CagriSema

also known as: cagrilintide/semaglutide 2.4/2.4, NN9838

Novo Nordisk's next-generation obesity injection — NDA filed December 2025, FDA review expected 2026. If approved, it would be the first GLP-1 + amylin fixed-dose combination and a direct competitive response to tirzepatide.

A once-weekly fixed-dose subcutaneous combination of semaglutide 2.4 mg (GLP-1 receptor agonist, the active ingredient in Wegovy) with cagrilintide 2.4 mg (a long-acting amylin analog), submitted by Novo Nordisk to the FDA as a New Drug Application on December 18, 2025 for chronic weight management in adults with obesity or overweight with at least one weight-related comorbidity.

Mechanism of action

Dual-mechanism appetite suppression and weight loss. Semaglutide activates the GLP-1 receptor, slowing gastric emptying, suppressing glucagon, and acting centrally on hypothalamic appetite circuits. Cagrilintide activates amylin and calcitonin receptors (amylin is co-secreted with insulin from pancreatic beta cells), which independently reduce food intake, enhance satiety, and appear to restore leptin sensitivity. Combining the two mechanisms produces additive-to-synergistic weight loss in clinical trials.

Primary uses

Chronic weight management in adults with obesity (BMI ≥30) or overweight (BMI ≥27) with at least one comorbidity (investigational)
Not yet approved for any use

Typical dosing

2.4 / 2.4 mg once weekly (subcutaneous)

Investigational regimen from REDEFINE 1. Dose titration protocol mirrors semaglutide up-titration.

Regulatory status

NDA submitted to FDA December 18, 2025 based on the REDEFINE 1 Phase 3 trial. Novo Nordisk developer. FDA review expected 2026. In REDEFINE 1 (68 weeks, 3,417 adults with obesity or overweight), CagriSema produced approximately 23% mean body weight reduction under the trial-product estimand and approximately 20.4% under the treatment-policy estimand, versus ~3% for placebo.

References

[news-release] Novo Nordisk. "Novo Nordisk Files for FDA Approval of CagriSema, the First Once-Weekly Combination of GLP-1 and Amylin Analogues for Weight Management." December 18, 2025.
[clinical-trial] REDEFINE 1 Phase 3 trial (68 weeks, 3,417 participants). Novo Nordisk. 2025. Results released December 2024 / 2025.

Related peptides

Semaglutide

A once-weekly GLP-1 receptor agonist FDA-approved for type 2 diabetes and chronic weight management.

Cagrilintide

A once-weekly amylin analog developed primarily as a combination partner for semaglutide (CagriSema), adding amylin-pathway appetite suppression to GLP-1 activity.

Tirzepatide

A once-weekly GLP-1/GIP dual agonist that produced unprecedented weight loss in SURMOUNT trials — up to ~21% at highest dose.

Petrelintide

Zealand Pharma's amylin monotherapy — ZUPREME-1 Phase 2b hit its endpoints in March 2026 with up to 10.7% weight loss at 42 weeks and "placebo-like" GI tolerability. Roche-partnered since 2025; Phase 3 planned for late 2026.

Disclaimer

This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.