Crohn Disease
LY4395089 Plus Mirikizumab Versus Mirikizumab for Crohn's Disease
This study is comparing the safety and efficacy of oral LY4395089 given with mirikizumab against mirikizumab alone in adults with moderately to severely active Crohn's disease.
Registry title: A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease
14 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–80 Years
- Treatment
- LY4395089 or Mirikizumab - Intravenous (IV)
- Design
- Randomized
- Central study contact
- There may be multiple sites in this clinical trial. (Add "This 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559clinical_inquiry_hub@lilly.com
- Sponsor
- Eli Lilly and Company
Research question
How do the safety and efficacy of LY4395089 plus mirikizumab compare with mirikizumab alone in adults with moderately to severely active Crohn's disease?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 80.
- The study is looking for people with moderately to severely active Crohn's disease.
- People of any sex may be considered; healthy volunteers are not accepted.
- Participants must meet applicable criteria from the separate IIBD master protocol as well as the criteria reported in this record.
Participation overview
What participation may involve
Participants receive either mirikizumab alone or oral LY4395089 with mirikizumab during Study Period 1. Responders in both groups receive subcutaneous mirikizumab during Study Period 2, and combination-group responders stop LY4395089. What participation may involve: - During Study Period 1, participants receive mirikizumab intravenously. - Participants assigned to the combination group also take LY4395089 orally during Study Period 1. - Responders receive mirikizumab by subcutaneous injection during Study Period 2. - Study assessments include endoscopic response, clinical remission, and fecal calprotectin. The registry states that the study will last approximately 62 weeks.
Study interventions
What participants may receive or do
- LY4395089: An oral drug given with intravenous mirikizumab during Study Period 1 in the experimental group. Responders stop LY4395089 in Study Period 2.
- Mirikizumab - Intravenous (IV): Mirikizumab administered into a vein during Study Period 1 in both study groups.
- Mirikizumab - Subcutaneous (SC): Mirikizumab administered under the skin during Study Period 2 to participants who responded in Study Period 1.
Study design
How the comparison works
This is a Phase 2, parallel-group study comparing LY4395089 plus mirikizumab with mirikizumab alone. The estimated enrollment is 60 participants. Participants are assigned randomly to one of the two study groups. The study is open-label, meaning the registry reports no masking. The active-control group receives mirikizumab without LY4395089. The registry describes an active-control group and does not describe a placebo or sham intervention.
Reported activities
Procedures and tests
- Endoscopic response is assessed from baseline through Week 12 as the primary outcome.
- Clinical remission is assessed from baseline through Week 12.
- Fecal calprotectin is measured from baseline through Week 12, which involves analysis of a stool sample.
- Mirikizumab is administered intravenously during Study Period 1.
- Responders receive mirikizumab by subcutaneous injection during Study Period 2.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must meet all applicable inclusion criteria in the IIBD master protocol, except criteria specific to ulcerative colitis.
- Participants must be ages 18 through 80.
- The study population is adults with moderately to severely active Crohn's disease.
- People taking listed GLP-1-related medicines for approved uses may enroll if their dose is stable at screening.
Possible reasons someone may not be able to join
- Anyone meeting an applicable exclusion criterion in the IIBD master protocol, other than criteria specific to ulcerative colitis, is excluded.
- Participants must not have hepatic disease.
- Participants must not have a history of another bone disease that affects bone metabolism.
- Participants must not have had an acute myocardial infarction or cerebrovascular incident within 180 days before screening.
- Participants must not have been hospitalized for unstable angina or congestive heart failure within 180 days before screening.
- Participants must not have undergone coronary revascularization within 180 days before screening.
- Participants must not have received, or expect to need, another medication prohibited by the protocol.
Important unknowns
What the record does not make clear
- This record refers to additional inclusion and exclusion criteria in the IIBD master protocol but does not reproduce them.
- The number, timing, and length of study visits are not reported.
- The record does not explain which existing Crohn's disease treatments may continue during the study.
- The record excludes prohibited medications but does not identify them or state any washout periods.
- The record does not state what treatment is available if Crohn's disease worsens during the study.
- Endoscopic response is the primary outcome, but the record does not describe the endoscopy schedule, preparation, sedation, or related procedures.
- The record does not explain which study-related or routine-care costs are covered or billed to insurance.
- The record does not report whether participants are compensated.
- The record does not report whether travel, lodging, meals, or parking are reimbursed.
- The record does not state whether any visits or assessments can occur remotely or locally.
- The record does not describe access to study drugs after participation ends.
- The overall study is recruiting, but listed locations have differing statuses, including recruiting, not yet recruiting, and suspended.
Before contacting the site
Questions for the study team
- What additional inclusion and exclusion criteria from the IIBD master protocol apply to this study?
- How many visits, infusions, injections, stool collections, and endoscopies are required across the approximately 62 weeks?
- Which current Crohn's disease medicines can continue, which are prohibited, and are washout periods required?
