NCT07483099RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 16 Mar 2026
- Start date
- 4 May 2026
- Primary completion date
- Jun 2027
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Crohn's disease
- NCT number
- NCT07483099
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 4 May 2026 to the primary completion date, Jun 2027
- 71 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Must not have a hepatic disease
- Must not have a history of any other bone disease that affects bone metabolism
Other
- 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:
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (71)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AZ Maria Middelares Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
| UZ Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Not yet recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| AZ Delta vzw Coordinator of this site? Confirm its status | Roeselare | Belgium | Recruiting |
| Loema Instituto de Pesquisa Clinica Coordinator of this site? Confirm its status | Campinas | Brazil | Recruiting |
| Fundação Universidade de Caxias do Sul (FUCS) Coordinator of this site? Confirm its status | Caxias do Sul | Brazil | Recruiting |
| Centro Digestivo de Curitiba Coordinator of this site? Confirm its status | Curitiba | Brazil | Recruiting |
| Centro de Pesquisa Clínica de Marília - CPCLIM Coordinator of this site? Confirm its status | Marília | Brazil | Recruiting |
| Clínica Hepatogastro JK Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| BR Trials-Ensaios Clinicos e Consultoria Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| CPHosp Medicina, Ensino e Pesquisa (CPQuali) Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| CPCLIN Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| CEDOES Coordinator of this site? Confirm its status | Vitória | Brazil | Recruiting |
| Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre Coordinator of this site? Confirm its status | Greenfield Park | Canada | Not yet recruiting |
| Prairie Institute of Liver and Luminal Advanced Research Ltd (PILLAR) Coordinator of this site? Confirm its status | Lethbridge | Canada | Not yet recruiting |
| London Digestive Disease Institute Coordinator of this site? Confirm its status | London | Canada | Not yet recruiting |
| Tdda Inc. Coordinator of this site? Confirm its status | Vaughan | Canada | Recruiting |
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| Changzhou Second People's Hospital Coordinator of this site? Confirm its status | Changzhou | China | Recruiting |
| The First Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The Second Affiliated Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Huizhou Central People's Hospital Coordinator of this site? Confirm its status | Huizhou | China | Recruiting |
| The Second Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university Coordinator of this site? Confirm its status | Wenzhou | China | Recruiting |
| Zhongshan Hospital Affiliated to Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Recruiting |
| Affiliated Hospital of Jiangsu University Coordinator of this site? Confirm its status | Zhenjiang | China | Recruiting |
| Charité Universitaetsmedizin Berlin - Campus Mitte Coordinator of this site? Confirm its status | Berlin | Germany | Not yet recruiting |
| Studienzentrum MVZ Dachau Coordinator of this site? Confirm its status | Dachau | Germany | Suspended |
| Studiengesellschaft Mitteldeutschland GmbH Coordinator of this site? Confirm its status | Halle | Germany | Recruiting |
| St. Marien- und St. Annastiftskrankenhaus Coordinator of this site? Confirm its status | Ludwigshafen | Germany | Recruiting |
| Universitaetsklinikum Ulm Coordinator of this site? Confirm its status | Ulm | Germany | Not yet recruiting |
| Semmelweis Egyetem Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Geomedical Egészségügyi Központ Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Komarom-Esztergom Varmegyei Szent Borbala Korhaz Coordinator of this site? Confirm its status | Tatabánya | Hungary | Recruiting |
| Assuta Ashdod Medical Center Coordinator of this site? Confirm its status | Ashdod | Israel | Recruiting |
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Rabin Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Yitzhak Shamir Medical Center Coordinator of this site? Confirm its status | Tsrifin | Israel | Recruiting |
| Azienda Ospedaliera Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Not yet recruiting |
| Ospedale Sacro Cuore Don G. Calabria Coordinator of this site? Confirm its status | Negrar | Italy | Not yet recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli Coordinator of this site? Confirm its status | Roma | Italy | Not yet recruiting |
| Humanitas Coordinator of this site? Confirm its status | Rozzano | Italy | Not yet recruiting |
| Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Centrum Medyczne Oslomed Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
| Medrise Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Not yet recruiting |
| Twoja Przychodnia PCM Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| ETG Siedlce Coordinator of this site? Confirm its status | Siedlce | Poland | Recruiting |
| Sonomed Sp. z o.o. Coordinator of this site? Confirm its status | Szczecin | Poland | Recruiting |
| Twoja Przychodnia SCM Coordinator of this site? Confirm its status | Szczecin | Poland | Recruiting |
| WSD MEDI Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
| Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| ETG Zamosc Coordinator of this site? Confirm its status | Zamość | Poland | Recruiting |
| Atlanta Gastroenterology Associates - Peachtree Dunwoody Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Rush University Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Not yet recruiting |
| South Denver Gastroenterology Coordinator of this site? Confirm its status | Englewood | United States | Recruiting |
| One of a Kind Clinical Research Center - Kingwood Coordinator of this site? Confirm its status | Kingwood | United States | Recruiting |
| Vector Clinical Trials Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Biopharma Informatic LLC Coordinator of this site? Confirm its status | Los Angeles | United States | Not yet recruiting |
| Gastro Health Research - Miami Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Ezy Medical Research Coordinator of this site? Confirm its status | Miami Lakes | United States | Recruiting |
| OM Research LLC Coordinator of this site? Confirm its status | Oxnard | United States | Recruiting |
| Southern Star Research Institute Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Mayo Clinic in Arizona - Scottsdale Coordinator of this site? Confirm its status | Scottsdale | United States | Suspended |
| KAD Clinical Research Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Cotton O'Neil Digestive Health Center Coordinator of this site? Confirm its status | Topeka | United States | Recruiting |
| Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center Coordinator of this site? Confirm its status | Wyoming | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.