Cagrilintide
Metabolic Health · Amylin analog
Tier B
Bottom line
Read Off Label grades Cagrilintide as B (6.8/10) based on strong evidence, high benefit magnitude, and a med-risk safety profile.
REDEFINE 1 (Garvey NEJM 2025): CagriSema 2.
Typical use: 2. — Investigational; CagriSema NDA filed with FDA Dec 18, 2025.
What this is
REDEFINE 1 (Garvey NEJM 2025): CagriSema 2.4mg/2.4mg achieved -20.4% body weight at 68 weeks vs -3.0% placebo (n=3417, no T2D). Notably below the ~25% projected from Phase 2 — Novo stock fell at the December 2024 readout. Cagrilintide alone -11.5%. REDEFINE 2 (T2D, n=1206): -13.7% vs -3.4% placebo at 68 weeks. REDEFINE 1 BP analysis (Hypertension 2025): -10.9 mmHg SBP. Falls slightly short of tirzepatide 15mg (-22.5% in SURMOUNT-1); head-to-head not yet done. Novo Nordisk filed the CagriSema NDA with the FDA on Dec 18, 2025; an approval decision is expected around October 2026.
Mechanism
Long-acting amylin analog; reduces gastric emptying and food intake via CGRP/amylin receptors in brainstem; synergistic with GLP-1 agonists
Dose & route
2.4 mg SC weekly (monotherapy); CagriSema = cagrilintide 2.4 mg + semaglutide 2.4 mg combo SC weekly
Citations
- https://doi.org/10.1056/NEJMoa2502081
- https://doi.org/10.1056/NEJMoa2502082
- https://doi.org/10.1161/HYPERTENSIONAHA.125.26055
- https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01751-7/fulltext
- https://pubmed.ncbi.nlm.nih.gov/41344603/
- https://clinicaltrials.gov/study/NCT07184086
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Common questions
- Does Cagrilintide work?
- Read Off Label rates the evidence for Cagrilintide as Strong and the benefit magnitude as high, producing an overall grade of B (6.8/10). REDEFINE 1 (Garvey NEJM 2025): CagriSema 2.
- Is Cagrilintide safe?
- Cagrilintide has a med risk profile in published human data. Legal status: Investigational; CagriSema NDA filed with FDA Dec 18, 2025 (decision expected ~Oct 2026). This is not medical advice — see the disclaimer.
- What is the typical dose for Cagrilintide?
- 2.4 mg SC weekly (monotherapy); CagriSema = cagrilintide 2.4 mg + semaglutide 2.4 mg combo SC weekly
- How does Cagrilintide work?
- Long-acting amylin analog; reduces gastric emptying and food intake via CGRP/amylin receptors in brainstem; synergistic with GLP-1 agonists
This is an independent synthesis of published research by a non-clinician. Scores are opinions supported by citations, not prescriptions. See the full disclaimer and methodology for how this score was produced and what it does and doesn't mean.