Type: drug
Status: Active — Pivotal Trials, FDA Submission Expected Late 2026
Developer: Novo Nordisk
CagriSema combines a long-acting amylin analogue (cagrilintide) with semaglutide in a once-weekly injection. Phase 3 REDEFINE trials demonstrate superior HbA1c reduction (-2.2%) and weight loss (-15.6% at 68 weeks) vs semaglutide monotherapy. FDA submission expected late 2026.
Dual mechanism: Cagrilintide mimics amylin (co-secreted with insulin), slowing gastric emptying, reducing glucagon, and enhancing satiety. Semaglutide activates GLP-1 receptors for glucose-dependent insulin release. Combined effect exceeds either agent alone.
Year: 2025-2026