A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease
Key facts
- Where
- Greenfield Park, Lethbridge, London, and Vaughan, CanadaSee the 4 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07483099, who can take part
Where in Canada
- Centre Intégré de Santé et de Services Sociaux de la Montérégie-CentreGreenfield Park, CanadaNot yet recruiting
- Prairie Institute of Liver and Luminal Advanced Research Ltd (PILLAR)Lethbridge, CanadaNot yet recruiting
- London Digestive Disease InstituteLondon, CanadaNot yet recruiting
- Tdda Inc.Vaughan, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07483099
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; Must not have a hepatic disease; Must not have a history of any other bone disease that affects bone metabolism; 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:.