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Home / Encyclopedia / GLP-1 & Weight / CagriSema
MONOGRAPH No. 103
EVIDENCE BASEModerate
TYPE
Amylin + GLP-1 co-formulation
MW
Two-peptide combination
CAS
Not assigned
EU STATUS
Filed · Not yet approved
WADA
GLP-1 component not prohibited
MIN PURITY
≥98% HPLC
⚖ GLP-1 & Weight

CagriSema — EU research guide.

CagriSema is Novo Nordisk's once-weekly fixed-dose combination of cagrilintide (an amylin analogue) and semaglutide (a GLP-1 receptor agonist), developed for obesity and type 2 diabetes.

Last reviewed:

What is CagriSema?

CagriSema is a once-weekly subcutaneous co-formulation of two peptides: cagrilintide, a long-acting amylin analogue, and semaglutide, a GLP-1 receptor agonist. The rationale is mechanistic complementarity — amylin and GLP-1 act on partly different appetite and satiety pathways, so combining them is intended to produce greater weight loss than either alone. It is a fixed-dose combination (2.4 mg / 2.4 mg in the pivotal trials), not a single new molecule.

What does the research show?

In the Phase 3 REDEFINE 1 trial (adults with obesity, without diabetes), CagriSema produced a mean weight reduction of ~22.7% at 68 weeks under the "if all adhere" estimand, versus ~16.1% for semaglutide alone and ~11.8% for cagrilintide alone — confirming the combination outperforms its components. REDEFINE 2 (obesity with type 2 diabetes) showed ~15.7% weight loss. The results fell short of Novo Nordisk's internal 25% ambition but remain among the highest reported for an approved-mechanism obesity therapy. Novo Nordisk submitted CagriSema to the US FDA in December 2025; as of mid-2026 it is not yet approved.

EU legal status

Not yet approved in the EU. CagriSema is a proprietary fixed-dose combination owned by Novo Nordisk and under regulatory review. It is not a generic research peptide; gray-market material claiming to replicate the CagriSema combination cannot be assumed to match the clinical formulation or dosing.

⚠ Proprietary combination under regulatory review. Not yet EMA/FDA-approved. No human use outside authorised clinical trials. A self-mixed "CagriSema" is not the validated clinical product.
✓ PeptideCompare tracks the individual components — cagrilintide and semaglutide — from EU research vendors with COA documentation.
EVIDENCE SUMMARY
MODERATE
Weight reduction, adults without diabetes (REDEFINE 1) — In a 68-week, placebo-controlled phase 3 trial of 3,417 adults with overweight or obesity, mean weight loss was 20.4% with the combination versus 3.0% with placebo (all randomised participants); the developer reports 22.7% versus 2.3% if all participants adhered to treatment. Nausea (55% vs 12.6%) and other gastrointestinal events were the most common adverse events, and 6% vs 3.7% stopped for adverse events.
MODERATE
Weight and glycaemic control, type 2 diabetes (REDEFINE 2) — In a 68-week phase 3 trial of 1,206 adults with type 2 diabetes and overweight or obesity, mean weight loss was 13.7% versus 3.4% with placebo (15.7% versus 3.1% if all adhered), and 74% reached an HbA1c of 6.5% or lower versus 15.9% with placebo.
MODERATE
Head-to-head with tirzepatide (REDEFINE 4) — In an open-label, 84-week trial of 809 adults, CagriSema missed its primary goal of non-inferiority to tirzepatide on weight loss: 23.0% versus 25.5% if all adhered and 20.2% versus 23.6% regardless of adherence, as reported in February 2026. Only a news report of this trial was checked, not the full paper.

Molecular information

Molecular weight
Two-peptide combination
CAS number
Not assigned

Pharmacokinetics

No established human pharmacokinetic data. Published human PK parameters for this compound are not available; reported data are limited to animal models or absent. No curve is shown, to avoid implying data that does not exist.

Potency retained over time

Each line is one storage condition: it starts at 100% and falls as potency is lost. Above the dashed 80% line the material is considered reliable — hover for exact values.

Freezer −20 °C
36+ mo
Stable · >95% potency
Fridge 4 °C
4-6 mo
In use · after recon
Room 20 °C
2-3 wks
Limited · moderate loss
Warm 37 °C+
<1 day
Critical · rapid degradation

⚠ Modelled per compound from molecular structure — chain length, cyclisation, oxidation- and deamidation-prone residues and light sensitivity. Indicative only, not lab-measured per batch.

Cagrilintide & semaglutide across EU suppliers

COA-verified EU vendors · Updated monthly

References

  1. Peer-reviewed report of REDEFINE 1 (3,417 adults, 68 weeks, placebo-controlled): clearly greater weight loss than placebo, with mostly mild-to-moderate gastrointestinal adverse events. It is a sponsor-run trial and says nothing about what happens beyond 68 weeks. Garvey WT, Blüher M, Osorto Contreras CK, Davies MJ, Winning Lehmann E, Pietiläinen KH, Rubino D, Sbraccia P, Wadden T, Zeuthen N, Wilding JPH; REDEFINE 1 Study Group. Coadministered cagrilintide and semaglutide in adults with overweight or obesity. N Engl J Med. 2025;393(7):635-647. DOIPubMed 40544433
  2. Peer-reviewed report of REDEFINE 2 in adults with type 2 diabetes (1,206 participants, 68 weeks). Weight loss was smaller than in people without diabetes, and safety was described as similar to REDEFINE 1. Davies MJ, Bajaj HS, Broholm C, et al.; REDEFINE 2 Study Group. Cagrilintide-semaglutide in adults with overweight or obesity and type 2 diabetes. N Engl J Med. 2025 (published online 22 June 2025). DOIPubMed 40544432
  3. Developer press release announcing the US FDA new drug application. It confirms the filing, not an approval; it mentions no EU submission, and the sources checked showed no approval as of September 2026. Novo Nordisk A/S. Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP-1 and amylin analogues for weight management. Press release, 18 December 2025. Source
  4. Developer press release summarising the REDEFINE 1 and 2 results under both analysis methods, plus discontinuation rates and adverse events. A company source, best read next to the NEJM papers. The licensed product is not the same as vendor-sold research material. Novo Nordisk A/S. CagriSema demonstrated 22.7% mean weight reduction in adults with overweight or obesity in REDEFINE 1, published in NEJM. Press release, 2025. Source
  5. Trade-press report on the head-to-head trial against tirzepatide, which did not show non-inferiority. It is not a peer-reviewed publication and the full trial paper was not checked. Clinical Trials Arena. Novo Nordisk's CagriSema bested by Lilly's Zepbound in head-to-head trial. News report, February 2026. Source

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