Cagrilintide
10mg · ≥99.4% Purity
Transparency
Certificate of Analysis
Every batch independently verified by third-party laboratories.
Batch #TL-2503
Analytical Formulations Inc.
All Trident Labs products are independently tested by accredited third-party laboratories. Results are batch-specific and provided for research transparency only. This product is not approved for human use.
The amylin pathway. A distinct mechanism under investigation.
Cagrilintide is a synthetic, long-acting analog of human amylin — a pancreatic peptide that targets satiety pathways entirely independent of the GLP-1 axis. As the foundational component of CagriSema, examined in peer-reviewed Phase 3 literature (REDEFINE program, N=3,417). All data sourced from independent published research.
Garvey et al. REDEFINE 1 EASD 2025 · Garvey et al. N Engl J Med 2025;393:635–647. All data from peer-reviewed literature. For Research Use Only — Not for Human Consumption.
Published Research Data
A distinct pathway.
Published results.
Cagrilintide operates through the amylin receptor system — mechanistically independent of GLP-1. All data from independent peer-reviewed literature and clinical trial registrations. Not Trident Labs claims.
11.8%
Mean body weight change observed at 68 wks, cagrilintide 2.4 mg monotherapy vs placebo in REDEFINE 1 Phase 3.
Garvey et al., EASD 2025 · Research findings
22.7%
Mean BW change observed in REDEFINE 1 when coadministered with semaglutide (CagriSema) at 68 weeks.
Garvey et al., NEJM 2025 · Research findings
60%
Proportion of CagriSema-treated participants achieving ≥20% BW reduction in REDEFINE 1 (vs 9% placebo).
REDEFINE 1 Phase 3 · NEJM 2025
3,417
REDEFINE 1 enrollment across arms, without T2D. Largest amylin analog Phase 3 dataset published to date.
NCT04982575 · REDEFINE 1
Dose-Response: Monotherapy BW Change
REDEFINE 1 sub-analysis · % change from baseline at 68 weeks, cagrilintide vs placebo
REDEFINE 1 Phase 3 sub-analysis · Garvey et al., EASD 2025. In vitro research data. Research use only.
Mechanism of Action
Amylin receptor.
Not GLP-1.
Cagrilintide is a dual amylin-calcitonin receptor (DACRA) agonist — the only compound in current Phase 3 research that targets the amylin receptor complex (CTR+RAMP heterodimer) rather than the incretin axis. This makes it mechanistically orthogonal to all GLP-1 class agents.
Amylin Receptor Complex (AMY1R / AMY3R)
Hypothalamic satiety · Gastric emptying modulation · Glucagon suppression · Body composition
CTR + RAMP1/3
GLP-1 Receptor (GLP-1R)
Not engaged — cagrilintide has no GLP-1R activity. Mechanistically orthogonal to semaglutide and tirzepatide.
>10,000 nM
GIP Receptor (GIPR)
Not engaged — distinguishes cagrilintide from tirzepatide's dual incretin approach
>10,000 nM
What makes amylin receptor research distinct
Because cagrilintide engages exclusively the amylin receptor complex, any observed downstream effect in a preclinical model is attributable to that pathway alone. When combined with semaglutide, each component's contribution can be isolated. This orthogonality is a key scientific property that makes cagrilintide a useful in vitro research tool for dissecting amylin vs. GLP-1 pathway contributions to energy metabolism and appetite.
Amylin receptor signaling cascade
AMY1R/AMY3R Binding & Heterodimer Activation
Cagrilintide binds the amylin receptor complex — a heterodimer of the calcitonin receptor (CTR) and RAMP1 or RAMP3. The Aib substitution at position 8 confers DPP-IV resistance. C18 fatty diacid enables albumin binding and ~168 hr half-life.
Gs Coupling & cAMP Elevation
AMY1R/3R couples to Gs protein, elevating intracellular cAMP in neurons of the area postrema, nucleus tractus solitarius, and hypothalamic arcuate nucleus — the primary satiety integration centers.
