Novo Nordisk said on September 21, 2026 that it expects an FDA decision on CagriSema, its cagrilintide and semaglutide combination for weight management, in the fourth quarter of 2026.
What changed. The timing came with topline results from two phase 3 trials of a lower 1.0 mg/1.0 mg dose. In REIMAGINE 5, in adults with type 2 diabetes, CagriSema produced 12.4% weight loss at 60 weeks versus 9.1% on tirzepatide 5 mg, with similar A1c reductions. In REDEFINE 9, in adults with obesity or overweight, it produced 21.0% versus 2.0% on placebo at 68 weeks. Both figures use the efficacy estimand and are not yet peer reviewed.
What it means. A decision on the first GLP-1 and amylin combination could come before the end of 2026. Novo’s application, filed December 18, 2025, is for the 2.4 mg/2.4 mg dose.
If you take this or are considering it. As of November 2, 2026, we found no FDA decision, so there is nothing to ask a pharmacy for yet. If you are on semaglutide, CagriSema already contains it, so the question would be whether adding an amylin drug is worth it for you. Read the trial numbers with care. The 21.0% figure comes from a lower dose than the one Novo filed, it assumes people stayed on treatment, and it has not been peer reviewed. The higher dose also fell short against tirzepatide 15 mg. If FDA approves CagriSema, its label will set the dose, the warnings and who it is for.
What has not changed. CagriSema is not approved, and neither is cagrilintide on its own. No public FDA action date has been announced. In the earlier REDEFINE 4 trial, the 2.4 mg/2.4 mg dose did not show non-inferiority to tirzepatide 15 mg for weight loss. The cagrilintide guide has the full results and will record the decision.