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Monograph
RESEARCH GREYG-003
Metabolic

CagriSema (cagrilintide + semaglutide)

Fixed-dose combination of cagrilintide (long-acting amylin analog, 2.4 mg) + semaglutide (GLP-1 agonist, 2.4 mg). Dual-mechanism: GLP-1 drives satiety + insulin, amylin adds independent satiety + gastric emptying modulation. 20.4% body weight reduction at 68 weeks (REDEFINE 1).

EmergingMetabolic
Typical dosecagrilintide 2.4 mg + semaglutide 2.4 mg, once weekly (Phase 3 dose — not yet approved)
Frequencyonce weekly subcutaneous — NDA under FDA review as of Dec 2025; no approved dosing yet
Half-life168h
Citations indexed6
DeliveryInjectable
Half-life~7d
EvidenceEmerging
Citations6
Similar compounds
Synergy checkCompareReconstitution calc
Research grey

This compound sits in research-grey territory. The caveats below carry more weight than for FDA-approved entries — read them.

Mechanism

Novo Nordisk's amylin + GLP-1 combination rationale: amylin (secreted by pancreatic beta cells alongside insulin) acts via calcitonin receptor in the hypothalamus to independently reduce food intake and slow gastric emptying — a mechanism that doesn't overlap with GLP-1 satiety signaling. The combination produces additive satiety from two mechanistically distinct pathways. REDEFINE 1 (Phase 3, 68 weeks, 3,417 adults without T2D): 20.4% mean weight reduction vs 3.0% placebo. REDEFINE 4 (head-to-head vs tirzepatide 15 mg, 84 weeks): CagriSema 23.0% vs tirzepatide 25.5% — CagriSema non-inferior but NOT superior. NDA submitted to FDA December 18, 2025. FDA review expected 2026. Cleanest path to FDA approval in this cluster.

Specifics
Weight / fat lossAppetite controlInsulin sensitivity
Caveats

HONEST FRAMING — DO NOT pitch CagriSema as better than tirzepatide: REDEFINE 4 head-to-head (84 weeks) shows CagriSema 23.0% vs tirzepatide 15 mg 25.5% — non-inferior, NOT superior. Wegovy (semaglutide 2.4 mg alone) is the relevant comparator for the semaglutide component — CagriSema adds ~4-6% weight loss over Wegovy via the cagrilintide component. GI side effects class-wide. Novo Nordisk funded all REDEFINE trials — treat claims as B-grade.

Evidence levelEmerging
Regulatory statusNDA submitted to FDA December 18, 2025. FDA review expected 2026. Not yet approved. Cagrilintide as a standalone compound is on the 503A-restricted list — no compounding path until FDA approval.
DNA / pharmacogenomicsLow — Semaglutide component is GLP-1R-mediated — same receptor polymorphism considerations as semaglutide apply. Cagrilintide calcitonin-receptor component has no documented pharmacogenomic literature.
References

External links to PubMed searches, ClinicalTrials.gov, and FDA materials. We do not host papers — we point at canonical sources.

  • PubMedEN
    RCTIndustry-fundedVerified 3d ago
    DOI 10.1056/NEJMoa2502081 — REDEFINE 1 CagriSema Phase 3 (NEJM)
  • PubMedEN
    RCTIndustry-fundedVerified 3d ago
    DOI 10.1056/NEJMoa2502082 — REDEFINE 2 CagriSema + T2D (NEJM)
RESEARCH GREYG-003

NDA submitted to FDA December 18, 2025. FDA review expected 2026. Not yet approved. Cagrilintide as a standalone compound is on the 503A-restricted list — no compounding path until FDA approval.

Can I get it? →
Reconstitution calculatorCagriSema

Pre-filled with this compound's published dose range: cagrilintide 2.4 mg + semaglutide 2.4 mg, once weekly (Phase 3 dose — not yet approved) · once weekly subcutaneous — NDA under FDA review as of Dec 2025; no approved dosing yet

Concentration2.50 mg/mL
Draw volume0.960 mL
Insulin syringe96.0 u
Doses per vial2
U-100 syringe — fill to indicatorU-100 · 1 mL
0u25u50u75u100u

Calculator is a discussion tool. Verify reconstitution + dosing with a qualified provider. Stack is not a prescription source. Use sterile technique and inspect every vial.

Field reports

Distilled themes from named communities — Reddit threads, forums, creator commentary. Not direct quotes; not clinical evidence. Useful for calibrating expectations against what real self-experimenters report.

r/Ozempic + r/WeightLossAdvice CagriSema discussion

Cohort is Wegovy plateau users primarily. The amylin add-on framing resonates — 'same semaglutide but with something extra.' Head-to-head vs tirzepatide data lands honestly: most users accept non-inferior is still good. FDA approval watch is active — the NDA filing date is known and community is tracking review timeline.

CagriSemacagrilintide 2.4 mg + semaglutide 2.4 mg, once weekly (Phase 3 dose — not yet approved) · once weekly subcutaneous — NDA under FDA review as of Dec 2025; no approved dosing yet
Discussion guide, not prescription

stack is an exploration engine. Output is a discussion guide for a conversation with a licensed provider — never a prescription, dose recommendation, or sourcing instruction. Peptides discussed include compounds with limited human evidence and varying legal status by jurisdiction. Verify everything with a qualified clinician before any decision.

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