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

NCT07483099

RecruitingPhase 2

Sponsor: Eli Lilly and Company

Conditions: Crohn Disease

Interventions: LY4395089, Mirikizumab - Intravenous (IV), Mirikizumab - Subcutaneous (SC)

Countries: United States, Belgium, Brazil, Canada, China, Germany, Hungary, Israel

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 overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (70)
  • Scottsdale, Arizona, United States
  • Los Angeles, California, United States
  • Oxnard, California, United States
  • Englewood, Colorado, United States
  • Miami, Florida, United States
  • Miami Lakes, Florida, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Topeka, Kansas, United States
  • Wyoming, Michigan, United States
  • St Louis, Missouri, United States
  • Las Vegas, Nevada, United States
  • Kingwood, Texas, United States
  • San Antonio, Texas, United States
  • Ghent, Belgium
  • Ghent, Belgium
  • Leuven, Belgium
  • Roeselare, Belgium
  • Campinas, Brazil
  • Caxias do Sul, Brazil
  • Curitiba, Brazil
  • Marília, Brazil
  • São Paulo, Brazil
  • São Paulo, Brazil
  • São Paulo, Brazil
  • São Paulo, Brazil
  • Vitória, Brazil
  • Lethbridge, Canada
  • London, Canada
  • Vaughan, Canada
  • + 40 more on CT.gov