NCT07483099 · Eli Lilly and Company
A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease
What this study is about
The main purpose of this study is to see how the safety and effectiveness 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Scottsdale, Arizona
- Los Angeles, California
- Oxnard, California
- Englewood, Colorado
- Miami, Florida
- Miami Lakes, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Topeka, Kansas
- Wyoming, Michigan
- St Louis, Missouri
- Las Vegas, Nevada
And 3 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations