Metabolic / GLP-1Investigational

Cagrilintide

Also known as: CagriSema (combination)

Phase 3 REDEFINE program evaluating CagriSema (cagrilintide + semaglutide)

Educational content only. This page does not constitute medical advice, diagnosis, or treatment recommendations. Always consult a qualified healthcare professional before making decisions related to any medication or health intervention.

Overview

Cagrilintide is a long-acting synthetic analog of amylin, a peptide hormone co-secreted with insulin from pancreatic beta cells. Amylin plays a role in slowing gastric emptying, promoting satiety, and suppressing glucagon secretion after meals. Cagrilintide is structurally modified to enhance its duration of action and is designed for once-weekly subcutaneous administration.

Cagrilintide is developed by Novo Nordisk and is most prominently studied in combination with semaglutide as a fixed-dose combination known as CagriSema. This combination pairs amylin receptor agonism with GLP-1 receptor agonism, targeting two distinct satiety and metabolic pathways. CagriSema is currently in Phase 3 clinical trials and has not been approved by any regulatory authority.


Research & Clinical Context

Phase 2 data on cagrilintide as a monotherapy showed dose-dependent weight reduction in adults with overweight or obesity. However, the primary clinical interest has centered on the CagriSema combination. In Phase 2 studies comparing CagriSema with cagrilintide alone and semaglutide alone, the combination demonstrated greater weight reduction than either monotherapy.

The REDEFINE Phase 3 program is evaluating CagriSema across multiple indications, including obesity and overweight, type 2 diabetes, and cardiovascular outcomes. A systematic review of GLP-1 drugs found that CagriSema was associated with the most weight reduction among all evaluated GLP-1-class therapies at the time of publication. Phase 3 results are expected in 2025 and 2026.


References


Safety & Regulatory Notes

Cagrilintide (alone and as CagriSema) is investigational and has not been approved by the FDA or any other regulatory authority. It is currently available only through clinical trial enrollment. The adverse event profile observed in Phase 2 studies has been consistent with other incretin and amylin-class therapies, with gastrointestinal symptoms being the most commonly reported.

Regulations vary by country. Readers should consult a licensed healthcare provider for decisions regarding investigational therapies or clinical trial participation.

How This Fits Into Our Peptide Hub

Cagrilintide is featured in our pipeline tracker, primarily in the context of the CagriSema combination. It represents a novel mechanism (amylin agonism) that is distinct from GLP-1 and GIP pathways. It is commonly discussed in comparisons with tirzepatide and retatrutide on our platform.

See Also