- What happens if my Crohn's disease worsens or I do not respond during either study period?
- What side effects and monitoring are specifically associated with LY4395089, mirikizumab, and their co-administration?
- Which study-related costs are covered, and are compensation or travel reimbursements available?
- Is the site nearest me actively enrolling, and can any visits or tests be completed locally or remotely?
Before changing care
Questions for your gastroenterologist
- How might this study affect the timing or continuation of my current Crohn's disease treatments?
- How stable is my Crohn's disease now, and what clinical concerns would matter before considering a randomized study of these regimens?
- What approved treatment alternatives should I understand alongside this study?
- Are there liver, bone, or cardiovascular issues in my history that I should discuss with the research team?
- How should you and the research team coordinate disease monitoring and care if my symptoms worsen?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
Study design and administration
- Organization
- Eli Lilly and Company
- Organization class
- Industry
- Organization study ID
- 27810
- Lead sponsor
- Eli Lilly and Company
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Active Comparator
Mirikizumab
Study Period 1: Mirikizumab administered via IV. Study Period 2: Responders will receive mirikizumab SC.
Interventions: Drug: Mirikizumab - Intravenous (IV), Drug: Mirikizumab - Subcutaneous (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: Drug: LY4395089, Drug: Mirikizumab - Intravenous (IV), Drug: Mirikizumab - Subcutaneous (SC)
Interventions
Drug
LY4395089
Administered orally
Drug
Mirikizumab - Intravenous (IV)
Administered IV
Drug
Mirikizumab - Subcutaneous (SC)
Administered SC
Eligibility
18 Years–80 Years
All
Not accepted
Inclusion criteria (1)
- 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 screeningRegistry-derived · unreviewed
Exclusion criteria (10)
- 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:Registry-derived · unreviewed
- Must not have a hepatic diseaseRegistry-derived · unreviewed
- Must not have a history of any other bone disease that affects bone metabolismRegistry-derived · unreviewed
- Must not have had any of the following within the past 180 days before screening:Registry-derived · unreviewed
- acute myocardial infarctionRegistry-derived · unreviewed
- cerebrovascular incidentRegistry-derived · unreviewed
- hospitalization for unstable anginaRegistry-derived · unreviewed
- hospitalization due to congestive heart failure, orRegistry-derived · unreviewed
- coronary revascularizationRegistry-derived · unreviewed
- Must not have received or will need any other prohibited medications as specified in the protocolRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Percentage of Participants with Crohn's Disease who Achieve Endoscopic Response
Time frame: Baseline, Up to Week 12
The percentage of participants who achieve endoscopic response at week 12 of Study Period 1.
Secondary outcome
Percentage of Participants who Achieve Clinical Remission
Time frame: Baseline, Up to Week 12
Secondary outcome
Percent Change from Baseline in Fecal Calprotectin
Time frame: Baseline, Up to Week 12
Recruiting locations in the United States
Mayo Clinic in Arizona - Scottsdale
Not Yet RecruitingScottsdale, Arizona, 85259, United States
Manreet Kaur
Biopharma Informatic, LLC
Not Yet RecruitingLos Angeles, California, 90035, United States
Morris Silver, MD
Om Research LLC
RecruitingOxnard, California, 93030, United States
Karen Simon
South Denver Gastroenterology
RecruitingEnglewood, Colorado, 80113, United States
Marcelo Kugelmas
Gastro Health Research - Miami
RecruitingMiami, Florida, 33176, United States
Lukasz Kwapisz
Ezy Medical Research
RecruitingMiami Lakes, Florida, 33015, United States
Hendry Perez-Pascual
Atlanta Gastroenterology Associates - Peachtree Dunwoody
RecruitingAtlanta, Georgia, 30342, United States
Nitin Gupta
Rush University Medical Center
Not Yet RecruitingChicago, Illinois, 60612, United States
Atsushi Sakuraba
Cotton O'Neil Digestive Health Center
RecruitingTopeka, Kansas, 66606, United States
Curtis Baum
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
Not Yet RecruitingWyoming, Michigan, 49519, United States
Allan Coates
KAD Clinical Research
RecruitingSt Louis, Missouri, 63123, United States
Adrian Di Bisceglie
Vector Clinical Trials
RecruitingLas Vegas, Nevada, 89128, United States
Christian Stone
One of a Kind Clinical Research Center - Kingwood
Not Yet RecruitingKingwood, Texas, 77339, United States
Sushovan Guha
Southern Star Research Institute
RecruitingSan Antonio, Texas, 78229, United States
Jeff Bullock
This study also lists 56 locations outside the United States. They are not shown here.
Central study contacts
There may be multiple sites in this clinical trial. (Add "This 1-877-CTLILLY (1-877-285-4559) or
Contact
Registry dates
- First posted
- Mar 19, 2026
- Primary completion
- Jun 2027
- Overall completion
- Mar 2028
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.