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MetabolicResearch strength: StrongEvidence: Moderate

CagriSema

CagriSema (cagrilintide + semaglutide)

A fixed combination of the amylin analogue cagrilintide and semaglutide that produced about 23% weight loss in Phase 3 and has been filed for FDA approval.

Overview

CagriSema is Novo Nordisk's once-weekly fixed-dose combination of cagrilintide, a long-acting amylin agonist, and semaglutide, a GLP-1 agonist. Combining the two appetite pathways produced roughly 22.7% mean weight loss at 68 weeks in the REDEFINE 1 trial by the trial-product estimand (20.4% versus 3.0% for placebo in the NEJM treatment-policy analysis), ahead of semaglutide alone. It has been filed with the FDA for weight management and is expected to be a leading next-generation obesity therapy. Update, September 2026: Novo Nordisk submitted the FDA application in December 2025; a decision is expected in 2026.

Mechanism of action

Simultaneously agonizes amylin receptors (satiety) and the GLP-1 receptor (appetite, insulin, gastric emptying) for additive weight loss.

Key studies & citations

  • Human2025

    Coadministered cagrilintide and semaglutide in adults with overweight or obesity (REDEFINE 1)

    3,417 adults: 20.4% weight loss at 68 weeks versus 3.0% with placebo (treatment-policy estimand); 22.7% by trial-product estimand.

    New England Journal of Medicine
  • Human2025

    Cagrilintide-semaglutide in adults with overweight or obesity and type 2 diabetes (REDEFINE 2)

    1,206 patients with type 2 diabetes: 13.7% weight loss at 68 weeks versus 3.4% with placebo.

    New England Journal of Medicine
  • Human2025

    Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP-1 and amylin analogues for weight management

    NDA submitted December 18, 2025 based on REDEFINE 1 and 2; 91.9% of CagriSema participants lost at least 5%.

    Novo Nordisk press release

Frequently asked questions

Is CagriSema approved?

Not yet. It has been filed with the FDA for weight management after strong Phase 3 results, but it is still investigational.

Latest reading on CagriSema

Articles from the blog that cover CagriSema, newest first.

Related compounds

CagrilintideSemaglutideAmycretin