(2021), Lancet 397(10286), PubMed 33894838 Statistics from preclinical literature Cagrilintide (development code AM833 ), a long-acting amylin analogue , 32 amino acids, molecular weight 3.795 kDa Developed at Novo Nordisk (Denmark) as part of the CagriSema combination program (cagrilintide + semaglutide) Target: amylin receptors (AMY1, AMY2, AMY3) + secondarily the calcitonin receptor , extended half-life via a C16 fatty acid linker Standard dose in clinical trials: 0.164.5 mg/week subcutaneously (Phase 1b/2) Phase 2 (Enebo 2021, n=96): 17.1 % reduction in body weight with CagriSema 2.4 mg + 2.4 mg over 20 weeks vs 9.8 % with semaglutide alone REDEFINE 1 Phase 3 (2024, preliminary data): 22.7 % weight reduction with CagriSema 2.4 mg/2.4 mg over 68 weeks Status: Phase 3 completed 20242025 , FDA filing expected 20252026 Approximately 25+ peer-reviewed publications in PubMed (20182024) Reference sources (PubMed) Enebo LB

Between 1 March and 19 August 2019, 706 participants were randomised in total , in a 6:1 ratio: approximately 506 to once-weekly subcutaneous cagrilintide at 0.3, 0.6, 1.2, 2.4 or 4.5 mg (100102 per dose group), 99 to once-daily liraglutide 3.0 mg, and 101 to volume-matched placebo
Lyophilised Bacteriostatic Water is stable at -20C long-term
Recording batch numbers allows tracking of any quality variations
MedSole RCM's claim submissions process includes a pre-submission diagnosis pointer audit that catches 837P loop mismatches before they generate CO-16 denials