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A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease

RecruitingPhase 2Ages 18 Years - 80 YearsAllEli Lilly and Company
NCT07483099 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • LY4395089
  • Mirikizumab - Intravenous (IV)
  • Mirikizumab - Subcutaneous (SC)
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Where

70 sites
Mayo Clinic in Arizona - Scottsdale
Scottsdale, United States
Biopharma Informatic, LLC
Los Angeles, United States
Om Research LLC
Oxnard, United States
South Denver Gastroenterology
Englewood, United States
Gastro Health Research - Miami
Miami, United States
Ezy Medical Research
Miami Lakes, United States
Atlanta Gastroenterology Associates - Peachtree Dunwoody
Atlanta, United States
Rush University Medical Center
Chicago, United States

…and 62 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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