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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Eli Lilly and Company • ClinicalTrials.gov ID: NCT07483099

Registry updated: 2026-10-08
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Description

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.

Interventions

  • LY4395089 (Drug)
    Administered orally
  • Mirikizumab - Intravenous (IV) (Drug)
    Administered IV
  • Mirikizumab - Subcutaneous (SC) (Drug)
    Administered SC

Eligibility criteria

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

Conditions

Crohn Disease

Locations

  • 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
  • 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 Mitteldeutschland GmbH — 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
  • Centrum Medyczne Oslomed — 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record