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LY4395089

Phase 2

Crohn Disease | Small molecule | Gastrointestinal |Eli Lilly and Company|Last Updated: Aug 25, 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

Clinical trial landscape

LY4395089 · 2 trials · 2 indications

Phase 2 1Phase 1 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.

Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from 0 to infinity (AUC[0-∞]) of LY4395089
Baseline up to Day 15
PK: Maximum Concentration (Cmax) of LY4395089
Baseline up to Day 15

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.
LY4395089EXPERIMENTALLY4395089 administered orally
ItraconazoleEXPERIMENTALItraconazole administered orally
LY4395089 + ItraconazoleEXPERIMENTALLY4395089 and Itraconazole administered orally

Interventions

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

HIGHAug 25, 2026NCT07592572Status: RECRUITING → COMPLETED
HIGHAug 25, 2026NCT07592572Status: RECRUITING → COMPLETED
LOWAug 24, 2026NCT07483099lastUpdatePostDate: changed
LOWAug 24, 2026NCT07483099lastUpdatePostDate: changed
LOWAug 6, 2026NCT07483099lastUpdatePostDate: changed
LOWAug 6, 2026NCT07483099lastUpdatePostDate: changed
LOWJul 17, 2026NCT07483099lastUpdatePostDate: changed
LOWJul 17, 2026NCT07483099lastUpdatePostDate: changed
LOWJul 7, 2026NCT07483099lastUpdatePostDate: changed
LOWJul 7, 2026NCT07483099lastUpdatePostDate: changed
LOWJun 16, 2026NCT07592572Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 16, 2026NCT07592572Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 16, 2026NCT07592572Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about LY4395089

What is LY4395089 used for in Crohn's disease?

LY4395089 is an investigational small molecule being studied for Crohn's disease. It is currently in Phase 2 clinical development, evaluated in combination with mirikizumab (LY3074828) compared to mirikizumab alone in adults with Crohn's disease. The drug is not approved and remains under investigation.

What does LY4395089 target?

The molecular target of LY4395089 has not been disclosed in available clinical trial information. The drug is a small molecule being developed by Eli Lilly and Company for gastrointestinal conditions, specifically Crohn's disease. Its mechanism of action is not publicly detailed in the current trial data.

Who makes LY4395089?

LY4395089 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker LLY. The company is conducting clinical trials of LY4395089 for Crohn's disease and in healthy participants.

What phase is LY4395089 in?

LY4395089 is in Phase 2 clinical development for Crohn's disease. A Phase 1 study in healthy participants has been completed. The drug is investigational and has not been approved by regulatory authorities. Its safety and efficacy are still being evaluated in clinical trials.

What clinical trials is LY4395089 in?

LY4395089 is being studied in two clinical trials. NCT07483099 is a Phase 2 study in adults with Crohn's disease, comparing LY4395089 plus mirikizumab to mirikizumab alone, currently recruiting in multiple countries. NCT07592572 is a completed Phase 1 study of itraconazole's effects on LY4395089 in healthy participants.

Is LY4395089 the same as mirikizumab?

No, LY4395089 is not the same as mirikizumab. Mirikizumab, also known as LY3074828, is a separate drug developed by Eli Lilly. In a Phase 2 trial, LY4395089 is being tested in combination with mirikizumab, and the study compares this combination to mirikizumab alone in Crohn's disease.