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

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Drug: Mirikizumab - Intravenous (IV); Drug: Mirikizumab - Subcutaneous (SC); Drug: LY4395089

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: There may be multiple sites in this clinical trial. (Add "This 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: clinical_inquiry_hub@lilly.com

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Not yet recruiting
    • Uz Gent
    • Principal Investigator: Jeroen Geldof
  • Ghent, Belgium, 9000
    • Not yet recruiting
    • AZ Maria Middelares
    • Principal Investigator: Didier Baert
  • Leuven, Belgium, 3000
    • Not yet recruiting
    • UZ Leuven
    • Principal Investigator: Bram Verstockt
  • Roeselare, Belgium, 8800
    • Not yet recruiting
    • AZ Delta VZW
    • Principal Investigator: Filip Baert
• Brazil
  • Campinas, Brazil, 13092-133
    • Not yet recruiting
    • Loema Instituto de Pesquisa Clinica
    • Principal Investigator: Joaquim Simoes Neto
  • Caxias do Sul, Brazil, 95070-560
    • Not yet recruiting
    • Fundação Universidade de Caxias do Sul (FUCS)
    • Principal Investigator: Eduardo Brambilla
  • Curitiba, Brazil, 80430-180
    • Not yet recruiting
    • Centro Digestivo de Curitiba
    • Principal Investigator: Odery Ramos Júnior
  • Marília, Brazil, 17504-072
    • Not yet recruiting
    • Centro de Pesquisa Clínica de Marília - CPCLIM
    • Principal Investigator: FABIO TEIXEIRA
  • São Paulo, Brazil, 01228-200
    • Not yet recruiting
    • CPCLIN
    • Principal Investigator: Adolpho Alexander da Silva
  • São Paulo, Brazil, 01228-000
    • Not yet recruiting
    • CPHosp Medicina, Ensino e Pesquisa (CPQuali)
    • Principal Investigator: Rafael Lages
  • São Paulo, Brazil, 01307-002
    • Not yet recruiting
    • Solare Trials
    • Principal Investigator: Marjorie Argollo
  • São Paulo, Brazil, 01236030
    • Not yet recruiting
    • Br Trials - Ensaios Clínicos e Consultoria
    • Principal Investigator: Roberto da Silva
  • São Paulo, Brazil, 04077-020
    • Not yet recruiting
    • Clínica Hepatogastro JK
    • Principal Investigator: Rodrigo Andrey Rocco
  • Vitória, Brazil, 29055450
    • Not yet recruiting
    • CEDOES
    • Principal Investigator: Felipe Ferreira
• Canada
  • Lethbridge, Canada, T1J 4G9
    • Not yet recruiting
    • Prairie Institute of Liver and Luminal Advanced Research Ltd (PILLAR)
    • Principal Investigator: Kaleb Marr
  • London, Canada, N6K 1M6
    • Not yet recruiting
    • London Digestive Disease Institute
    • Principal Investigator: Vipul Jairath
  • Vaughan, Canada, L4L 4Y7
    • Not yet recruiting
    • Tdda Inc.
    • Principal Investigator: David Ford
• China
  • Changsha, China, 410011
    • Not yet recruiting
    • The Second Xiangya Hospital Of Central South University
    • Principal Investigator: Xuehong Wang
  • Changzhou, China, 213000
    • Not yet recruiting
    • Changzhou Second People's Hospital
    • Principal Investigator: Wenjia LIU
  • Guangzhou, China, 510080
    • Not yet recruiting
    • The First Affiliated Hospital, Sun Yat-sen University
    • Principal Investigator: Baili Chen
  • Hangzhou, China, 310052
    • Not yet recruiting
    • The Second Affiliated Hospital of Zhejiang University School of Medicine
    • Principal Investigator: Yan Chen
  • Huizhou, China, 516001
    • Not yet recruiting
    • Huizhou Central People's Hospital
    • Principal Investigator: Huixin Chen
  • Suzhou, China, 215004
    • Not yet recruiting
    • The Second Affiliated Hospital of Soochow University
    • Principal Investigator: Wen Tang
  • Wenzhou, China, 325000
    • Not yet recruiting
    • The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
    • Principal Investigator: yi Jiang
  • Xiamen, China, 361000
    • Not yet recruiting
    • Zhongshan Hospital Affiliated to Xiamen University
    • Principal Investigator: Yanyun Fan
  • Zhenjiang, China, 212000
    • Not yet recruiting
    • Affiliated Hospital of Jiangsu University
    • Principal Investigator: Min Xu
• Germany
  • Berlin, Germany, 10117
    • Not yet recruiting
    • Charité Universitaetsmedizin Berlin - Campus Mitte
    • Principal Investigator: Christoph Jochum
  • Dachau, Germany, 85221
    • Not yet recruiting
    • Studienzentrum MVZ Dachau
    • Principal Investigator: Wilfred Landry
  • Halle, Germany, 06108
    • Not yet recruiting
    • Studiengesellschaft BSF Unternehmergesellschaft
    • Principal Investigator: Lars Fechner
  • Ludwigshafen, Germany, 67067
    • Not yet recruiting
    • St. Marien- und St. Annastiftskrankenhaus
    • Principal Investigator: Tanja Kuehbacher
  • Ulm, Germany, 89081
    • Not yet recruiting
    • Universitaetsklinikum Ulm
    • Principal Investigator: Jochen Klaus
• Hungary
  • Budapest, Hungary, 1082
    • Not yet recruiting
    • Semmelweis Egyetem
    • Principal Investigator: Pal Miheller
  • Budapest, Hungary, 1036
    • Not yet recruiting
    • Óbudai Egészségügyi Centrum
    • Principal Investigator: Tamás Toth
  • Budapest, Hungary, 1066
    • Not yet recruiting
    • Geomedical Egészségügyi Központ
    • Principal Investigator: Gabor Hegede
  • Tatabánya, Hungary, 2800
    • Not yet recruiting
    • Komárom-Esztergom Vármegyei Szent Borbála Kórház
    • Principal Investigator: Samer Francis
• Israel
  • Ashdod, Israel, 7747629
    • Not yet recruiting
    • Assuta Ashdod Medical Center
