Cagrilintide

What It Is

Cagrilintide is a long-acting analog of the hormone amylin, which is naturally co-secreted with insulin from pancreatic beta cells. It works by slowing gastric emptying, promoting satiety, and reducing glucagon secretion. It is the amylin component of CagriSema, a once-weekly fixed-dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg. On December 18, 2025, Novo Nordisk submitted a New Drug Application (NDA) to the FDA for CagriSema for chronic weight management — making it the first GLP-1/amylin combination to reach NDA stage. Both pivotal Phase 3 trials were published in the New England Journal of Medicine in 2026. In REDEFINE-1, CagriSema achieved 20.4% mean weight loss at 68 weeks, with 60% of participants losing ≥20% and 23% losing ≥30% body weight. In REDEFINE-2 (adults with obesity and T2D), CagriSema achieved 13.7% mean weight loss and 73.5% of participants reached HbA1c ≤6.5% vs 15.9% with placebo. Gastrointestinal AEs affected 79.6% of the CagriSema group but were mostly transient and mild-to-moderate. CagriSema initially fell short of an internal 25% weight loss target, which briefly pressured Novo Nordisk's stock price, though the 22.7% on-treatment weight loss still exceeds most competitors. The FDA is expected to render a decision by approximately October 2026 under standard review timelines. In April 2026, Novo Nordisk announced positive headline results from REIMAGINE-2, a Phase 3 trial in adults with overweight or obesity and type 2 diabetes. CagriSema 2.4 mg/2.4 mg demonstrated superior HbA1c reduction of 1.91 percentage points versus 1.76 with semaglutide 2.4 mg alone (from a baseline of 8.2%), and superior weight loss of 14.2% versus 10.2% with semaglutide alone (from a baseline of ~101 kg) at 68 weeks. These results confirm CagriSema's incremental benefit over its GLP-1 component alone in the T2D population.

Proposed Mechanisms

• Activates amylin receptors in the area postrema to reduce appetite and caloric intake
• Slows gastric emptying, prolonging post-meal satiety signals
• Reduces post-prandial glucagon secretion, improving glycemic control
• Complements GLP-1 agonism through an independent anorexigenic pathway
• Long-acting albumin-binding design extends half-life to once-weekly dosing

Evidence Snapshot

Commonly Discussed Benefits

Safety & Cautions

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Citations

1. [1] Novo Nordisk — CagriSema NDA filing announcement. December 2025 PubMed
2. [2] REDEFINE-1 — Cagrilintide-Semaglutide in Adults with Overweight or Obesity, NEJM 2026 PubMed
3. [3] REDEFINE-2 — Cagrilintide-Semaglutide in Adults with T2D, NEJM 2026 PubMed
4. [4] Novo Nordisk submits NDA for CagriSema — PharmExec, April 2026 PubMed
5. [5] Novo Nordisk — REIMAGINE-2 Phase 3 headline results, April 2026 PubMed

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