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NCT07483099PHASE2Recruiting

A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease

Eli Lilly and Company

Start Date

5/4/2026

Completion Date

3/1/2028

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.

Eligibility Criteria

Age Range: 18 years to 80 years

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

Interventions

DRUG

LY4395089

DRUG

Mirikizumab - Intravenous (IV)

DRUG

Mirikizumab - Subcutaneous (SC)

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Conditions

Crohn Disease

Locations

Mayo Clinic in Arizona - Scottsdale

Scottsdale, Arizona 85259

United States

Biopharma Informatic, LLC

Los Angeles, California 90035

United States

Om Research LLC

Oxnard, California 93030

United States

South Denver Gastroenterology

Englewood, Colorado 80113

United States

Gastro Health Research - Miami

Miami, Florida 33176

United States

Ezy Medical Research

Miami Lakes, Florida 33015

United States

Atlanta Gastroenterology Associates - Peachtree Dunwoody

Atlanta, Georgia 30342

United States

Rush University Medical Center

Chicago, Illinois 60612

United States

Cotton O'Neil Digestive Health Center

Topeka, Kansas 66606

United States

Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center

Wyoming, Michigan 49519

United States

KAD Clinical Research

St Louis, Missouri 63123

United States

Vector Clinical Trials

Las Vegas, Nevada 89128

United States

Innovo Research - Wilmington Gastroenterology Associates

Wilmington, North Carolina 28403

United States

One of a Kind Clinical Research Center - Kingwood

Kingwood, Texas 77339

United States

Southern Star Research Institute

San Antonio, Texas 78229

United States

AZ Maria Middelares

Ghent, 9000

Belgium

UZ Gent

Ghent, 9000

Belgium

UZ Leuven

Leuven, 3000

Belgium

AZ Delta vzw

Roeselare, 8800

Belgium

Loema Instituto de Pesquisa Clinica

Campinas, 13092-133

Brazil

Fundação Universidade de Caxias do Sul (FUCS)

Caxias do Sul, 95070-560

Brazil

Centro Digestivo de Curitiba

Curitiba, 80430-180

Brazil

Centro de Pesquisa Clínica de Marília - CPCLIM

Marília, 17504-072

Brazil

CPHosp Medicina, Ensino e Pesquisa (CPQuali)

São Paulo, 01228-000

Brazil

CPCLIN

São Paulo, 01228-200

Brazil

BR Trials - Ensaios Clinicos e Consultoria

São Paulo, 01236030

Brazil

Clínica Hepatogastro JK

São Paulo, 04077-020

Brazil

CEDOES

Vitória, 29055450

Brazil

Prairie Institute of Liver and Luminal Advanced Research Ltd (PILLAR)

Lethbridge, T1J 4G9

Canada

London Digestive Disease Institute

London, N6K 1M6

Canada

Tdda Inc.

Vaughan, L4L 4Y7

Canada

The Second Xiangya Hospital of Central South University

Changsha, 410011

China

Changzhou Second People's Hospital

Changzhou, 213000

China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, 510080

China

The Second Affiliated hospital of Zhejiang University school of medicine

Hangzhou, 310052

China

Huizhou Central People's Hospital

Huizhou, 516001

China

The Second Affiliated Hospital of Soochow University

Suzhou, 215004

China

The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university

Wenzhou, 325000

China

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, 361000

China

Affiliated Hospital of Jiangsu University

Zhenjiang, 212000

China

Charité Universitaetsmedizin Berlin - Campus Mitte

Berlin, 10117

Germany

Studienzentrum MVZ Dachau

Dachau, 85221

Germany

Studiengesellschaft BSF Unternehmergesellschaft

Halle, 06108

Germany

St. Marien- und St. Annastiftskrankenhaus

Ludwigshafen, 67067

Germany

Universitaetsklinikum Ulm

Ulm, 89081

Germany

Geomedical Egészségügyi Központ

Budapest, 1066

Hungary

Semmelweis Egyetem

Budapest, 1082

Hungary

Komarom-Esztergom Varmegyei Szent Borbala Korhaz

Tatabánya, 2800

Hungary

Assuta Ashdod Medical Center

Ashdod, 7747629

Israel

Rambam Health Care Campus

Haifa, 3109601

Israel

Shaare Zedek Medical Center

Jerusalem, 9103102

Israel

Hadassah Medical Center

Jerusalem, 9112001

Israel

Rabin Medical Center

Petah Tikva, 4941492

Israel

Sheba Medical Center

Ramat Gan, 5262100

Israel

Yitzhak Shamir Medical Center

Ẕerifin, 7033001

Israel

Azienda Ospedaliera Universitaria Careggi

Florence, 50134

Italy

Ospedale San Raffaele

Milan, 20132

Italy

Fondazione IRCCS San Gerardo dei Tintori

Monza, 20900

Italy

Ospedale Sacro Cuore Don G. Calabria

Negrar, 37024

Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, 00168

Italy

Humanitas

Rozzano, 20089

Italy

Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero

Katowice, 40-600

Poland

Oslomed Centrum Medyczne

Krakow, 31-228

Poland

Medrise Sp. z o.o.

Lublin, 20-582

Poland

Twoja Przychodnia PCM

Poznan, 60-324

Poland

ETG Siedlce

Siedlce, 08-110

Poland

Twoja Przychodnia SCM

Szczecin, 71-434

Poland

Sonomed Sp. z o. o.

Szczecin, 71-685

Poland

WSD MEDI

Warsaw, 02-786

Poland

Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś

Warsaw, 04-501

Poland

ETG Zamość

Zamość, 22-400

Poland