Recruiting
Phase 2

FXR Agonist & Mirikizumab

Sponsor:

Eli Lilly and Company

Code:

NCT07483099

Conditions

Crohn Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

LY4395089

Mirikizumab - Intravenous (IV)

Mirikizumab - Subcutaneous (SC)

Study Details

Brief summary:

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.

Conditions

Crohn Disease

Study ID

NCT07483099

Start date

May 4, 2026

Status verified date

Aug, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Mirikizumab

Study Period 1: Mirikizumab administered via IV. Study Period 2: Responders will receive mirikizumab SC.

experimental: LY4395089 and Mirikizumab Co-Administration

Study Period 1: Co-administration of LY4395089 administered orally and mirikizumab administered IV.

Study Period 2: Responders will stop LY4395089 and receive mirikizumab SC.

Interventions

LY4395089

Administered orally

Mirikizumab - Intravenous (IV)

Administered IV

Mirikizumab - Subcutaneous (SC)

Administered SC

Primary outcome measure

  • Percentage of Participants with Crohn's Disease who Achieve Endoscopic Response [ Time Frame: Baseline, Up to Week 12 ]

Central Contacts and Locations

Central contacts

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

1-317-615-4559clinical_inquiry_hub@lilly.com

Locations

Om Research LLC

Recruiting

Oxnard, California, United States, 93030

Principal Investigator:

Karen Simon

South Denver Gastroenterology

Recruiting

Englewood, Colorado, United States, 80113

Principal Investigator:

Marcelo Kugelmas

Gastro Health Research - Miami

Recruiting

Miami, Florida, United States, 33176

Principal Investigator:

Lukasz Kwapisz

Ezy Medical Research

Recruiting

Miami Lakes, Florida, United States, 33015

Principal Investigator:

Hendry Perez-Pascual

Atlanta Gastroenterology Associates - Peachtree Dunwoody

Recruiting

Atlanta, Georgia, United States, 30342

Principal Investigator:

Nitin Gupta

Cotton O'Neil Digestive Health Center

Recruiting

Topeka, Kansas, United States, 66606

Principal Investigator:

Curtis Baum

KAD Clinical Research

Recruiting

St Louis, Missouri, United States, 63123

Principal Investigator:

Adrian Di Bisceglie

Vector Clinical Trials

Recruiting

Las Vegas, Nevada, United States, 89128

Principal Investigator:

Christian Stone

Southern Star Research Institute

Recruiting

San Antonio, Texas, United States, 78229

Principal Investigator:

Jeff Bullock

Tdda Inc.

Recruiting

Vaughan, Canada, L4L 4Y7

Principal Investigator:

David Ford

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-24.