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LY4395089

Phase 2

Crohn Disease | Small molecule | Gastrointestinal |Eli Lilly and Company|Trials Updated: Oct 8, 2026

LY4395089 development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since Mar 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

LY4395089 clinical trials

LY4395089 · 1 trial · 1 indication

Phase 2 1
NCT07483099A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's DiseaseCrohn Disease
RECRUITING60 Analytics
PHASE2RECRUITING
A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease
Crohn DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants with Crohn's Disease who Achieve Endoscopic Response
Baseline, Up to Week 12

The percentage of participants who achieve endoscopic response at week 12 of Study Period 1.

Secondary Endpoints

Percentage of Participants who Achieve Clinical Remission
Baseline, Up to Week 12
Percent Change from Baseline in Fecal Calprotectin
Baseline, Up to Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MirikizumabACTIVE_COMPARATORStudy Period 1: Mirikizumab administered via IV. Study Period 2: Responders will receive mirikizumab SC.
LY4395089 and Mirikizumab Co-AdministrationEXPERIMENTALStudy Period 1: Co-administration of LY4395089 administered orally and mirikizumab administered IV. Study Period 2: Responders will stop LY4395089 and receive mirikizumab SC.

Interventions

NameTypeDescription
LY4395089DRUGAdministered orally
Mirikizumab - Intravenous (IV)DRUGAdministered IV
Mirikizumab - Subcutaneous (SC)DRUGAdministered SC
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites70

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 ...

Countries:United StatesBelgiumBrazilCanadaChinaGermanyHungaryIsraelItalyPoland
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Recent Changes (Last 90 Days)

LOWOct 8, 2026NCT07483099lastUpdatePostDate: changed
LOWOct 8, 2026NCT07483099lastUpdatePostDate: changed
LOWSep 22, 2026NCT07483099lastUpdatePostDate: changed
LOWSep 22, 2026NCT07483099lastUpdatePostDate: changed
LOWSep 8, 2026NCT07483099lastUpdatePostDate: changed
LOWSep 8, 2026NCT07483099lastUpdatePostDate: changed
LOWAug 24, 2026NCT07483099lastUpdatePostDate: changed
LOWAug 24, 2026NCT07483099lastUpdatePostDate: changed
LOWAug 6, 2026NCT07483099lastUpdatePostDate: changed
LOWAug 6, 2026NCT07483099lastUpdatePostDate: changed

Frequently asked questions about LY4395089

What is LY4395089 used for in Crohn Disease?

LY4395089 is an investigational small molecule being studied for the treatment of Crohn disease, a chronic inflammatory bowel condition. It is in Phase 2 clinical development and is being evaluated in adults with Crohn disease. Eli Lilly and Company is developing the drug, and it is not yet approved for any indication.

Who is developing LY4395089?

LY4395089 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. The company is the sponsor of the Phase 2 clinical program evaluating the drug in Crohn disease.

What phase is LY4395089 in?

LY4395089 is in Phase 2 clinical development. It is an investigational small molecule and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 2 trial is currently recruiting participants.

What clinical trials is LY4395089 in?

LY4395089 is being studied in one Phase 2 clinical trial, NCT07483099, titled A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease. The trial is recruiting and plans to enroll 60 adults across the United States, Belgium, Brazil, Canada, China, Germany, Hungary, Israel, Italy, and Poland.

Is LY4395089 combined with mirikizumab in clinical trials?

Yes. The Phase 2 trial NCT07483099 evaluates LY4395089 given together with mirikizumab (LY3074828) and mirikizumab alone in adults with Crohn disease. The study is active-controlled, randomized, and recruiting, with an estimated enrollment of 60 participants.