CagriSema
Cagrilintide/semaglutide fixed-dose combination
Clinical trials are ongoing or recently completed. Final approval has not been granted.
An investigational once-weekly combination injection that pairs two appetite-controlling medications to produce powerful weight loss. In a major clinical trial, people lost an average of 20% of their body weight over about 16 months, compared to just 3% with placebo (an inactive comparison treatment). This medication is not yet approved.
This entry is a cited research summary, not an established treatment reference. Dosing language is included as source context, not as medical instruction.
CagriSema has substantial clinical evidence but is not FDA-approved.
Clinical trials are ongoing or recently completed. Final approval has not been granted.
Safety Summary
In REDEFINE 1, gastrointestinal adverse events affected 79.6% of the CagriSema group vs 39.9% of placebo, including nausea, vomiting, diarrhea, constipation, and abdominal pain. Most were transient and mild-to-moderate in severity PMID 40544433. In REDEFINE 2, GI AEs affected 72.5% of the CagriSema group vs 34.4% of placebo PMID 40544432. In the Phase 2 trial, AEs were reported by 68% of CagriSema participants, 71% semaglutide, and 80% cagrilintide; no level 2 or 3 hypoglycemia or fatal AEs were reported PMID 37364590. A meta-analysis of 4 RCTs (N=4419) found GI AEs were more frequent with CagriSema vs controls (RR 1.32) PMID 41759565. Vomiting was significantly higher with CagriSema vs semaglutide monotherapy in a separate meta-analysis of 3 RCTs (N=430) PMID 39676787. The cagrilintide component showed no clinically relevant QTcF prolongation at supratherapeutic doses (4.5 mg) in a dedicated cardiac safety study in healthy participants PMID 39279639.
Clinical check-in
If real-world use or exposure is being considered, review potential interactions, contraindications, and monitoring needs with a licensed clinician rather than relying on summary copy alone.
Cited sources
Every claim on this page links to one of the 12 sources below. Identifiers are PubMed (PMID), ClinicalTrials.gov (NCT), or DOI; click through to the source of record before acting on a claim.
- 1PMID 40544433PubMed
- 2PMID 40544432PubMed
- 3PMID 37364590PubMed
- 4PMID 41328546PubMed
- 5PMID 40629149PubMed
- 6PMID 41759565PubMed
- 7PMID 39676787PubMed
- 8PMID 38286487PubMed
- 9PMID 39279639PubMed
- 10PMID 41255585PubMed
- 11PMID 41747885PubMed
- 12PMID 41207308PubMed