A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease
Recruiting · NCT07483099 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 11 US states.
- 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
- Assuta Ashdod Medical Center - Ashdod, Israel
- Charité Universitaetsmedizin Berlin - Campus Mitte - Berlin, Germany
- Geomedical Egészségügyi Központ - Budapest, Hungary
- Semmelweis Egyetem - Budapest, Hungary
- Loema Instituto de Pesquisa Clinica - Campinas, Brazil
- Fundação Universidade de Caxias do Sul (FUCS) - Caxias do Sul, Brazil
- The Second Xiangya Hospital of Central South University - Changsha, China
- Changzhou Second People's Hospital - Changzhou, China
- Centro Digestivo de Curitiba - Curitiba, Brazil
- Studienzentrum MVZ Dachau - Dachau, Germany
- Azienda Ospedaliera Universitaria Careggi - Florence, Italy
- AZ Maria Middelares - Ghent, Belgium
- UZ Gent - Ghent, Belgium
- The First Affiliated Hospital, Sun Yat-sen University - Guangzhou, China
- Rambam Health Care Campus - Haifa, Israel
- Studiengesellschaft Mitteldeutschland GmbH - Halle, Germany
- The Second Affiliated hospital of Zhejiang University school of medicine - Hangzhou, China
- Huizhou Central People's Hospital - Huizhou, China
- Shaare Zedek Medical Center - Jerusalem, Israel
- Hadassah Medical Center - Jerusalem, Israel
- Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero - Katowice, Poland
- Centrum Medyczne Oslomed - Krakow, Poland
- Prairie Institute of Liver and Luminal Advanced Research Ltd (PILLAR) - Lethbridge, Canada
- UZ Leuven - Leuven, Belgium
- London Digestive Disease Institute - London, Canada
- Medrise Sp. z o.o. - Lublin, Poland
- St. Marien- und St. Annastiftskrankenhaus - Ludwigshafen, Germany
- Centro de Pesquisa Clínica de Marília - CPCLIM - Marília, Brazil
- Ospedale San Raffaele - Milan, Italy
- Fondazione IRCCS San Gerardo dei Tintori - Monza, Italy
- Ospedale Sacro Cuore Don G. Calabria - Negrar, Italy
- Rabin Medical Center - Petah Tikva, Israel
- Twoja Przychodnia PCM - Poznan, Poland
- Sheba Medical Center - Ramat Gan, Israel
- AZ Delta vzw - Roeselare, Belgium
- Fondazione Policlinico Universitario Agostino Gemelli - Roma, Italy
- Humanitas - Rozzano, Italy
- ETG Siedlce - Siedlce, Poland
- The Second Affiliated Hospital of Soochow University - Suzhou, China
- Twoja Przychodnia SCM - Szczecin, Poland
- Sonomed Sp. z o. o. - Szczecin, Poland
- 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
- Komarom-Esztergom Varmegyei Szent Borbala Korhaz - Tatabánya, Hungary
Showing 60 of 70 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →