Cagrilintide
CagriSema (combination)
Cagrilintide is a long-acting amylin analog studied in combination with semaglutide (CagriSema) in Phase 3 REDEFINE trials. It is not yet approved by any regulatory authority.
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 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.
Safety and regulatory framing
Phase 3 REDEFINE program evaluating CagriSema (cagrilintide + semaglutide)
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.
References
- Frias JP, et al. "Efficacy and Safety of Co-administered Once-Weekly Cagrilintide 2.4 mg with Subcutaneous Semaglutide 2.4 mg." Lancet (2023) ↗The Lancet
- ClinicalTrials.gov: REDEFINE Program (CagriSema Phase 3) ↗ClinicalTrials.gov
- Novo Nordisk CagriSema Pipeline Page ↗Novo Nordisk
- Approved and Emerging Hormone-Based Anti-Obesity Medications: A Review. PMC (2024) ↗PMC / NLM
Research information only
Peptide Daily is an informational resource only. Peptide research chemicals are not approved for human use by the FDA unless otherwise noted. Nothing on this site constitutes medical advice. Consult a qualified healthcare provider before using any peptide or research chemical.
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