Cure8 trial brief
This trial tests whether adding an FXR agonist (LY4395089) to mirikizumab improves endoscopic response in people with moderate–severe Crohn's disease. Results could influence future combination treatment strategies and inform whether an oral FXR agonist adds benefit to IL-23–targeted biologic therapy.
Adults with moderately to severely active Crohn's disease, clinicians who treat IBD, clinical researchers in IBD drug development, and patients already on or considering IL-23–targeted therapy.
This ClinicalTrials.gov record describes a Phase 2, randomized interventional study comparing mirikizumab alone versus mirikizumab given together with an oral farnesoid X receptor (FXR) agonist, LY4395089, in adults with moderately to severely active Crohn's disease.
The trial is part of an IIBD master protocol, plans about 60 participants, lasts ~62 weeks, and measures endoscopic response at week 12 as a primary outcome.
The study includes two study periods: initial IV mirikizumab (with or without oral LY4395089) and, for responders, a period where responders transition to subcutaneous mirikizumab and stop LY4395089 if they were on the combination. Key exclusions include hepatic disease and recent major cardiovascular events. Multiple U.S.
sites are listed and the registry status is recruiting. If you are considering participation or advising patients, the protocol permits concurrent stable GLP-1 class therapies and has specific medication and safety exclusions; consult the full trial record and site staff for eligibility and safety details.
This is a Phase 2 interventional trial registered on ClinicalTrials.gov and listed as recruiting. The record provides study design, eligibility, intervention route (IV, SC, oral), primary endpoint (endoscopic response at week 12), and planned enrollment; it is not a report of results.
Refer to the full protocol and site investigators for detailed safety, consent, and participation information.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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