RecruitingPhase 2NCT07483099

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

A Phase 2, Multicenter, Randomized, Open-Label, Active-Controlled Study to Investigate LY4395089/Mirikizumab Co-administration Compared With Mirikizumab in Adults With Moderately to Severely Active Crohn's Disease

Sponsor

Eli Lilly and Company

Enrollment

60 participants

Start Date

May 4, 2026

Study Type

INTERVENTIONAL

Conditions

Crohn Disease

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called LY4395089, a drug called Mirikizumab - Intravenous (IV), and others for people with crohn disease. The study is currently recruiting participants at 72 locations. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLY4395089

Administered orally

DRUGMirikizumab - Intravenous (IV)

Administered IV

DRUGMirikizumab - Subcutaneous (SC)

Administered SC

Locations(71)

Mayo Clinic in Arizona - Scottsdale

Scottsdale, Arizona, United States

Biopharma Informatic, LLC

Los Angeles, California, United States

Om Research LLC

Oxnard, California, United States

South Denver Gastroenterology

Englewood, Colorado, United States

Gastro Health Research - Miami

Miami, Florida, United States

Ezy Medical Research

Miami Lakes, Florida, United States

Atlanta Gastroenterology Associates - Peachtree Dunwoody

Atlanta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Cotton O'Neil Digestive Health Center

Topeka, Kansas, United States

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

Wyoming, Michigan, United States

KAD Clinical Research

St Louis, Missouri, United States

Vector Clinical Trials

Las Vegas, Nevada, United States

Innovo Research - Wilmington Gastroenterology Associates

Wilmington, North Carolina, United States

One of a Kind Clinical Research Center - Kingwood

Kingwood, Texas, United States

Southern Star Research Institute

San Antonio, Texas, United States

AZ Maria Middelares

Ghent, Belgium

UZ Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

AZ Delta vzw

Roeselare, Belgium

Loema Instituto de Pesquisa Clinica

Campinas, Brazil

Fundação Universidade de Caxias do Sul (FUCS)

Caxias do Sul, Brazil

Centro Digestivo de Curitiba

Curitiba, Brazil

Centro de Pesquisa Clínica de Marília - CPCLIM

Marília, Brazil

CPHosp Medicina, Ensino e Pesquisa (CPQuali)

São Paulo, Brazil

CPCLIN

São Paulo, Brazil

BR Trials - Ensaios Clinicos e Consultoria

São Paulo, Brazil

Clínica Hepatogastro JK

São Paulo, Brazil

CEDOES

Vitória, Brazil

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

Lethbridge, Canada

London Digestive Disease Institute

London, Canada

Tdda Inc.

Vaughan, Canada

The Second Xiangya Hospital of Central South University

Changsha, China

Changzhou Second People's Hospital

Changzhou, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, China

The Second Affiliated hospital of Zhejiang University school of medicine

Hangzhou, China

Huizhou Central People's Hospital

Huizhou, China

The Second Affiliated Hospital of Soochow University

Suzhou, China

The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university

Wenzhou, China

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, China

Affiliated Hospital of Jiangsu University

Zhenjiang, China

Charité Universitaetsmedizin Berlin - Campus Mitte

Berlin, Germany

Studienzentrum MVZ Dachau

Dachau, Germany

Studiengesellschaft BSF Unternehmergesellschaft

Halle, Germany

St. Marien- und St. Annastiftskrankenhaus

Ludwigshafen, Germany

Universitaetsklinikum Ulm

Ulm, Germany

Geomedical Egészségügyi Központ

Budapest, Hungary

Semmelweis Egyetem

Budapest, Hungary

Komarom-Esztergom Varmegyei Szent Borbala Korhaz

Tatabánya, Hungary

Assuta Ashdod Medical Center

Ashdod, Israel

Rambam Health Care Campus

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Hadassah Medical Center

Jerusalem, Israel

Rabin Medical Center

Petah Tikva, Israel

Sheba Medical Center

Ramat Gan, Israel

Yitzhak Shamir Medical Center

Ẕerifin, Israel

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

Ospedale San Raffaele

Milan, Italy

Fondazione IRCCS San Gerardo dei Tintori

Monza, Italy

Ospedale Sacro Cuore Don G. Calabria

Negrar, Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, Italy

Humanitas

Rozzano, Italy

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

Katowice, Poland

Oslomed Centrum Medyczne

Krakow, Poland

Medrise Sp. z o.o.

Lublin, Poland

Twoja Przychodnia PCM

Poznan, Poland

ETG Siedlce

Siedlce, Poland

Twoja Przychodnia SCM

Szczecin, Poland

Sonomed Sp. z o. o.

Szczecin, Poland

WSD MEDI

Warsaw, Poland

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

Warsaw, Poland

ETG Zamość

Zamość, Poland

View Full Details on ClinicalTrials.gov

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NCT07483099

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