LY4395089 Added to Mirikizumab Versus Mirikizumab Alone in Crohn's Disease
Compares LY4395089 plus mirikizumab with mirikizumab alone in adults with active Crohn's disease.
Plain-language title generated from the registry record
Registry title: A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease
Key facts
- Where
- Atlanta, Chicago, Englewood, Kingwood, Las Vegas, Los Angeles, Miami, Miami Lakes, Oxnard, San Antonio, Scottsdale, St Louis, Topeka, and Wyoming, United StatesSee the 14 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 United States
- Atlanta Gastroenterology Associates - Peachtree DunwoodyAtlanta, United StatesTaking people
- Rush University Medical CenterChicago, United StatesNot yet recruiting
- South Denver GastroenterologyEnglewood, United StatesTaking people
- One of a Kind Clinical Research Center - KingwoodKingwood, United StatesTaking people
- Vector Clinical TrialsLas Vegas, United StatesTaking people
- Biopharma Informatic LLCLos Angeles, United StatesNot yet recruiting
- Gastro Health Research - MiamiMiami, United StatesTaking people
- Ezy Medical ResearchMiami Lakes, United StatesTaking people
- OM Research LLCOxnard, United StatesTaking people
- Southern Star Research InstituteSan Antonio, United StatesTaking people
- Mayo Clinic in Arizona - ScottsdaleScottsdale, United StatesNo longer taking part
- KAD Clinical ResearchSt Louis, United StatesTaking people
- Cotton O'Neil Digestive Health CenterTopeka, United StatesTaking people
- Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research CenterWyoming, United StatesNot yet recruiting
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:.