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RecruitingPhase 2

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

Eli Lilly and Company · NCT07483099

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–80 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
60
US sites recruiting
10
Study start
May 4, 2026
Record last updated
October 8, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: LY4395089; Mirikizumab - Intravenous (IV); Mirikizumab - Subcutaneous (SC)

Conditions: Crohn Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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 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

Recruiting US locations

  • Om Research LLC

    Oxnard, CA 93030

    Site contact: Karen Simon

  • South Denver Gastroenterology

    Englewood, CO 80113

    Site contact: Marcelo Kugelmas

  • Gastro Health Research - Miami

    Miami, FL 33176

    Site contact: Lukasz Kwapisz

  • Ezy Medical Research

    Miami Lakes, FL 33015

    Site contact: Hendry Perez-Pascual

  • Atlanta Gastroenterology Associates - Peachtree Dunwoody

    Atlanta, GA 30342

    Site contact: Nitin Gupta

  • Cotton O'Neil Digestive Health Center

    Topeka, KS 66606

    Site contact: Curtis Baum

  • KAD Clinical Research

    St Louis, MO 63123

    Site contact: Adrian Di Bisceglie

  • Vector Clinical Trials

    Las Vegas, NV 89128

    Site contact: Christian Stone

  • One of a Kind Clinical Research Center - Kingwood

    Kingwood, TX 77339

    Site contact: Sushovan Guha

  • Southern Star Research Institute

    San Antonio, TX 78229

    Site contact: Jeff Bullock

Study contacts (from the official record)

  • 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
A Study of LY4395089 and Mirikizumab (LY3074828) Given Together… (NCT07483099) | Bored Studies