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A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease
A Phase 2, Multicenter, Randomized, Open-Label, Active-Controlled Study to Investigate LY4395089/Mirikizumab Co-administration Compared With Mirikizumab in Adults With Moderately to Severely Active Crohn's Disease
Who can join
Ages 18 to 80 · All sexes
Full eligibility criteria
Inclusion Criteria: Participants must meet all the inclusion criteria in the IIBD master protocol, except the UC-specific criteria. In addition, they must meet the criteria below: * Participants taking glucagon-like peptide-1 (GLP-1) receptor agonists (RAs), GLP-1/glucose-dependent insulinotropic polypeptide (GIP) RAs, GLP-1/glucagon (Gcg) RAs, GLP-1/GIP/Gcg RAs, or similar medications for approved indications will be permitted to enroll provided they are on a stable dose at the time of screening Exclusion Criteria: Participants are excluded from the study if any of the exclusion criteria in the IIBD master protocol, except the UC-specific criteria apply, or if any of the following criteria apply: * Must not have a hepatic disease * Must not have a history of any other bone disease that affects bone metabolism * Must not have had any of the following within the past 180 days before screening: * acute myocardial infarction * cerebrovascular incident * hospitalization for unstable angina * hospitalization due to congestive heart failure, or * coronary revascularization * Must not have received or will need any other prohibited medications as specified in the protocol
About the study
The main purpose of this study is to see how the safety and efficacy of a farnesoid X receptor (FXR) agonist (LY4395089), given together with mirikizumab compares with mirikizumab (alone) in adults with moderately to severely active Crohn's disease (CD). This study is part of the IIBD master protocol and will last approximately 62 weeks.
What is being tested
- LY4395089 (drug)
- Mirikizumab - Intravenous (IV) (drug)
- Mirikizumab - Subcutaneous (SC) (drug)
Sponsor: Eli Lilly and Company · Participants: 60 · Started: May 4, 2026
Contact the study team
- There may be multiple sites in this clinical trial. (Add "This 1-877-CTLILLY (1-877-285-4559) or · Phone: 1-317-615-4559
Official record on ClinicalTrials.gov — NCT07483099
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.