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

Recruiting now · Phase 2

Conditions studied: Crohn Disease

In brief

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.

Key facts

Study ID

NCT07483099

Run by

Eli Lilly and Company

People needed

60

Starts

2026-05-04

Expected to finish

2028-03-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Shaare Zedek Medical Center — Jerusalem, Israel (enrolling)
• Yitzhak Shamir Medical Center — Ẕerifin, Israel (enrolling)
• Huizhou Central People's Hospital — Huizhou, China (enrolling)
• Rambam Health Care Campus — Haifa, Israel (enrolling)
• Rabin Medical Center — Petah Tikva, Israel (enrolling)
• Sheba Medical Center — Ramat Gan, Israel (enrolling)
• The Second Xiangya Hospital of Central South University — Changsha, China (enrolling)
• The Second Affiliated hospital of Zhejiang University school of medicine — Hangzhou, China (enrolling)
• The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university — Wenzhou, China (enrolling)
• Affiliated Hospital of Jiangsu University — Zhenjiang, China (enrolling)
• Hadassah Medical Center — Jerusalem, Israel (enrolling)
• Ezy Medical Research — Miami Lakes, Florida, United States (enrolling)
• Southern Star Research Institute — San Antonio, Texas, United States (enrolling)
• Atlanta Gastroenterology Associates - Peachtree Dunwoody — Atlanta, Georgia, United States (enrolling)
• South Denver Gastroenterology — Englewood, Colorado, United States (enrolling)
• Tdda Inc. — Vaughan, Canada (enrolling)
• Cotton O'Neil Digestive Health Center — Topeka, Kansas, United States (enrolling)
• Changzhou Second People's Hospital — Changzhou, China (enrolling)
• Gastro Health Research - Miami — Miami, Florida, United States (enrolling)
• The Second Affiliated Hospital of Soochow University — Suzhou, China (enrolling)
• KAD Clinical Research — St Louis, Missouri, United States (enrolling)
• Zhongshan Hospital Affiliated to Xiamen University — Xiamen, China (enrolling)
• Vector Clinical Trials — Las Vegas, Nevada, United States (enrolling)
• Om Research LLC — Oxnard, California, United States (enrolling)
• AZ Maria Middelares — Ghent, Belgium

Full record on ClinicalTrials.gov

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