Weight Loss

Cagrilintide

Also known as: AM833

A long-acting amylin analog studied for weight management, notably in combination with semaglutide (“CagriSema”) — an investigational, non-incretin approach to appetite control.

6 cited sources Status: see guide No dosing advice How we research & review →

Quick facts

Class
Long-acting amylin (and calcitonin) receptor agonist
Studied for
Obesity / weight management
Notable combo
CagriSema (with semaglutide)
Status
Investigational — not yet approved
Drug class
Amylin analog (amylinomimetic)
Administration
Subcutaneous injection, once weekly
Development stage
Phase 3 (as part of CagriSema)
Approval status
Investigational; not approved
Educational summary only — not medical advice. Cagrilintide is not an approved medicine for general use. Evidence is limited and does not establish human safety or efficacy.

Key takeaways

  • Cagrilintide is a long-acting amylin analog designed for once-weekly subcutaneous dosing, mimicking the satiety hormone amylin.
  • It is investigational and not approved by the FDA or EMA for any indication as of early 2026.
  • Its most advanced use is in CagriSema, a fixed combination with the GLP-1 agonist semaglutide being developed by Novo Nordisk for obesity and type 2 diabetes.
  • In trials it reduces appetite and body weight, with combination data suggesting greater weight loss than semaglutide alone.
  • As an injectable peptide, common side effects reported are gastrointestinal, such as nausea, consistent with appetite-suppressing agents.

Overview

Cagrilintide, also known by its development code AM833, is an investigational long-acting analog of the hormone amylin. Amylin is naturally secreted alongside insulin by the pancreas and contributes to regulating appetite, the speed of stomach emptying, and the release of glucagon. Cagrilintide has been engineered for an extended duration of action, supporting once-weekly dosing, and is being studied primarily for its potential in weight management and metabolic health.

It has attracted particular attention as part of a combination product called CagriSema, which pairs cagrilintide with the GLP-1 receptor agonist semaglutide. The rationale is that combining an amylin analog with a GLP-1 agonist may produce complementary effects on appetite and weight beyond what either agent achieves alone. This combination has been a notable focus of clinical research in the obesity field.

Importantly, cagrilintide is not an approved medication. It remains in clinical development, and any data should be interpreted as investigational. It is distinct from approved weight-management therapies, and it is not available as a standard prescription product.

How it works

Cagrilintide acts as an analog of amylin, working through amylin and calcitonin receptors to influence the body's regulation of appetite and energy balance. Native amylin is co-secreted with insulin and helps signal satiety, slows gastric emptying, and suppresses inappropriate glucagon secretion after meals. By mimicking and extending these actions, cagrilintide is intended to reduce food intake and support weight reduction.

A central mechanistic idea behind cagrilintide is that amylin-based signaling is complementary to GLP-1 signaling. The two hormone pathways influence appetite through partly different routes in the brain and gut, so combining an amylin analog with a GLP-1 agonist such as semaglutide may engage multiple appetite-regulating mechanisms simultaneously. This is the basis for the CagriSema combination being studied for greater weight loss than a single pathway might achieve.

Cagrilintide is chemically modified to prolong its presence in the body, allowing once-weekly administration in contrast to the very short-lived natural hormone. While the underlying biology of amylin is well established, the specific long-term effects of sustained amylin-analog signaling in humans are still being defined through ongoing clinical research rather than settled by completed, approved use.

Research & evidence

Cagrilintide has been studied in clinical trials as both a standalone agent and, more prominently, as part of the CagriSema combination with semaglutide. Early and mid-stage studies in the obesity and metabolic field have explored its effects on body weight, and the combination approach has been a significant focus because of interest in whether dual amylin and GLP-1 signaling can enhance weight reduction relative to GLP-1 therapy alone.

