A Study of LY4395089 and Mirikizumab for Crohn's Disease

This study is looking at two medications for adults with moderately to severely active Crohn's disease (CD). Researchers want to see how safe and effective LY4395089 (taken by mouth) is when given along with Mirikizumab (given by IV or under the skin), compared to Mirikizumab alone. You may be able to join if you are between 18 and 80 years old and meet other specific health requirements. The main goal is to see how many participants achieve an endoscopic response (improvement seen during an endoscopy) by about 12 weeks. The study plans to enroll 60 people, but its current recruitment status is unclear. The study will last about 62 weeks.

Study design
This is an interventional study planning to enroll 60 adult participants. It is part of a larger master protocol.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured up to Week 12, and the study lasts approximately 62 weeks.

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NCT07483099

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

Recruiting
PHASE2Ages 18–80InterventionalTreatment
Eli Lilly and Company
~60 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:LY4395089Mirikizumab - Intravenous (IV)Mirikizumab - Subcutaneous (SC)

At a glance

Recruiting sites
26 of 70 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants with Crohn's Disease who Achieve Endoscopic Response
Measured over Baseline, Up to Week 12
Crohn Disease
70 sites across 20 states
Poland10
Brazil9
China9
Israel7
Italy6
Germany5
Belgium4
Canada3
  • Contact Lilly at 1-877-CTLILLY (1-877-285-4559) or · STUDY_DIRECTOR · Eli Lilly and Company
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Eligibility criteria

Inclusion

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

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
  • Percentage of Participants with Crohn's Disease who Achieve Endoscopic ResponseBaseline, Up to Week 12

    The percentage of participants who achieve endoscopic response at week 12 of Study Period 1.