Research summary
Cagrilintide research
A long-acting acylated amylin analog that complements GLP-1 agonism — being co-developed with GLP-1S (CagriSema) for superior weight loss.
Evidence at a glance
What the research says about Cagrilintide
The Cagrilintide evidence base cited here is 9 sources — 3 clinical, 3 preclinical, 1 review. Its strongest evidence is human — 3 clinical studies, most recently 2025 ("Coadministered Cagrilintide and Semaglutide 2.4 mg in Adults with Obesit…"). Regulatory status: Not FDA-approved (Phase III).
Summary
Key takeaways
- Cagrilintide (AM833) is a long-acting amylin analog — a dual amylin and calcitonin receptor agonist — developed by Novo Nordisk for weight management, on its own and combined with GLP-1S as 'CagriSema'.
- Reported Phase 3 data for CagriSema describe up to ~22.7% weight loss in obesity (REDEFINE 1) and ~15.7% in type 2 diabetes (REDEFINE 2). These are company/topline-stage figures — confirm against the primary publications before relying on them.
- It is not yet commercially available. Projected approval timing (commonly cited as around 2026) is not confirmed and should be verified.
Overview
It is still investigational — not commercially available and not FDA-approved. Several of the figures and timelines below come from company-reported or topline-stage data; where that is the case it is flagged, and those numbers should be confirmed against peer-reviewed publications.
What Is Cagrilintide?
Unlike the GLP-1/GIP/glucagon agonists, cagrilintide works through the amylin pathway, which is why it is complementary to (rather than overlapping with) GLP-1S — the rationale behind the CagriSema combination.
How It Works
Amylin & calcitonin receptor agonism
Cagrilintide activates the amylin and calcitonin receptor complexes that signal satiety and slow gastric emptying. Acting on a different pathway than GLP-1 means it adds an independent satiety signal — the mechanistic basis for combining it with GLP-1S rather than another incretin drug.
Why pair it with GLP-1S
GLP-1 agonism (GLP-1S) and amylin agonism (cagrilintide) suppress appetite through separate routes. Combining them is intended to produce additive weight loss beyond what either achieves alone, which is what the CagriSema trials were designed to test.
Side Effects
- Anti-cagrilintide antibodies develop in a large share of patients (reported in the ~46–73% range), but have not been reported to reduce efficacy
- No clinically significant QT-interval prolongation was seen in a dedicated thorough-QT study
Key Trials (topline / pending verification)
- REDEFINE 1 (Phase 3 obesity): CagriSema reported ~22.7% mean weight loss at 68 weeks vs placebo — reported figure, confirm against the NEJM publication.
- REDEFINE 2 (Phase 3, type 2 diabetes + obesity): reported ~15.7% weight loss with a large share reaching HbA1c targets — reported figure, confirm against publication.
- Foundational PK/pharmacology: Lau et al., J Med Chem 2021 (characterized the lipidated amylin analog and its ~1-week half-life).
REDEFINE-program figures and any 2026 approval timing were reported topline; treat them as provisional until peer-reviewed publication and an actual regulatory decision.
Legal & Status
Cagrilintide is investigational and not approved by the FDA or any regulatory agency; it is not commercially available. Commonly cited approval projections (around 2026) are not confirmed. Research-grade cagrilintide is for laboratory research only and is not intended for human use.
Citations
9 peer-reviewed sources
All citations link to the original source (PubMed, journal site, or regulatory filing). Independent research database — no vendor influence on what's cited.
Clinical3 sources
Preclinical3 sources
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