CagriSema

GLP-1 + amylin combination (semaglutide 2.4mg + cagrilintide 2.4mg) · Novo Nordisk

Top dose
2.4 / 2.4 mg
Weight loss
-20.4%
at week 68 · treatment policy
AE discontinuation
5.9%
Status
filed

Weight loss trajectory #

Weight loss trajectory for CagriSema 2.4 / 2.4 mg over 68 weeks in the REDEFINE-1 trial.

Pivotal trial #

Trial
REDEFINE-1
Indication
obesity (no T2D)
Duration
68 weeks
ClinicalTrials.gov
NCT05567796
Sponsor
Novo Nordisk

Notes #

REDEFINE-1 obesity (Garvey NEJM 2025, NEJMoa2502081) headline -20.4%, AE-led disc 5.9% vs 3.6% placebo (Table 3, verified against the primary paper). NDA filed Dec 18, 2025; PDUFA ~Oct 2026. REDEFINE 2 (Davies NEJM 2025, obesity + T2D, n=1206) showed -13.7% (treatment-policy) at wk 68 - lower than REDEFINE-1's obesity-only -20.4% as expected for T2D population. REDEFINE-3 CVOT readout H2 2027.