Hypothalamic Appetite Suppression
cAMP activates POMC/CART neurons in the arcuate nucleus while inhibiting NPY/AgRP pathways — the same downstream targets as GLP-1R, but reached via an independent upstream receptor.
Gastric Emptying & Glucagon Suppression
Peripheral amylin receptor activation slows gastric emptying via vagal afferents, prolonging postprandial satiety. Concurrently, glucagon secretion from pancreatic alpha cells is suppressed in a glucose-independent manner.
Body Composition Effects
Preclinical data suggest cagrilintide preserves lean mass relative to fat mass — a distinction from GLP-1 monotherapy. Energy expenditure is maintained. PMC 2025 (Roed et al.) confirmed AMY1R and AMY3R receptor dependence of these effects in RAMP1/3 KO mice.
D'Ascanio et al. Cardiol Rev 2024 · Roed et al. PMC 2025 · Garvey et al. NEJM 2025. Research use only.
Molecular Architecture
37 residues.
Amylin backbone.
Cagrilintide's 37-amino acid backbone drawn residue-by-residue. Built on the human amylin sequence with three key engineering modifications: Aib8 (DPP-IV resistance), C18 acylation (albumin binding / half-life extension), and disulfide bond preservation at Cys2-Cys7 (receptor specificity).
Compound Comparison
Where AMY-1CA fits.
Cagrilintide is the only Phase 3 compound engaging the amylin receptor — not the GLP-1 or GIP axis. All data from independent published peer-reviewed literature. Trial designs, populations, and durations differ.
Scroll to see full table
%BW = mean change from baseline, highest studied dose, published peer-reviewed trials. *CagriSema combination data (REDEFINE 1). Trial designs, populations, and durations differ significantly across compounds. Not a comparative effectiveness claim. All data from independent published literature. For Research Use Only — Not for Human Consumption.
Receptor Selectivity Profile
Amylin-only.
No incretin activity.
Cagrilintide's receptor selectivity profile vs GLP-1 monoagonist (semaglutide) and dual agonist (tirzepatide). The defining feature is exclusive AMY1R/3R engagement with zero activity at GLP-1R or GIPR — making it the only compound with this profile in Phase 3. EC data from D'Ascanio et al. Cardiol Rev 2024.
D'Ascanio et al. Cardiol Rev 2024 · Lau et al. J Med Chem 2015 · Willard et al. JCI Insight 2020. In vitro data only. Research use only.
Pharmacokinetic Profile
~168-hour half-life.
C18 albumin binding.
Cagrilintide achieves a ~168-hour plasma half-life via C18 fatty diacid albumin binding — identical strategy to semaglutide, enabling once-weekly research dosing. DPP-IV resistance via Aib substitution prevents rapid N-terminal cleavage of the native amylin sequence.
Compound Profile
Full specification
Molecular and pharmacological data from peer-reviewed literature and Trident Labs batch records. Amylin backbone with three engineering modifications for long-acting DACRA activity.
| Common Name | Cagrilintide |
| Code | NNC0174-0833 |
| Class | Dual Amylin-Calcitonin Receptor Agonist (DACRA) |
| Structure | 37-amino acid acylated amylin analogue |
| Mol. Weight | ~4.0 kDa |
| Receptor Targets | AMY1R (CTR+RAMP1) · AMY3R (CTR+RAMP3) |
| GLP-1R / GIPR | No activity — mechanistically orthogonal to incretins |
| Plasma Half-Life | ~168 hours via C18 fatty diacid albumin binding |
| DPP-IV Resistance | Aib substitution at position 8 |
| Disulfide Bond | Cys2–Cys7 disulfide preserved — critical for AMY1R specificity |
| Developer | Novo Nordisk A/S |
| Clinical Stage | Phase 3 · RENEWNDA Filed (CagriSema) Dec 2025 |
| Purity | ≥99% HPLC — 6-panel COA every batch |
| Form | Lyophilized powder · sealed vial |
| Regulatory | Research Use Only — Not for Human Consumption |
Receptor Binding Profile
Relative binding activity from published in vitro data. Research use only.
D'Ascanio et al. Cardiol Rev 2024 · Roed et al. PMC 2025. In vitro cAMP assay data. Research use only.
