Flu? No—A combination of an FXR activator and mirikizumab for adults with Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, interventional trial within the IIBD master protocol. Adults with moderately to severely active Crohn's disease will receive LY4395089 in combination with mirikizumab and compare outcomes to mirikizumab alone. The study includes both IV and SC administration of mirikizumab and LY4395089, with follow-up expected to last about 62 weeks. Eligibility largely follows the IIBD protocol, with some allowances for concurrent GLP-1 related therapies and specific exclusions related to liver and bone conditions. Primary aims center on safety and efficacy of the combination treatment.

Why it matters

Who can join: the full rules

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 in the IIBD master protocol, except the UC-specific criteria apply, or if any of the following criteria apply:

* 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

Where it's running

• Om Research LLC
  Oxnard, California, United States Recruiting
• South Denver Gastroenterology
  Englewood, Colorado, United States Recruiting
• Gastro Health Research - Miami
  Miami, Florida, United States Recruiting
• Ezy Medical Research
  Miami Lakes, Florida, United States Recruiting
• Atlanta Gastroenterology Associates - Peachtree Dunwoody
  Atlanta, Georgia, United States Recruiting
• Cotton O'Neil Digestive Health Center
  Topeka, Kansas, United States Recruiting

+21 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: There may be multiple sites in this clinical trial. (Add "This 1-877-CTLILLY (1-877-285-4559) or
• Email: clinical_inquiry_hub@lilly.com
• Phone: 1-317-615-4559

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Risankizumab for Refractory Perianal Fistulizing Crohn's Disease

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• Intestinal ultrasound-guided management for inflammatory bowel disease

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• Laser-based sizing of GI lesions during endoscopies

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• A Probiotic Approach to Modulating Gut Microbiota in Mild-to-Moderate Ulcerative Colitis

  A specific probiotic given rectally will be tested in adults with mild-to-moderate ulcerative colitis to see if it can help manage symptoms.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.