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Metabolic · In Clinical Trials

CagriSema

No lawful US pathway

Written by Peptide Association Editorial TeamLast reviewed Editorial policy

01 · Overview

CagriSema is a once-weekly combination of cagrilintide, a long-acting amylin analog, and semaglutide, a GLP-1 receptor agonist, both delivered as peptides by subcutaneous injection. Cagrilintide acts on amylin receptors to promote satiety, while semaglutide enhances glucose-dependent insulin secretion and reduces appetite.

The combination is intended to achieve greater weight loss than either agent alone.

02 · Research summary & key findings

In a 32-week phase 2 trial in type 2 diabetes, CagriSema produced greater weight loss than semaglutide or cagrilintide alone (15.6 vs. 5.1 and 8.1 percent), while its HbA1c reduction was not significantly greater than semaglutide alone (PMID 37364590). In the 68-week phase 3 REDEFINE 1 trial in adults with overweight or obesity without diabetes, mean weight change was -20.4 percent versus -3.0 percent with placebo (PMID 40544433). Gastrointestinal adverse events affected about 80 percent of CagriSema recipients and were mainly transient and mild to moderate (PMID 40544433).

03 · Regulatory status

CagriSema is currently undergoing clinical trials. It is not yet FDA-approved and is available only through clinical research settings or investigational protocols.

No lawful pathway today

CagriSema is not FDA-approved and does not currently have a lawful prescription or compounding pathway in the United States, so we do not sell it and will not book a consultation for it. That can change: in 2026 FDA began reviewing several peptides for compounding. If you are working on the goal it is studied for, a licensed clinician can tell you what is lawfully available, which may be something else.

See the 13 FDA-approved compounds in Metabolic

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Looking for a lawful, clinician-prescribed option for metabolic health and weight?

CagriSema is still in clinical trials, is not FDA-approved, and has no lawful US compounding pathway, so we do not offer it and no clinician we work with will prescribe it. Products sold online as “research chemicals” are not made or tested to the standards required of medicines. If you are working on metabolic health and weight, a licensed clinician can tell you at a free consultation whether an FDA-approved or lawfully compounded treatment fits you, or whether nothing does.

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04 · Administration routes

  • Subcutaneous injection

References

  1. [1]Efficacy and safety of co-administered once-weekly cagrilintide 2·4 mg with once-weekly semaglutide 2·4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial Lancet, 2023. PMID 37364590
  2. [2]Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity N Engl J Med, 2025. PMID 40544433

Primary literature

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Disclaimer: This information is provided for educational and research purposes only. It is not intended as medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting any peptide therapy. The Peptide Association does not endorse or recommend any specific treatment protocol. See our editorial policy for how this content is produced and reviewed. Clinicians: join the network.