Novo Nordisk A/SCagriSema met superiority endpoints in two phase III trials, showing greater weight loss than Lilly's tirzepatide and versus placebo
Novo Nordisk reported top-line results from two phase III studies of once-weekly CagriSema, its investigational fixed-dose combination of cagrilintide and semaglutide, in obesity and type II diabetes. In the 68-week REIMAGINE 5 study, CagriSema 1.0 mg/1.0 mg produced an estimated average body-weight reduction of 12.4% at week 60 versus 9.1% for Eli Lilly's tirzepatide 5 mg, the active ingredient in Zepbound and Mounjaro, meeting the superiority criterion for weight loss, while HbA1c fell 1.71% versus 1.67%, meeting the prespecified non-inferiority criterion. In the separate REDEFINE 9 study, CagriSema 1.0 mg/1.0 mg generated 21% weight loss at week 68 compared with 2% for placebo, meeting the primary superiority endpoint, with greater improvements on supportive measures including systolic blood pressure, waist-to-height ratio and fasting lipid profile. Novo filed a new drug application with the FDA in December 2025 seeking approval of CagriSema for weight management, with a regulatory decision expected in the fourth quarter of 2026. The company cautioned that the weight-loss comparison should be viewed within the specific study design and doses studied rather than as a direct comparison with every approved tirzepatide regimen.
Novo Nordisk A/SCagriSema met superiority endpoints in two phase III trials, showing greater weight loss than Lilly's tirzepatide and versus placebo
Eli Lilly and CompanyNovo's CagriSema beat Lilly's tirzepatide (Zepbound/Mounjaro) on weight loss in the REIMAGINE 5 head-to-head trial
AC Immune Ltd
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