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
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
- DrugLY4395089
Administered orally
- DrugMirikizumab - Intravenous (IV)
Administered IV
- DrugMirikizumab - Subcutaneous (SC)
Administered SC
Locations (72)
- Mayo Clinic in Arizona - ScottsdaleScottsdale, Arizona
- Biopharma Informatic, LLCLos Angeles, California
- Om Research LLCOxnard, California
- South Denver GastroenterologyEnglewood, Colorado
- Gastro Health Research - MiamiMiami, Florida
- Ezy Medical ResearchMiami Lakes, Florida