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LY4395089 and Mirikizumab for Crohn's Disease

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

Recruiting Phase 2 Interventional Study
Crohn Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for

This trial is looking for adults with moderately to severely active Crohn's disease. Participants will receive either LY4395089 with mirikizumab or mirikizumab alone over approximately 62 weeks.

Are You a Good Fit for This Trial?
Must be taking GLP-1 receptor agonists

You may be able to join if

  • I have Crohn's disease
  • I am on a stable dose of certain approved medications

You may not be able to join if

  • I have a liver disease
  • I have a history of bone disease affecting bone metabolism
  • I have had a heart attack in the past 6 months
  • I have had a stroke in the past 6 months
  • I have been hospitalized for unstable angina in the past 6 months
  • I have been hospitalized for heart failure in the past 6 months
  • I have had coronary revascularization in the past 6 months
  • I am taking certain prohibited medications

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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.

Trial Locations

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Eligibility 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 …
Contacts

There may be multiple sites in this clinical trial. (Add "This 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

clinical_inquiry_hub@lilly.com

CONTACT

NCT ID: NCT07483099 Source: ClinicalTrials.gov