.