Aib8 Substitution — DPP-IV Resistance
Alpha-aminoisobutyric acid at position 8 blocks DPP-IV cleavage of the native amylin sequence. Native amylin has a plasma half-life of ~2 minutes; this single substitution is the foundation of cagrilintide's extended pharmacokinetics.
C18 Fatty Diacid — Albumin Binding
A C18 fatty diacid chain creates reversible albumin binding, extending plasma half-life from ~2 minutes (native amylin) to ~168 hours — enabling once-weekly research dosing. Same half-life extension strategy as semaglutide.
Cys2–Cys7 Disulfide Bond Preserved
The native amylin disulfide bridge between positions 2 and 7 is preserved in cagrilintide. This ring structure is required for AMY1R/3R specificity and distinguishes it from calcitonin receptor agonists that lack the amylin-like N-terminal loop.
Research Timeline
Phase 3 active.
NDA filed.
Cagrilintide has moved from Phase 2 proof-of-concept to Phase 3 monotherapy and combination trials within four years. Timeline sourced from published literature and official trial registrations.
Key Research Observations
Cagrilintide 2.4 mg monotherapy: −11.8% mean BW change at 68 weeks vs −2.3% placebo in REDEFINE 1 Phase 3 sub-analysis (N=subset). Only 1.0% of participants discontinued due to nausea — lower than published GLP-1 discontinuation rates.
Garvey et al., EASD 2025 · REDEFINE 1 sub-analysis
CagriSema (cagrilintide + semaglutide): −22.7% mean BW change at 68 weeks in REDEFINE 1 (N=3,417). 99.4% of participants achieved ≥5% BW reduction vs 31.5% placebo. Over 50% reached BMI below obesity threshold vs 10.2% placebo.
Garvey et al., NEJM 2025;393:635–647
AMY1R and AMY3R receptor dependence of cagrilintide's weight loss effects confirmed in RAMP1/3 KO mouse study. Lean mass preservation and maintained energy expenditure observed in preclinical models — mechanistically distinct from GLP-1 monotherapy.
Roed et al., PMC 2025
NDA filed December 18, 2025 for CagriSema (cagrilintide 2.4 mg + semaglutide 2.4 mg). If approved, would become the first injectable amylin + GLP-1 combination. FDA review expected 2026–2027. RENEW program (standalone cagrilintide) initiated Q4 2025.
Novo Nordisk press release, December 18, 2025
RENEW Phase 3 & NDA Review
RENEW Phase 3 programme for standalone cagrilintide initiated Q4 2025. CagriSema NDA under FDA review — decision expected 2026–2027. REDEFINE 3 (CV outcomes) and REIMAGINE (T2D) ongoing.
CagriSema NDA Submitted to FDA
Novo Nordisk files NDA for CagriSema (cagrilintide 2.4 mg + semaglutide 2.4 mg). Based on REDEFINE 1 and REDEFINE 2 Phase 3 data. If approved, would be the first amylin+GLP-1 combination approved.
First Phase 3 Monotherapy Data Published
REDEFINE 1 sub-analysis presented at EASD congress in Vienna: cagrilintide 2.4 mg monotherapy −11.8% BW at 68 weeks. Lowest nausea discontinuation (1.0%) of any amylin-class agent. Triggers RENEW programme launch.
REDEFINE 1 Results — Garvey et al. NEJM 2025
N Engl J Med 2025;393:635–647. CagriSema 22.7% mean BW change (treatment effect analysis) vs 14.9% semaglutide monotherapy at 68 weeks. 60% achieving ≥20% BW reduction.
REDEFINE 2 Completes & REDEFINE 3 Launches
REDEFINE 2 in T2D patients (N=1,206): CagriSema −13.7% BW at 68 weeks. REDEFINE 3 cardiovascular outcomes trial initiated. D'Ascanio et al. Cardiol Rev structural characterization published.
Phase 2 Proof-of-Concept & REDEFINE Launch
Phase 2 CagriSema: 15.6% BW reduction vs 5.1% semaglutide alone (Aug 2022). REDEFINE Phase 3 program initiated. Coskun et al. structural characterization in J Med Chem confirming DACRA pharmacology.
