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  • How-to guides

    CagriSema Results: REDEFINE Phase 3 Data, Cagrilintide + Semaglutide Mechanism and How It Compares

    Short answer: CagriSema is two molecules in one weekly injection — cagrilintide 2.4 mg, a long-acting amylin analogue , plus semaglutide 2.4 mg, the GLP-1 agonist behind Wegovy. Novo Nordisk pairs them because amylin and GLP-1 suppress appetite through different circuits, so the effects stack. Phase 3 REDEFINE 1 reported 20.4% mean weight loss at 68 weeks versus 3.0% with placebo (treatment-policy estimand, N Engl J Med 2025); Novo Nordisk’s topline efficacy-estimand figure of ~22.7% was impressive, but below Novo’s own ~25% target. Novo Nordisk has announced an FDA submission; the sources reviewed for this page report no marketing authorisation as of mid-2026, and we have not verified a later decision. Both components are catalogued by New-U as research references. Part of our next obesity-research wave overview.

    Plain-English summary. CagriSema (the fixed-dose product) is unapproved and investigational. The components , cagrilintide and semaglutide, are well-characterised research-reference peptides New-U catalogues for laboratory use. This page is general information, not legal or medical advice; do not use unapproved compounds on people.

    What CagriSema actually is

    CagriSema is not a new molecule — it is a fixed-dose combination of two existing ones in a single weekly subcutaneous shot:

  • Cagrilintide 2.4 mg — a long-acting analogue of amylin , the satiety hormone co-secreted with insulin from pancreatic beta cells.
  • Semaglutide 2.4 mg — the 31-amino-acid GLP-1 receptor agonist already approved as Wegovy and Ozempic. See our semaglutide research guide.
  • The logic is mechanistic complementarity, covered next.

    Why amylin + GLP-1 is additive

    GLP-1 and amylin both reduce appetite, but they do it through distinct circuits , which is exactly why combining them works:

  • GLP-1 (semaglutide) — slows gastric emptying, acts on hypothalamic and hindbrain appetite centres, and improves glucose-dependent insulin secretion.
  • Amylin (cagrilintide) — signals satiety through amylin receptors and, importantly, appears to restore leptin sensitivity , so the “I’m full” signal lands harder. This is a different lever from GLP-1.
  • Because the two pathways are largely non-overlapping, REDEFINE 1 showed the combination beating either component on its own. For the amylin mechanism in isolation, see our guide to the pure amylin analogue petrelintide.

    The REDEFINE Phase 3 evidence

    REDEFINE 1 (Garvey et al., N Engl J Med 2025) was a 68-week trial in 3,417 adults without diabetes with a BMI of 30 or more, or 27 or more with at least one obesity-related complication (mean baseline weight 106.9 kg), randomised to CagriSema, semaglutide alone, cagrilintide alone or placebo. Headline results:

    Metric CagriSema Placebo Mean weight loss (treatment-policy estimand; primary, published) −20.4% −3.0% Mean weight loss (efficacy estimand; Novo Nordisk topline) ~−22.7% ~−2.3% Participants reaching ≥25% weight loss 40.4% 0.9% Participants reaching ≥5% weight loss 91.9% 31.5%

    For context, in the same comparison cagrilintide alone and semaglutide alone produced far fewer ≥25% responders (~6% and ~16% respectively), illustrating the additive effect. The efficacy-estimand and responder rows are from Novo Nordisk’s topline release; the published paper’s primary analysis is the treatment-policy estimand, an estimated difference of −17.3 percentage points versus placebo (PMID 40544433). Gastrointestinal adverse events were reported by 79.6% of the CagriSema group and 39.9% of the placebo group, mainly transient and mild to moderate. A secondary analysis of REDEFINE 1 (Verma et al., Hypertension 2026) reported systolic blood pressure changes of −10.9 versus −2.8 mm Hg with CagriSema versus placebo.

    Type 2 diabetes and head-to-head data. The diabetes companion weight trial REDEFINE 2 (Davies et al., N Engl J Med 2025) randomised 1,206 adults with obesity or overweight and type 2 diabetes: mean weight change at 68 weeks was −13.7% with CagriSema versus −3.4% with placebo (treatment-policy estimand), and an HbA1c of 6.5% or less was reached by 73.5% versus 15.9%. The headline HbA1c result comes from a different programme, REIMAGINE :

  • REIMAGINE 2 (Buse et al., Lancet Diabetes Endocrinol 2026): in type 2 diabetes on metformin with or without an SGLT2 inhibitor, HbA1c fell by 1.91 percentage points with CagriSema (2.4 mg each) versus 1.75 with semaglutide 2.4 mg at 68 weeks (efficacy estimand; superiority shown).
  • REIMAGINE 1 (Aroda et al., Lancet Diabetes Endocrinol 2026): in early type 2 diabetes managed with diet and exercise, HbA1c fell by 1.8 percentage points with CagriSema (2.4 mg each) versus 0.1 with placebo at 40 weeks (efficacy estimand).
  • REIMAGINE 3 (Rosenstock et al., Lancet 2026): added to basal insulin, HbA1c fell by 2.33 percentage points with CagriSema (2.4 mg each) versus 0.66 with placebo at 40 weeks (efficacy estimand), with no severe hypoglycaemia reported.
  • REDEFINE 5 (Yamauchi et al., Lancet Diabetes Endocrinol 2026): in 331 adults in Japan and Taiwan with overweight or obesity, with or without type 2 diabetes, mean weight change at 68 weeks was −18.4% with CagriSema versus −11.9% with semaglutide alone (trial-product estimand), a head-to-head comparison against the GLP-1 component.
  • All of these describe Novo Nordisk’s investigational product in clinical trials, not any research-grade material.

