Peptide Graded

CagriSema

Does CagriSema work?

Yes, in large controlled trials of 3,417 and 1,206 people.

AStrong human evidenceIn clinical trialsas of 2026-10-26

Two large phase 3 randomized placebo-controlled trials support the weight-loss use: REDEFINE 1 randomized 3,417 adults with overweight or obesity and REDEFINE 2 randomized 1,206 adults with type 2 diabetes, both over 68 weeks. A thorough QT study (105 participants) and a phase 2 trial of cagrilintide alone round out the human data. What is missing is regulatory approval and long-term outcome data beyond 68 weeks. 45102

REDEFINE 1 enrolled 3,417 adults without diabetes. They had obesity, or overweight with a related condition. Researchers randomized them to CagriSema, either component alone, or placebo. All groups also got lifestyle counselling. At week 68, the estimated mean weight change was -20.4% with CagriSema and -3.0% with placebo. People on CagriSema were more likely to lose 5%, 20%, 25% and 30%. 4

REDEFINE 2 enrolled 1,206 adults with type 2 diabetes and a body-mass index of 27 or more. At 68 weeks, weight fell 13.7% with CagriSema and 3.4% with placebo. Glycated hemoglobin reached 6.5% or lower in 73.5% of the CagriSema group, against 15.9% on placebo. 5

Evidence checklist

  • Randomised controlled trial REDEFINE 1 and 2, placebo-controlled
  • Human study over 100 people REDEFINE 1, 3,417 adults
  • More than one research group Trials all sponsored by Novo Nordisk
  • Clinical outcomes, not surrogate markers Weight and HbA1c, not outcomes
  • Human safety data beyond case reports Safety data from two large phase 3 trials

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Citations

  1. StatPearls: Glucagon-like peptide-1 receptor agonists ncbi.nlm.nih.gov
  2. Lau 2021, Lancet: once-weekly cagrilintide for weight management, phase 2 doi.org
  3. Novo Nordisk Q4 2025 report to the SEC: CagriSema submission sec.gov
  4. Garvey 2025, NEJM: coadministered cagrilintide and semaglutide (REDEFINE 1) pubmed.ncbi.nlm.nih.gov
  5. Davies 2025, NEJM: cagrilintide-semaglutide in type 2 diabetes (REDEFINE 2) pubmed.ncbi.nlm.nih.gov
  6. FDA: concerns with unapproved GLP-1 drugs used for weight loss fda.gov
  7. Jastreboff 2022, NEJM: tirzepatide once weekly for obesity (SURMOUNT-1) pubmed.ncbi.nlm.nih.gov
  8. Novo Nordisk 6-K, February 2026: REDEFINE 4 headline results sec.gov
  9. Novo Nordisk 6-K, December 2024: REDEFINE 1 headline results sec.gov
  10. 2024, Diabetes Obes Metab: cagrilintide thorough QT study pubmed.ncbi.nlm.nih.gov
  11. 2024, Diabetes Obes Metab: lean body mass changes with GLP-1-based therapies pubmed.ncbi.nlm.nih.gov
  12. DailyMed: Wegovy (semaglutide) prescribing information dailymed.nlm.nih.gov

Reference information only, not medical advice. Drawn from the CagriSema article, fact-checked against the cited sources. No dosing anywhere on this site.