Storage & Laboratory Handling
Maintain sample
integrity.
~4.0 kDa acylated amylin analog. C18 fatty diacid stable under lyophilized storage; susceptible to aggregation on freeze-thaw after reconstitution. The Cys2–Cys7 disulfide bond is sensitive to oxidizing conditions.
Long-term
−20°C
Lyophilized, sealed. Stable 24 months. Protect from light. Avoid frost-free cycling.
Post-reconstitution
2–8°C
Transfer immediately to refrigerator. Do not freeze — C18 acylation susceptible to aggregation on freeze-thaw.
Reconstitution
BAC H2O
2 mL bacteriostatic water via calibrated laboratory syringe. Direct along interior vial wall slowly.
Critical avoids
Avoid
No vortex, shaking, or oxidizing agents — disulfide bond sensitive. Discard if cloudy or particulate.
Laboratory Reconstitution Reference
Standard laboratory procedure for qualified researchers. In vitro research use only.
Equilibrate to ambient laboratory temperature
Remove from −20°C and allow to equilibrate for 15–20 minutes. Do not apply external heat. Prevents condensation and thermal shock to the disulfide bridge.
Add bacteriostatic water
Using a calibrated laboratory syringe, draw 2 mL bacteriostatic water (0.9% benzyl alcohol preferred). Direct solvent slowly along the interior glass wall — not onto the lyophilized cake.
Roll gently to dissolve
Roll vial slowly between palms for 30–60 seconds. Do not vortex — the Cys2–Cys7 disulfide bond makes cagrilintide susceptible to mechanical stress-induced aggregation. Solution should be clear.
Inspect visually
Solution should be clear to slightly opalescent, colorless. Discard if cloudy, particulate, or discolored — may indicate disulfide oxidation or peptide aggregation.
Label and refrigerate
Label with compound name, lot number, and reconstitution date. Transfer immediately to 2–8°C. Do not freeze reconstituted material.
Published Literature
Indexed research on Cagrilintide.
Independent peer-reviewed studies. Not Trident Labs claims. For Research Use Only.
Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity — REDEFINE 1
68-week Phase 3 RCT in 3,417 adults with obesity (BMI ≥30) or overweight with ≥1 comorbidity, without T2D. CagriSema (2.4+2.4 mg/wk) vs cagrilintide 2.4 mg, semaglutide 2.4 mg, or placebo. CagriSema mean BW change −20.4% (treatment policy estimand) or −22.7% (treatment effect estimand) at 68 weeks vs −3.0% placebo. 99.4% achieved ≥5% reduction vs 31.5% placebo. Over 50% reached BMI below obesity threshold (vs 10.2% placebo). Cagrilintide monotherapy arm: −11.8% BW. Published N Engl J Med 2025;393:635–647.
Cagrilintide: A Long-Acting Amylin Analog for the Treatment of Obesity
Comprehensive structural and pharmacological characterization of cagrilintide. Details the DACRA (dual amylin-calcitonin receptor agonist) mechanism, C18 fatty diacid albumin binding strategy (~168 hr half-life vs ~2 min native amylin), Aib8 DPP-IV resistance, and Cys2–Cys7 disulfide preservation. Reviews Phase 1 and Phase 2 data. Establishes the mechanistic basis for amylin/GLP-1 combination synergy. Primary structural reference for cagrilintide in published literature. Cardiol Rev. 2024 Jan-Feb;32(1):83-90.
Cagrilintide Lowers Bodyweight Through Brain Amylin Receptors 1 and 3
RAMP1/3 knockout (KO) mouse study confirming AMY1R and AMY3R receptor dependence of cagrilintide's weight loss effects. Male WT and KO mice on high-fat diet treated with vehicle, salmon calcitonin, or cagrilintide (3 nmol/kg, subcutaneous). Cagrilintide-induced weight loss and lean mass preservation were significantly attenuated in KO mice, confirming AMY1R/3R as primary effectors. Energy expenditure was maintained — a distinction from GLP-1 monotherapy. PMC 12270663. Received Feb 2025; Accepted Jun 2025.