The evidence base, while growing, is still that of an investigational compound. Trials are designed to characterize efficacy, dosing, and safety, and results inform ongoing development rather than established clinical practice. Because cagrilintide is not approved, conclusions about its place in therapy remain provisional, and outcomes can differ across trial phases and populations. Readers should be cautious about overinterpreting early data or media coverage as confirmation of a finished, validated treatment.

It is appropriate to acknowledge the CagriSema program by name as a real and actively studied development effort. However, specific numerical results, comparative rankings, and final conclusions are best drawn from the completed, peer-reviewed trial reports as they become available, rather than assumed in advance. The honest summary is that cagrilintide shows scientific promise in obesity research but has not yet reached regulatory approval.

Safety & legal status

As an investigational agent, cagrilintide does not yet have the fully characterized long-term safety profile that accompanies approved medicines. The side effects observed in clinical studies of amylin analogs and related metabolic drugs are predominantly gastrointestinal, including nausea, and such effects are a common theme for agents that slow gastric emptying and reduce appetite. Comprehensive safety conclusions await the completion and review of larger trials.

Because cagrilintide is frequently studied in combination with semaglutide, the safety considerations of the combination also reflect those of GLP-1 receptor agonists. Ongoing clinical research is responsible for determining tolerability, appropriate dosing, and any risks that emerge with sustained use. Until that work is complete and evaluated by regulators, the full risk picture remains provisional.

From a legal standpoint, cagrilintide is not approved by the FDA, the EMA, or other major regulators and is not available as a standard prescription medication. It exists within clinical development programs rather than on the market. Any product claiming to offer cagrilintide outside of a legitimate clinical trial should be regarded with skepticism, as it would fall outside regulated pharmaceutical channels and lack the quality assurances and oversight that approval and proper manufacturing provide.

Frequently asked questions

What is cagrilintide?

Cagrilintide (AM833) is a long-acting synthetic analog of the hormone amylin, developed by Novo Nordisk as an investigational treatment for obesity. Amylin is co-secreted with insulin and contributes to feelings of fullness and slowed gastric emptying.

Is cagrilintide approved?

No. As of early 2026 it remains investigational and has not received marketing approval from any major regulator. It is being studied primarily as part of the CagriSema combination.

What is CagriSema?

CagriSema is a fixed-dose combination of cagrilintide and semaglutide being developed for weight management and type 2 diabetes. It pairs an amylin analog with a GLP-1 receptor agonist to target appetite through complementary mechanisms.

How is cagrilintide given?

In clinical trials it is administered as a once-weekly subcutaneous injection, the same dosing frequency as semaglutide, which supports their use as a combined product.

How does cagrilintide differ from semaglutide?

Cagrilintide acts on amylin receptor pathways, whereas semaglutide is a GLP-1 receptor agonist. They use different but complementary mechanisms to reduce appetite, which is the rationale for combining them.

References

Each source links to its original record — peer-reviewed studies, regulator pages, or reference texts, labelled by type. We summarize findings neutrally; a citation is a reference, not an endorsement, and not a claim that its authors reviewed this page.

  1. Lau DCW, Erichsen L, Francisco AM, et al. Once-weekly cagrilintide for weight management in people with overweight and obesity: a phase 2 trial. Lancet. 2021. Journal article
  2. Enebo LB, Berthelsen KK, Kankam M, et al. Concomitant cagrilintide with semaglutide 2.4 mg for weight management: a randomised, controlled, phase 1b trial. Lancet. 2021. Peer-reviewed study
  3. Garvey WT, Blüher M, Osorto Contreras CK, et al. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2025. Peer-reviewed study
  4. Davies MJ, Bajaj HS, Broholm C, et al. Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes. N Engl J Med. 2025. Peer-reviewed study
  5. Lau DCW, Erichsen L, Francisco AM, et al. Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial. Lancet. 2021. Peer-reviewed study
  6. Frias JP, Deenadayalan S, Erichsen L, et al. Efficacy and safety of co-administered once-weekly cagrilintide 2·4 mg with once-weekly semaglutide 2·4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial. Lancet. 2023. Peer-reviewed study

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