Evidence memo / Metabolic & weight

Cagrilintide

Also: AM833 · long-acting amylin analog

Cagrilintide is a long-acting amylin analog being developed for obesity, on its own and as part of the CagriSema combination with semaglutide. It is investigational and not approved. Phase 2 studies have tested its weight effects, with larger combination trials underway. The Watchlist boundary is keeping it to its investigational obesity program and separating standalone cagrilintide from the CagriSema combination.

Controlled human dataPhase 2 / Phase 3InvestigationalSafety / regulatory watch

The verdict

Our read at a glance.

Whether cagrilintide's early obesity data, alone and in combination, hold up in larger trials and lead to approval.

The signal
Phase 2 trials suggest cagrilintide produces weight loss in obesity, and it is being combined with semaglutide as CagriSema in late-stage programs. As an investigational drug, its full efficacy and safety remain to be established.
The unknown
How its weight effect and tolerability compare with GLP-1 and dual-agonist drugs, and whether the standalone or combination path leads to approval.
Our read
An investigational amylin drug for obesity, not yet proven or approved. Cagrilintide's early data are encouraging, but until late-stage results and any approval it should be read as investigational, and standalone use should not be conflated with the CagriSema combination.

The mechanism

How it works.

Cagrilintide is a long-acting analog of amylin, the pancreatic hormone co-secreted with insulin that signals fullness. It binds amylin receptors in the brainstem to slow gastric emptying and reduce appetite, so people eat less and lose weight, and chemical modifications extend its action to allow weekly dosing. This appetite biology is well established for native amylin, but cagrilintide itself is investigational and not yet approved, on its own or as part of the CagriSema combination with semaglutide.

Safety & regulatory boundary

The consequential part.

Cagrilintide is investigational and not an approved product. Its safety profile, including gastrointestinal effects common to incretin and amylin drugs, is still being characterized in trials. Standalone cagrilintide is not the same as the CagriSema combination, and research-labeled or compounded cagrilintide is not an approved product. Its development status does not support use outside trials.

What's next

What we're watching.

Phase 3 results for CagriSema, standalone cagrilintide data, regulatory filings, and head-to-head comparisons with other obesity drugs.

Context

Why this is discussed.

Cagrilintide is a leading example of the amylin pathway returning to obesity drug development, often discussed alongside the GLP-1 and dual-agonist drugs.

The evidence base

20 cited references.

Registered trials8

Indexed literature (PubMed)12

Weight management treatment in obesity

Rubio-Herrera MA et al. · Med Clin (Barc) · 2025

Keep reading

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