CagriSema in Adults with Type 2 Diabetes and Overweight or Obesity — REDEFINE 2
68-week Phase 3 RCT in 1,206 adults with T2D and obesity or overweight. CagriSema achieved mean BW change of −13.7% vs −3.4% placebo. HbA1c reductions: −1.8 pp (CagriSema) vs +0.1 pp (placebo). Extends REDEFINE 1 findings to the T2D population, a mechanistically important finding given amylin's role in glucose regulation independent of insulin secretion. Data basis for the NDA submitted December 2025.
Coadministered Cagrilintide and Semaglutide — Phase 2 Dose-Finding Results
Phase 2 dose-finding trial of CagriSema in adults with obesity. CagriSema 2.4+2.4 mg achieved −15.6% mean BW change at 32 weeks vs −5.1% semaglutide alone and −8.1% cagrilintide alone. Established the synergy hypothesis: amylin pathway (cagrilintide) + GLP-1 pathway (semaglutide) produce additive weight change effects beyond either monotherapy. Foundation for REDEFINE Phase 3 program design.
REDEFINE 3: Cardiovascular Outcomes Trial of CagriSema (NCT05669027)
Event-driven cardiovascular outcomes Phase 3 trial of once-weekly CagriSema vs placebo in adults with established CVD and obesity or overweight, without T2D. Primary endpoint: MACE (CV death, nonfatal MI, nonfatal stroke). Will determine whether amylin+GLP-1 pathway combination provides cardiovascular benefit comparable to or exceeding GLP-1 monotherapy SELECT data (semaglutide, HR 0.80). Estimated completion 2028.
The Next Frontier in Metabolic Health: Cagrilintide-Semaglutide and the Evolving Landscape of Therapies
Comprehensive review of the CagriSema mechanistic rationale, clinical development, and positioning against GLP-1, dual incretin, and triple receptor agonist compounds. Discusses amylin receptor complex (CTR+RAMP1/3) biology, the thermogenic and lean-mass-preserving properties of the amylin pathway distinct from the GLP-1 axis, and the pipeline of competing amylin analogs (petrelintide, eloralintide, AZD6234). The Innovation Medicine 3:100150 (2025). DOI: 10.59717/j.xinn-med.2025.100150.
Cagrilintide Monotherapy Phase 3 Sub-Analysis — EASD 2025 Presentation Review
Detailed analysis of the EASD 2025 cagrilintide monotherapy sub-analysis presentation. Reviews the −11.8% (12.5 kg) mean BW change at 68 weeks vs −2.3% placebo, the 1.0% nausea discontinuation rate (lower than comparable GLP-1 agents), and the statistical methodology differentiating the treatment policy vs treatment effect estimands. Contextualizes the RENEW program launch and the scientific rationale for pursuing standalone cagrilintide approval alongside CagriSema.
Indexed from PubMed, ClinicalTrials.gov, and peer-reviewed journals. Independent published research — not Trident Labs claims. AMY-1CA (Cagrilintide) is an investigational compound not approved by the FDA. For Research Use Only — Not for Human Consumption. Not a drug, food, dietary supplement, cosmetic, or medical device. For lawful laboratory research use only by qualified researchers.
Cited Sources
References
All scientific claims sourced from peer-reviewed literature or official trial registrations.
Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity — REDEFINE 1
Cagrilintide: A Long-Acting Amylin Analog for the Treatment of Obesity
Cagrilintide Lowers Bodyweight Through Brain Amylin Receptors 1 and 3
Coadministered Cagrilintide and Semaglutide — Phase 2 Dose-Finding
Efficacy and Safety of Cagrilintide 2.4 mg in Adults with Overweight/Obesity — REDEFINE 1 Sub-Analysis
The Next Frontier in Metabolic Health: Cagrilintide-Semaglutide and the Evolving Landscape
Novo Nordisk Files for FDA Approval of CagriSema
REDEFINE 3 — Cardiovascular Outcomes Phase 3 Trial of CagriSema
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