Investigational / not FDA-approved

Cagrilintide

Long-acting amylin analogue (AM833) — investigational monotherapy; CagriSema combo is a separate object.

Editorial review:

What evidence says

Evidence snapshot

This drawer marks papers. It is not a plan, a dose, or a source. A paper is a bounded report. It is not a protocol. Grades name the object. They are not a safety rating.

Identity lock. Cagrilintide (developmental code AM833 / NN0174-0833 class; INN cagrilintide) is a long-acting amylin analogue. PubChem CID 171397054; formula C194H312N54O59S2 / MW ~4409; CAS 1415456-99-3. It has no approved drug indication as monotherapy in the jurisdictions this drawer treats as labeled (US/EU). Off-label does not apply. There is no label to be off of. It is not semaglutide, tirzepatide, liraglutide, or eloralintide. Combination trials with semaglutide (CagriSema / coadministered cagrilintide + semaglutide) are combination objects — they are not single-agent cagrilintide proof. Always name “cagrilintide alone” vs “cagrilintide + semaglutide (CagriSema).”

Bottom line

PubMed holds chemistry/development work, a phase 2 monotherapy weight-management trial, early coadministration PK/PD work, phase 2 CagriSema in type 2 diabetes, and large 2025 coadministered cagrilintide + semaglutide phase 3–style obesity reports (with and without type 2 diabetes). Mark monotherapy vs combo every time. A CagriSema weight paper does not establish single-agent cagrilintide as a labeled product.

Papers

Investigational — chemistry / development

PMID 34288673 — Kruse 2021

Tested: medicinal chemistry and development narrative for cagrilintide as a long-acting amylin analogue.

Does not show: confirmatory phase 3 clinical efficacy by itself, or an approved indication.

Investigational — cagrilintide monotherapy (weight)

PMID 34798060 — Lau 2021

Tested: once-weekly injectable cagrilintide alone versus placebo and versus an active liraglutide control for weight management in people with overweight or obesity (multicentre, randomised, double-blind, dose-finding phase 2).

Does not show: a CagriSema combination claim, a labeled monotherapy indication, or equivalence to eloralintide.

Investigational — combination object (cagrilintide + semaglutide)

PMID 33894838 — Enebo 2021

Tested: safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant multiple doses of cagrilintide with semaglutide for weight management (early clinical coadministration study).

Does not show: single-agent cagrilintide efficacy as in Lau, or a labeled combination product.

PMID 37364590 — Frias 2023

Tested: co-administered once-weekly cagrilintide with once-weekly semaglutide versus comparators in type 2 diabetes (multicentre, randomised, double-blind phase 2 combination object).

Does not show: monotherapy cagrilintide proof, or an obesity-without-diabetes CagriSema phase 3 substitute.

PMID 40544433 — Garvey 2025

Tested: coadministered cagrilintide and semaglutide versus control for body weight in adults with overweight or obesity (combination object; NEJM report).

Does not show: single-agent cagrilintide efficacy, or that the combination equals either component alone for every use.

PMID 40544432 — Davies 2025

Tested: cagrilintide–semaglutide combination versus control in adults with overweight or obesity and type 2 diabetes (combination object; NEJM report).

Does not show: the obesity-without-diabetes Garvey combination object as identical, or monotherapy cagrilintide proof.

PMID 41328546 — Verma 2026

Tested: blood-pressure outcomes with CagriSema in adults with overweight or obesity inside the REDEFINE 1 combination program.

Does not show: a dedicated cardiovascular-outcomes trial for cagrilintide monotherapy, or a labeled hypertension indication.

Secondary synthesis / context

PMID 36883831 — D'Ascanio 2024

Tested: review of cagrilintide as a long-acting amylin analog for obesity.

Does not show: a new primary randomized result, or an approved monotherapy label.

PMID 39676787 — Dutta 2024

Tested: systematic review and meta-analysis of cagrilintide alone and in combination with semaglutide (CagriSema) as anti-obesity medications.

Does not show: a new primary trial; keep monotherapy vs combo strata distinct when reading.

What is not established

An approved cagrilintide monotherapy indication. That CagriSema combination results prove single-agent cagrilintide. Interchangeability with eloralintide (different selective amylin-receptor agonist object) or with GLP-1/GIP products. A non-trial preparation is not the trial cagrilintide or CagriSema material.

Selected sources

34288673 34798060 33894838 37364590 40544433 40544432 41328546 36883831 39676787

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