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

Eli Lilly and Company

Summary

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.

Eligibility

Age range: 18–80 years
Sex: All
Healthy volunteers: No

Detailed 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…

Interventions

Drug
LY4395089
Administered orally
Drug
Mirikizumab - Intravenous (IV)
Administered IV
Drug
Mirikizumab - Subcutaneous (SC)
Administered SC

Summary

Eligibility

Interventions

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