RecruitingRecruiting
A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease
NCT07483099 · Eli Lilly and Company
In plain English
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Official title
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
About this study
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
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 design
Enrollment target: 60 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-05-04
Estimated completion: 2028-03
Last updated: 2026-06-04
Interventions
Drug: LY4395089Drug: Mirikizumab - Intravenous (IV)Drug: Mirikizumab - Subcutaneous (SC)
Primary outcomes
- • Percentage of Participants with Crohn's Disease who Achieve Endoscopic Response (Baseline, Up to Week 12)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactThere may be multiple sites in this clinical trial. (Add "This 1-877-CTLILLY (1-877-285-4559) or · contact · clinical_inquiry_hub@lilly.com · 1-317-615-4559
InvestigatorContact Lilly at 1-877-CTLILLY (1-877-285-4559) or · study_director, Eli Lilly and Company
All locations (72)
Mayo Clinic in Arizona - ScottsdaleNot Yet Recruiting
Scottsdale, Arizona, United States
Biopharma Informatic, LLCNot Yet Recruiting
Los Angeles, California, United States
Om Research LLCNot Yet Recruiting
Oxnard, California, United States
South Denver GastroenterologyNot Yet Recruiting
Englewood, Colorado, United States
Gastro Health Research - MiamiNot Yet Recruiting
Miami, Florida, United States
Ezy Medical ResearchRecruiting
Miami Lakes, Florida, United States
Atlanta Gastroenterology Associates - Peachtree DunwoodyRecruiting
Atlanta, Georgia, United States
Rush University Medical CenterNot Yet Recruiting
Chicago, Illinois, United States
Cotton O'Neil Digestive Health CenterRecruiting
Topeka, Kansas, United States
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research CenterNot Yet Recruiting
Wyoming, Michigan, United States
KAD Clinical ResearchNot Yet Recruiting
St Louis, Missouri, United States
Vector Clinical TrialsRecruiting
Las Vegas, Nevada, United States
Innovo Research - Wilmington Gastroenterology AssociatesNot Yet Recruiting
Wilmington, North Carolina, United States
One of a Kind Clinical Research Center - KingwoodNot Yet Recruiting
Kingwood, Texas, United States
Southern Star Research InstituteRecruiting
San Antonio, Texas, United States
AZ Maria MiddelaresNot Yet Recruiting
Ghent, Belgium
UZ GentNot Yet Recruiting
Ghent, Belgium
UZ LeuvenNot Yet Recruiting
Leuven, Belgium
AZ Delta vzwNot Yet Recruiting
Roeselare, Belgium
Loema Instituto de Pesquisa ClinicaNot Yet Recruiting
Campinas, Brazil
Fundação Universidade de Caxias do Sul (FUCS)Not Yet Recruiting
Caxias do Sul, Brazil
Centro Digestivo de CuritibaNot Yet Recruiting
Curitiba, Brazil
Centro de Pesquisa Clínica de Marília - CPCLIMNot Yet Recruiting
Marília, Brazil
CPHosp Medicina, Ensino e Pesquisa (CPQuali)Not Yet Recruiting
São Paulo, Brazil
CPCLINNot Yet Recruiting
São Paulo, Brazil
BR Trials - Ensaios Clinicos e ConsultoriaNot Yet Recruiting
São Paulo, Brazil
Solare TrialsNot Yet Recruiting
São Paulo, Brazil
Clínica Hepatogastro JKNot Yet Recruiting
São Paulo, Brazil
CEDOESNot Yet Recruiting
Vitória, Brazil
Prairie Institute of Liver and Luminal Advanced Research Ltd (PILLAR)Not Yet Recruiting
Lethbridge, Canada
London Digestive Disease InstituteNot Yet Recruiting
London, Canada
Tdda Inc.Not Yet Recruiting
Vaughan, Canada
The Second Xiangya Hospital of Central South UniversityNot Yet Recruiting
Changsha, China
Changzhou Second People's HospitalNot Yet Recruiting
Changzhou, China
The First Affiliated Hospital, Sun Yat-sen UniversityNot Yet Recruiting
Guangzhou, China
The Second Affiliated hospital of Zhejiang University school of medicineNot Yet Recruiting
Hangzhou, China
Huizhou Central People's HospitalNot Yet Recruiting
Huizhou, China
The Second Affiliated Hospital of Soochow UniversityNot Yet Recruiting
Suzhou, China
The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical universityNot Yet Recruiting
Wenzhou, China
Zhongshan Hospital Affiliated to Xiamen UniversityNot Yet Recruiting
Xiamen, China
Affiliated Hospital of Jiangsu UniversityNot Yet Recruiting
Zhenjiang, China
Charité Universitaetsmedizin Berlin - Campus MitteNot Yet Recruiting
Berlin, Germany
Studienzentrum MVZ DachauNot Yet Recruiting
Dachau, Germany
Studiengesellschaft BSF UnternehmergesellschaftNot Yet Recruiting
Halle, Germany
St. Marien- und St. AnnastiftskrankenhausNot Yet Recruiting
Ludwigshafen, Germany
Universitaetsklinikum UlmNot Yet Recruiting
Ulm, Germany
Geomedical Egészségügyi KözpontNot Yet Recruiting
Budapest, Hungary
Semmelweis EgyetemNot Yet Recruiting
Budapest, Hungary
Komarom-Esztergom Varmegyei Szent Borbala KorhazNot Yet Recruiting
Tatabánya, Hungary
Assuta Ashdod Medical CenterNot Yet Recruiting
Ashdod, Israel
Rambam Health Care CampusNot Yet Recruiting
Haifa, Israel
Shaare Zedek Medical CenterNot Yet Recruiting
Jerusalem, Israel
Hadassah Medical CenterNot Yet Recruiting
Jerusalem, Israel
Rabin Medical CenterNot Yet Recruiting
Petah Tikva, Israel
Sheba Medical CenterNot Yet Recruiting
Ramat Gan, Israel
Yitzhak Shamir Medical CenterNot Yet Recruiting
Ẕerifin, Israel
Azienda Ospedaliera Universitaria CareggiNot Yet Recruiting
Florence, Italy
Ospedale San RaffaeleNot Yet Recruiting
Milan, Italy
Fondazione IRCCS San Gerardo dei TintoriNot Yet Recruiting
Monza, Italy
Ospedale Sacro Cuore Don G. CalabriaNot Yet Recruiting
Negrar, Italy
Fondazione Policlinico Universitario Agostino GemelliNot Yet Recruiting
Roma, Italy
HumanitasNot Yet Recruiting
Rozzano, Italy
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział LiberoNot Yet Recruiting
Katowice, Poland
Oslomed Centrum MedyczneNot Yet Recruiting
Krakow, Poland
Medrise Sp. z o.o.Not Yet Recruiting
Lublin, Poland
Twoja Przychodnia PCMNot Yet Recruiting
Poznan, Poland
ETG SiedlceNot Yet Recruiting
Siedlce, Poland
Twoja Przychodnia SCMNot Yet Recruiting
Szczecin, Poland
Sonomed Sp. z o. o.Not Yet Recruiting
Szczecin, Poland
WSD MEDINot Yet Recruiting
Warsaw, Poland
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor KierkuśNot Yet Recruiting
Warsaw, Poland
ETG ZamośćNot Yet Recruiting
Zamość, Poland