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

In plain English

What this trial is testing

This study is testing LY4395089 (a drug), Mirikizumab - Intravenous (IV) (a drug) and Mirikizumab - Subcutaneous (SC) (a drug) as a possible treatment. Condition(s) listed: Crohn Disease.

Participants are assigned to groups by chance (randomized).

It is open-label: participants know what they are receiving.

Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.

Who can join

• Ages 18 to 80
• Any sex

Some of the main requirements, copied from the record:

• 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…

There are also 10 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 60 participants are expected to take part.
• The study has 2 groups.
• Start date: 2026-05-04.
• Main results expected around 2027-06 (estimate from the record).
• 70 study sites listed (42 marked recruiting) in Belgium, Brazil, Canada, China and Germany and 5 more countries.

Groups in this study

• Mirikizumab (listed as: active comparator group)
• LY4395089 and Mirikizumab Co-Administration (listed as: experimental group)

Main thing being measured

• Percentage of Participants with Crohn's Disease who Achieve Endoscopic Response (Baseline, Up to Week 12)

In the researchers’ words

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.

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.