NCT07483099

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DRUG	LY4395089	Administered orally
DRUG	Mirikizumab - Intravenous (IV)	Administered IV
DRUG	Mirikizumab - Subcutaneous (SC)	Administered SC

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-06-01
• Completion: 2028-03-01
• First posted: 2026-03-19
• Last updated: 2026-03-19

Locations

72 sites across 10 countries: United States, Belgium, Brazil, Canada, China, Germany, Hungary, Israel, Italy, Poland

Regulatory

• FDA-regulated drug study