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Phase 2Recruiting

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

Sponsored by Eli Lilly and Company

About this 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.

Where this study is enrolling (2)

  • Atlanta Gastroenterology Associates - Peachtree Dunwoody

    Atlanta, Georgia

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  • Rush University Medical Center

    Chicago, Illinois

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Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.