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Educational reference only. Nothing on this page constitutes medical advice or encourages personal use of this compound. Always consult a qualified healthcare provider before any decision involving your health.

Cagrilintide

Cagrilintide · Amylin Analog

C
Animal replicated
Research chemicalAmylin AnalogCalcitonin Receptor AgonistPeptide
RouteInjectableGray-market only
C
Evidence grade: Animal replicated

Effect demonstrated in multiple animal studies; human data sparse or extrapolated. Grades summarize evidence quality, not whether a compound is appropriate, legal, or risk-free.

At a glance
What it is
INN: Cagrilintide — Long-Acting Amylin Analogue / Dual Amylin-Calcitonin Receptor Agonist — Amylin Analog, Calcitonin Receptor Agonist, Peptide.
Why people use it
Used primarily for weight loss and gut health.
What the evidence supports
Cagrilintide occupies a unique regulatory position among all compounds in this reference: it is not a research chemical with indefinite unknowns, but a pharmaceutical days-to-months from FDA approval whose community use is running slightly ahead of the approval timeline.
If you only read one thing

Cagrilintide is the most clinically advanced compound in this reference — a Phase 3-completed, NEJM-published, Novo Nordisk-developed pharmaceutical that is weeks to months away from FDA approval as of mid-2026. The Phase 3 REDEFINE 1 trial combining cagrilintide with semaglutide produced 22.7% average body weight loss at 68 weeks — one of the highest weight loss figures ever reported in a randomized clinical trial of obesity medication. Cagrilintide monotherapy produces 11.8% weight loss through an entirely different mechanism than GLP-1. The compound represents the first genuinely new mechanism to emerge in obesity pharmacology since GLP-1: amylin receptor activation from a complementary brainstem circuit. Community members are self-administering it as a research chemical in advance of its FDA approval — running ahead of the pharmaceutical timeline by months rather than years. The safety profile appears favorable; the primary concern (calcitonin receptor → MTC risk) is a class effect shared with GLP-1 agents. The benefit-risk ratio for community use in the window before FDA approval is different from other research chemicals in this reference — this compound has completed Phase 3 and the FDA is reviewing it.

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Published literature
3human RCTs0human studies1animal0in vitro

Counts include REDEFINE 1, REDEFINE 2, and the cagrilintide monotherapy sub-analysis/arm as positive controlled human evidence; animal count captures supporting AMY1R/AMY3R mechanism work.

Evidence reality check
Human evidence
3 human studies
3 randomized; 0 observational.
Preclinical base
1 lab signal
1 animal; 0 in-vitro/mechanistic.
Evidence snapshot
Cagrilintide occupies a unique regulatory position among all compounds in this reference: it is not a research chemical with indefinite unknowns, but a pharmaceutical days-to-months from FDA approval whose community use is running slightly ahead of the approval timeline.
From the chapter quick-reference block.
Categories
Weight Loss & MetabolicGut & Digestive
Properties
Active malignancy: caution✓ Human RCT
Evidence
CAnimal replicated
Amylin Biology — The Missing Hormone
Amylin (IAPP) is co-secreted with insulin by pancreatic β-cells in response to meals. Its natural roles: (1) satiety signaling via area postrema and nucleus tractus solitarius in the brainstem; (2) slowing of gastric emptying; (3) suppression of postprandial glucagon; (4) reduction of hepatic glucose output. Amylin is deficient in type 1 diabetes (where β-cells are destroyed) and reduced in type 2 diabetes (where β-cell function declines). Pramlintide (Symlin) — the first amylin analogue — was FDA-approved in 2005 but required TID injection with every meal, limiting uptake. Cagrilintide is a once-weekly formulation addressing this practical obstacle.
The REDEFINE 1 Trial — The Landmark Data
REDEFINE 1 (Garvey et al., NEJM, June 22, 2025): n=3,417 adults without T2D; BMI ≥27 with ≥1 weight-related comorbidity; 68 weeks; 4-arm design: CagriSema vs cagrilintide alone vs semaglutide alone vs placebo. PRIMARY RESULTS: CagriSema (on-treatment): -22.7% body weight; semaglutide alone: -14.9%; cagrilintide alone: -11.5%; placebo: -3.0%. 40.4% of CagriSema participants achieved ≥25% weight loss; 20% achieved ≥30%. True synergy: 22.7% exceeds what either component would produce alone. Published NEJM simultaneously with ADA 2025 presentation.
CagriSema — The Combination
CagriSema = fixed-dose combination of cagrilintide 2.4mg + semaglutide 2.4mg, once weekly subcutaneous injection. The two compounds act through completely different receptor systems: amylin receptors (AMY1R/AMY3R) vs GLP-1 receptors — no overlap. The brain regions activated also overlap but are distinct: amylin primarily targets area postrema and NTS; GLP-1 primarily targets hypothalamus, NTS, and vagal pathways. The combination produces synergistic rather than merely additive weight loss (22.7% > 14.9% + 11.5% minus overlap). CagriSema NDA filing Q1 2026; anticipated approval late 2026/early 2027.
Cagrilintide Monotherapy — REDEFINE Sub-analysis + RENEW Program
Cagrilintide monotherapy (2.4mg/week): REDEFINE 1 sub-analysis presented at EASD September 2025 — 11.8% body weight reduction vs 2.3% placebo at 68 weeks; 31.6% achieved ≥15% weight loss; 1.0% discontinued. This is significant for the community: cagrilintide monotherapy produces clinically meaningful weight loss through a completely different mechanism than GLP-1 agents, with a different side effect profile (lower GI side effect rate than GLP-1 agents). RENEW program (dedicated Phase 3 for cagrilintide monotherapy) started Q4 2025 for potential separate monotherapy approval.
The Calcitonin/MTC Safety Concern
Cagrilintide acts at calcitonin receptors (CTR) in addition to amylin receptors. CTR agonism raises a class concern that applies to all calcitonin receptor agonists: rodent studies with calcitonin receptor agonists show C-cell hyperplasia and medullary thyroid carcinoma (MTC). This is the same class concern that applies to GLP-1 receptor agonists (which also activate calcitonin-related signaling indirectly) and is the basis for GLP-1 agonist black box warnings regarding MTC. For cagrilintide: the CTR-mediated thyroid C-cell concern applies; patients with personal or family history of MTC or MEN2 should not use cagrilintide; this is an expected class effect, not compound-specific.
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