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Clinical Trials in China / NCT07483099
Recruiting Phase 2

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

NCT07483099 · tracked via the Priya Life Science China tracker
Sponsor
Eli Lilly and Company
Phase
Phase 2
Started
2026-05-04
Last updated
2026-09-08

Condition(s) studied

Crohn Disease

Investigational drug(s) / intervention(s)

LY4395089Mirikizumab - Intravenous (IV)Mirikizumab - Subcutaneous (SC)

LY4395089: Administered orally

Mirikizumab - Intravenous (IV): Administered IV

Mirikizumab - Subcutaneous (SC): Administered SC

Study summary

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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (70)

FacilityCityRegionStatus
Mayo Clinic in Arizona - Scottsdale Scottsdale Arizona Suspended
Biopharma Informatic, LLC Los Angeles California Not Yet Recruiting
Om Research LLC Oxnard California Recruiting
South Denver Gastroenterology Englewood Colorado Recruiting
Gastro Health Research - Miami Miami Florida Recruiting
Ezy Medical Research Miami Lakes Florida Recruiting
Atlanta Gastroenterology Associates - Peachtree Dunwoody Atlanta Georgia Recruiting
Rush University Medical Center Chicago Illinois Not Yet Recruiting
Cotton O'Neil Digestive Health Center Topeka Kansas Recruiting
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center Wyoming Michigan Not Yet Recruiting
KAD Clinical Research St Louis Missouri Recruiting
Vector Clinical Trials Las Vegas Nevada Recruiting
One of a Kind Clinical Research Center - Kingwood Kingwood Texas Not Yet Recruiting
Southern Star Research Institute San Antonio Texas Recruiting
AZ Maria Middelares Ghent Belgium Not Yet Recruiting
UZ Gent Ghent Belgium Not Yet Recruiting
UZ Leuven Leuven Belgium Not Yet Recruiting
AZ Delta vzw Roeselare Belgium Not Yet Recruiting
Loema Instituto de Pesquisa Clinica Campinas Brazil Not Yet Recruiting
Fundação Universidade de Caxias do Sul (FUCS) Caxias do Sul Brazil Not Yet Recruiting
Centro Digestivo de Curitiba Curitiba Brazil Not Yet Recruiting
Centro de Pesquisa Clínica de Marília - CPCLIM Marília Brazil Not Yet Recruiting
CPHosp Medicina, Ensino e Pesquisa (CPQuali) São Paulo Brazil Not Yet Recruiting
CPCLIN São Paulo Brazil Not Yet Recruiting
BR Trials - Ensaios Clinicos e Consultoria São Paulo Brazil Not Yet Recruiting
Clínica Hepatogastro JK São Paulo Brazil Not Yet Recruiting
CEDOES Vitória Brazil Not Yet Recruiting
Prairie Institute of Liver and Luminal Advanced Research Ltd (PILLAR) Lethbridge Canada Not Yet Recruiting
London Digestive Disease Institute London Canada Suspended
Tdda Inc. Vaughan Canada Recruiting
The Second Xiangya Hospital of Central South University Changsha China Recruiting
Changzhou Second People's Hospital Changzhou China Recruiting
The First Affiliated Hospital, Sun Yat-sen University Guangzhou China Recruiting
The Second Affiliated hospital of Zhejiang University school of medicine Hangzhou China Recruiting
Huizhou Central People's Hospital Huizhou China Recruiting
The Second Affiliated Hospital of Soochow University Suzhou China Recruiting
The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university Wenzhou China Recruiting
Zhongshan Hospital Affiliated to Xiamen University Xiamen China Recruiting
Affiliated Hospital of Jiangsu University Zhenjiang China Recruiting
Charité Universitaetsmedizin Berlin - Campus Mitte Berlin Germany Not Yet Recruiting

+ 30 more sites — see the full list on the official registry below.

More Eli Lilly and Company trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07483099 on ClinicalTrials.gov ↗ ← All trials in China