    • Principal Investigator: Adi Lahat-Zok
  • Haifa, Israel, 3109601
    • Not yet recruiting
    • Rambam Health Care Campus
    • Principal Investigator: Roni Weisshof
  • Jerusalem, Israel, 9103102
    • Not yet recruiting
    • Shaare Zedek Medical Center
    • Principal Investigator: Benjamin Koslowsky
  • Jerusalem, Israel, 9112001
    • Not yet recruiting
    • Hadassah Medical Center
    • Principal Investigator: ADAR ZINGER
  • Petah Tikva, Israel, 4941492
    • Not yet recruiting
    • Rabin Medical Center
    • Principal Investigator: Irit Avni-Biron
  • Ramat Gan, Israel, 5262100
    • Not yet recruiting
    • Sheba Medical Center
    • Principal Investigator: Asaf Levartovsky
  • Ẕerifin, Israel, 7033001
    • Not yet recruiting
    • Yitzhak Shamir Medical Center
    • Principal Investigator: Vered Richter
• Italy
  • Florence, Italy, 50134
    • Not yet recruiting
    • Azienda Ospedaliera Universitaria Careggi
    • Principal Investigator: Gabriele Dragoni
  • Milan, Italy, 20132
    • Not yet recruiting
    • Ospedale San Raffaele
    • Principal Investigator: Silvio Danese
  • Monza, Italy, 20900
    • Not yet recruiting
    • Fondazione IRCCS San Gerardo dei Tintori
    • Principal Investigator: Chiara Viganò
  • Negrar, Italy, 37024
    • Not yet recruiting
    • Ospedale Sacro Cuore Don G. Calabria
    • Principal Investigator: Angela Variola
  • Roma, Italy, 00168
    • Not yet recruiting
    • Fondazione Policlinico Universitario Agostino Gemelli
    • Principal Investigator: Franco Scaldaferri
  • Rozzano, Italy, 20089
    • Not yet recruiting
    • Humanitas
    • Principal Investigator: Alessandro Armuzzi
• Poland
  • Katowice, Poland, 40-600
    • Not yet recruiting
    • Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
    • Principal Investigator: Marek Olakowski
  • Krakow, Poland, 31-228
    • Not yet recruiting
    • Oslomed Centrum Medyczne
    • Principal Investigator: Anna Drozdz
  • Lublin, Poland, 20-582
    • Not yet recruiting
    • Medrise Sp. z o.o.
    • Principal Investigator: Wit Danilkiewicz
  • Poznan, Poland, 60-324
    • Not yet recruiting
    • Twoja Przychodnia PCM
    • Principal Investigator: Ewa Furmanowska-Ladorska
  • Siedlce, Poland, 08-110
    • Not yet recruiting
    • ETG Siedlce
    • Principal Investigator: Anna Lewandowska
  • Szczecin, Poland, 71-434
    • Not yet recruiting
    • Twoja Przychodnia SCM
    • Principal Investigator: Beata Gawdis-Wojnarska
  • Szczecin, Poland, 71-685
    • Not yet recruiting
    • Sonomed Sp. z o. o.
    • Principal Investigator: Anna Wiechowska-Kozlowska
  • Warsaw, Poland, 04-501
    • Not yet recruiting
    • Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
    • Principal Investigator: Jaroslaw Kierkus
  • Warsaw, Poland, 02-786
    • Not yet recruiting
    • WSD Medi
    • Principal Investigator: Michal Krogulecki
  • Zamość, Poland, 22-400
    • Not yet recruiting
    • ETG Zamosc
    • Principal Investigator: Katarzyna Wojcik
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Not yet recruiting
      • Mayo Clinic in Arizona - Scottsdale
      • Principal Investigator: Manreet Kaur
  • California
    • Los Angeles, California, United States, 90035
      • Not yet recruiting
      • Biopharma Informatic, LLC
      • Principal Investigator: Morris Silver, MD
    • Oxnard, California, United States, 93030
      • Not yet recruiting
      • Om Research LLC
      • Principal Investigator: Karen Simon
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Not yet recruiting
      • South Denver Gastroenterology
      • Principal Investigator: Marcelo Kugelmas
  • Florida
    • Miami, Florida, United States, 33176
      • Not yet recruiting
      • Gastro Health Research - Miami
      • Principal Investigator: Lukasz Kwapisz
    • Miami Lakes, Florida, United States, 33015
      • Recruiting
      • Ezy Medical Research
      • Principal Investigator: Hendry Perez-Pascual
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Recruiting
      • Atlanta Gastroenterology Associates - Peachtree Dunwoody
      • Principal Investigator: Nitin Gupta
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Not yet recruiting
      • Rush University Medical Center
      • Principal Investigator: Atsushi Sakuraba
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Recruiting
      • Cotton O'Neil Digestive Health Center
      • Principal Investigator: Curtis Baum
  • Michigan
    • Wyoming, Michigan, United States, 49519
      • Not yet recruiting
      • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
      • Principal Investigator: Allan Coates
  • Missouri
    • St Louis, Missouri, United States, 63123
      • Not yet recruiting
      • KAD Clinical Research
      • Principal Investigator: Adrian Di Bisceglie
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Recruiting
      • Vector Clinical Trials
      • Principal Investigator: Christian Stone
  • North Carolina
    • Wilmington, North Carolina, United States, 28403
      • Not yet recruiting
      • Innovo Research - Wilmington Gastroenterology Associates
      • Principal Investigator: William King
  • Texas
    • Kingwood, Texas, United States, 77339
      • Not yet recruiting
      • One of a Kind Clinical Research Center - Kingwood
      • Principal Investigator: Sushovan Guha
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Southern Star Research Institute
      • Principal Investigator: Jeff Bullock

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mirikizumab; Study Period 1: Mirikizumab administered via IV. Study Period 2: Responders will receive mirikizumab SC.	Drug: Mirikizumab - Intravenous (IV); Administered IV; Other Names: LY3074828; Drug: Mirikizumab - Subcutaneous (SC); Administered SC; Other Names: LY3074828
Experimental: LY4395089 and Mirikizumab Co-Administration; Study Period 1: Co-administration of LY4395089 administered orally and mirikizumab administered IV. Study Period 2: Responders will stop LY4395089 and receive mirikizumab SC.	Drug: Mirikizumab - Intravenous (IV); Administered IV; Other Names: LY3074828; Drug: Mirikizumab - Subcutaneous (SC); Administered SC; Other Names: LY3074828; Drug: LY4395089; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Crohn's Disease who Achieve Endoscopic Response	The percentage of participants who achieve endoscopic response at week 12 of Study Period 1.	Baseline, Up to Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants who Achieve Clinical Remission	Baseline, Up to Week 12
Percent Change from Baseline in Fecal Calprotectin	Baseline, Up to Week 12

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Contact Lilly at 1-877-CTLILLY (1-877-285-4559) or, Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; mirikizumab
• Other Study ID Numbers: 27810; J6Z-MC-CD01 (Other Identifier: Eli Lilly and Company); J6Z-MC-IIBD (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No