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CagriSema: Amylin + GLP-1 Combination

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CagriSema combines cagrilintide (amylin) and semaglutide (GLP-1) in a single weekly injection. Phase 3 trials show 22.7% weight loss. NDA filed December 2025, with FDA approval expected late 2026.

01

REDEFINE 1 (68 wks)

REDEFINE 1 (68 wks)
TreatmentWeight lossResponders (≥10%)Responders (≥20%)
CagriSema-22.7%~80%~55%
Semaglutide 2.4 mg alone-16.1%~65%~35%
Cagrilintide 2.4 mg alone-11.8%~48%~20%
Placebo-2.3%~8%~3%
02

REDEFINE 2 (68 wks)

REDEFINE 2 (68 wks)
EndpointCagriSemaPlacebo
Weight loss-15.7%-3.1%
HbA1c reductionSignificantModest
Proportion reaching ≥10% weight loss~60%~10%
03

REDEFINE 3 and REDEFINE 4

  • REDEFINE 3: ~7,000 participants, cardiovascular (CV) outcomes, results expected 2027-2028.
  • REDEFINE 4: head-to-head vs tirzepatide 15 mg, 800 participants, 72-week, results expected 2026-2027.
  • A REIMAGINE trial is referenced for a type 2 diabetes (T2D) submission (mentioned once, no further detail provided).
04

CagriSema vs. Other Weight Loss Medications

FeatureCagriSemaSema 2.4 (Wegovy)Tirz 15 (Zepbound)Reta 12
MechanismAmylin + GLP-1GLP-1 onlyGIP + GLP-1GIP + GLP-1 + Glucagon
RouteWeekly injectionWeekly injectionWeekly injectionWeekly injection
Phase 3 Weight Loss22.7%~15-17%~22-26%~24-29%
DeveloperNovo NordiskNovo NordiskEli LillyEli Lilly
FDA StatusNDA filed Dec 2025Approved 2021Approved 2023Phase 3 ongoing
Expected ApprovalLate 2026/Early 2027——~2027
FAQ

Frequently asked questions

How is CagriSema different from Wegovy?

Both contain semaglutide 2.4 mg, but CagriSema adds cagrilintide — a long-acting amylin analogue that suppresses appetite through a separate brain pathway. This combination produced 22.7% weight loss versus approximately 15-17% with semaglutide alone.

When will CagriSema be available?

Novo Nordisk filed the NDA with the FDA in December 2025. Approval is expected in late 2026 or early 2027, with a U.S. market launch anticipated in 2027.

Is CagriSema better than Zepbound (tirzepatide)?

Phase 3 data suggests comparable weight loss (~22.7% for CagriSema vs. ~22-26% for tirzepatide), but head-to-head results from REDEFINE 4 are expected in 2026-2027 and will provide a definitive comparison.

What are the main side effects?

Gastrointestinal symptoms are most common — nausea, diarrhea, vomiting, and constipation. These are consistent with the GLP-1 agonist class and typically improve after the initial titration period.

Will insurance cover CagriSema?

Coverage will depend on individual insurance plans and payer decisions. Obesity treatment coverage has expanded significantly since semaglutide's approval, and the trend is expected to continue as clinical evidence for weight loss medications grows.

References
  1. 01Novo Nordisk press release, Dec 18, 2025
  2. 02REDEFINE 1 (ObesityWeek 2024)
  3. 03REDEFINE 2 (ADA Scientific Sessions 2025)
  4. 04Frias JP, et al. "Cagrilintide plus semaglutide for obesity." NEJM. 2024
  5. 05Novo Nordisk REDEFINE Clinical Trial Program Overview (ClinicalTrials.gov).

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