Cagrilintide

What it is

Cagrilintide (AM833) is a long-acting amylin analog developed by Novo Nordisk. Amylin is a peptide hormone co-secreted with insulin from pancreatic beta cells, with physiologic roles in satiety, gastric emptying, and glucagon suppression. Cagrilintide has been studied alone and in combination with semaglutide (CagriSema) in weight-management trials. Cagrilintide is not FDA-approved for any use in the United States.

Mechanism of action

Proposed mechanisms come from laboratory, animal, and human pharmacology research. Amylin receptor activation has been reported to be associated with:

• Slowed gastric emptying
• Changes in satiety and meal size
• Glucagon suppression
• Changes in food-reward signaling

Researchers have hypothesized that amylin signaling acts on pathways distinct from GLP-1 signaling, which is the rationale for studying the combination with semaglutide.

Clinical evidence

Manufacturer-sponsored Phase III trials of the CagriSema combination (cagrilintide + semaglutide) and earlier trials of cagrilintide alone have been published; benefit has not been established by the FDA. These findings come from manufacturer-sponsored trials, and long-term safety data are limited. Novo Nordisk submitted CagriSema to the FDA for review in December 2025; cagrilintide is not FDA-approved as a standalone drug.

Why we don’t prescribe it at The Tide

The Tide does not prescribe cagrilintide or CagriSema.

Side effects and contraindications

Human safety has not been established by the FDA, and long-term effects are unknown. In clinical trials, reported adverse effects were mainly gastrointestinal (such as nausea, vomiting, and constipation), similar to other incretin-related therapies. Products sold outside regulated channels (e.g., “research peptides”) may vary in purity, dose, and sterility.