Rankings / Metabolic Health

Cagrilintide

Metabolic Health · Amylin analog

Tier B

Reviewed by Read Off Label · Last reviewed · How we grade

glp-1amylininvestigationalawaiting-readout
6.8 / 10
Tier B
Ev 8 Bn 8 Sf 5

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.

Studied, labeled, or reported-use context: 2. — Investigational; CagriSema NDA filed with FDA Dec 18, 2025; not individualized guidance.

What the evidence says

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. REIMAGINE 2 (Lancet Diabetes & Endocrinology 2026, n=2,713, T2D): cagrilintide-semaglutide (2.4mg/2.4mg) achieved significantly greater HbA1c reduction than semaglutide 2.4mg monotherapy (-1.91 vs -1.75 percentage points, p=0.0035) -- the first head-to-head trial confirming a combination benefit over GLP-1 monotherapy on glycemic control.

Mechanism

Long-acting amylin analog; reduces gastric emptying and food intake via CGRP/amylin receptors in brainstem; synergistic with GLP-1 agonists

Studied, labeled, or reported dose & route

2.4 mg SC weekly (monotherapy); CagriSema = cagrilintide 2.4 mg + semaglutide 2.4 mg combo SC weekly

This records doses and routes described in studies, approved labeling, clinical practice, or documented use. It is not individualized guidance and does not establish safety; context changes with indication, formulation, health history, monitoring, and other medicines.

Citations

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Common questions

What does the evidence show about Cagrilintide's effects?
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.
What safety findings are reported for Cagrilintide?
Cagrilintide has a med risk profile in the database. Med (similar GI profile to semaglutide; nausea/vomiting/diarrhea common) Legal status: Investigational; CagriSema NDA filed with FDA Dec 18, 2025 (decision expected ~Oct 2026).
What doses or routes are reported for Cagrilintide?
2.4 mg SC weekly (monotherapy); CagriSema = cagrilintide 2.4 mg + semaglutide 2.4 mg combo SC weekly This is context from studies, approved labeling, clinical practice, or documented use; it is not individualized guidance and does not establish safety.
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.