    The 25% story. Novo Nordisk had guided the market toward roughly 25% mean weight loss. Landing at ~22.7% was a clinically strong result that nonetheless missed expectations — a reminder that in this field the bar is now set by the previous best, not by placebo. (The ~22.7% figure is the efficacy-estimand topline; the published primary figure is 20.4%.) Novo Nordisk subsequently announced an FDA submission.

    How CagriSema compares

    Compound Mechanism Best documented mean weight loss Status CagriSema Amylin + GLP-1 20.4% / 68 wks (REDEFINE 1, treatment-policy; ~22.7% efficacy-estimand topline) FDA submission announced; not approved as of mid-2026 Semaglutide GLP-1 ~14.9% / 68 wks (STEP-1) Approved Tirzepatide GLP-1 + GIP ~20.9% / 72 wks (SURMOUNT-1) Approved Retatrutide GLP-1 + GIP + glucagon ~24.2% / 48 wks (Phase 2) Phase 3, no approval

    CagriSema components as research compounds

    Unusually for this pipeline, both CagriSema components are established, verifiable research-reference peptides that New-U catalogues:

  • Cagrilintide — the long-acting amylin analogue, the same molecule studied in the REDEFINE programme.
  • Semaglutide — the GLP-1 single agonist.
  • Each ships as a sealed, lyophilised reference peptide verified to >99% HPLC purity by Janoshik and Freedom Diagnostics, with the per-batch Certificate of Analysis published online. The fixed-dose CagriSema co-formulation itself is a proprietary Novo Nordisk product and is not a research reagent.

    How to verify the components’ purity

  • HPLC purity >99% by reversed-phase chromatography, on each component.
  • Mass-spec identity match to the calculated mass of the cagrilintide and semaglutide sequences.
  • Named third-party lab on the CoA, published for the batch on sale.
  • Full walkthrough: How to Read a Certificate of Analysis.

    Frequently Asked Questions

    What is CagriSema? Novo Nordisk’s investigational once-weekly combination of cagrilintide 2.4 mg (amylin analogue) and semaglutide 2.4 mg (GLP-1 agonist).

    Is CagriSema approved? No. Novo Nordisk has announced an FDA submission; the sources reviewed for this page (mid-2026) report no marketing authorisation, and we have not verified a later regulatory decision.

    How much weight loss? In REDEFINE 1 (NEJM 2025), 20.4% mean weight loss at 68 weeks versus 3.0% with placebo on the treatment-policy estimand. Novo Nordisk’s topline efficacy-estimand figure was ~22.7% — strong, but below Novo’s ~25% target.

    Why combine amylin and GLP-1? They suppress appetite through different circuits, so the effect is additive — the combination beat either component alone.

    Are the components available for research? Yes — New-U catalogues cagrilintide and semaglutide as reference peptides.

    Related Reading

  • Beyond GLP-1: The Next Obesity Research Wave
  • Petrelintide: the long-acting amylin analogue
  • Amycretin: amylin + GLP-1 in one molecule
  • Semaglutide research guide
  • How to Read a Certificate of Analysis
  • Retatrutide vs CagriSema: one triple agonist vs a two-molecule combination
  • Retatrutide vs cagrilintide: triple agonist vs amylin analogue
  • cagrilintide product page
  • Primary sources & further reading

  • Novo Nordisk — CagriSema REDEFINE 1 results
  • Novo Nordisk — REDEFINE 2 (type-2 diabetes) topline result
  • Novo Nordisk — CagriSema FDA filing announcement
  • Garvey WT et al. — Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (REDEFINE 1), N Engl J Med 2025
  • Davies MJ et al. — Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes (REDEFINE 2), N Engl J Med 2025
  • Buse JB et al. — CagriSema versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2), Lancet Diabetes Endocrinol 2026
  • Aroda VR et al. — CagriSema in type 2 diabetes inadequately controlled on diet and exercise (REIMAGINE 1), Lancet Diabetes Endocrinol 2026
  • Rosenstock J et al. — CagriSema as an add-on to basal insulin in type 2 diabetes (REIMAGINE 3), Lancet 2026
  • Yamauchi T et al. — Cagrilintide and semaglutide versus semaglutide alone in Japan and Taiwan (REDEFINE 5), Lancet Diabetes Endocrinol 2026
  • Verma S et al. — CagriSema Reduces Blood Pressure in Adults With Overweight or Obesity: REDEFINE 1, Hypertension 2026
  • U.S. National Library of Medicine — PubMed: cagrilintide / semaglutide
  • ClinicalTrials.gov — REDEFINE programme
  • U.S. FDA — FDA (CagriSema not approved as of publication)
  • External links are provided for research reference only; New-U is not affiliated with the cited organisations and links carry no endorsement either way.

    From the Lab - Peptides on LinkedIn, TikTok & X

    Lab-Verified Cagrilintide & Semaglutide

    New-U Research Compounds catalogues both CagriSema components — cagrilintide and semaglutide — as sealed 10-vial packs of lyophilised reference peptide, independently verified by Janoshik and Freedom Diagnostics for >99% HPLC purity, with the per-batch Certificate of Analysis published online. Research use only - all claims made on this site are for testing and research use only.

    Research-grade · >99% HPLC purity · COA per lot

    Buy Cagrilintide from New-U Research Compounds

    Lab-verified by Janoshik Analytical (RP-HPLC + ESI-MS), sealed vials, discreet tracked worldwide shipping. Research use only - all claims made on this site are for testing and research use only.

    Part of the Metabolic & GLP-1 research research area — explore related compounds, guides and sources.

    PRECISION. PURITY. PERFORMANCE.

    Research peptides. Third-party Certificates of Analysis (Janoshik Analytical & Freedom Diagnostics) are published on the website. Supplied strictly for laboratory research use.

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