Cagrilintide
Amylin analog · Novo Nordisk
Top dose
2.4 mg
Weight loss
-11.8%
at week 68 · trial product
AE discontinuation
4.0%
Status
phase 3
Weight loss trajectory #
Pivotal trial #
- Trial
- REDEFINE 1 (mono) / RENEW Ph3
- Indication
- obesity (no T2D)
- Duration
- 68 weeks
- ClinicalTrials.gov
- NCT05567796
- Sponsor
- Novo Nordisk
Notes #
CORRECTED 2026-06-23 (reviewer): NOT discontinued. Phase 3 monotherapy data presented at EASD Sept 2025 - the REDEFINE 1 cagrilintide 2.4 mg monotherapy arm gave -11.8% at 68 wk vs -2.3% placebo (first/only Phase 3 of a long-acting amylin monotherapy). Novo is advancing standalone cagrilintide into a dedicated Phase 3 (RENEW, obesity without comorbidities, starting late 2025). The earlier mono program (Phase 2: Lau Lancet 2021, 4.5 mg -10.8%) was paused for CagriSema but has been revived. ae_disc_pct 4.0% carried from the earlier mono data; the exact REDEFINE 1 mono AE-led discontinuation is not separately captured here.