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

Purpose

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.

Condition

  • Crohn Disease

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Mirikizumab 		Study Period 1: Mirikizumab administered via IV. Study Period 2: Responders will receive mirikizumab SC.
  • Drug: LY4395089
    Administered orally
  • Drug: Mirikizumab - Intravenous (IV)
    Administered IV
    Other names:
    • LY3074828
  • Drug: Mirikizumab - Subcutaneous (SC)
    Administered SC
    Other names:
    • LY3074828
Experimental
LY4395089 and Mirikizumab Co-Administration 		Study Period 1: Co-administration of LY4395089 administered orally and mirikizumab administered IV. Study Period 2: Responders will stop LY4395089 and receive mirikizumab SC.
  • Drug: LY4395089
    Administered orally
  • Drug: Mirikizumab - Intravenous (IV)
    Administered IV
    Other names:
    • LY3074828
  • Drug: Mirikizumab - Subcutaneous (SC)
    Administered SC
    Other names:
    • LY3074828

Recruiting Locations

Ezy Medical Research
Miami Lakes, Florida 33015

Atlanta Gastroenterology Associates - Peachtree Dunwoody
Atlanta, Georgia 30342

Cotton O'Neil Digestive Health Center
Topeka, Kansas 66606

Vector Clinical Trials
Las Vegas, Nevada 89128

Southern Star Research Institute
San Antonio, Texas 78229

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

There may be multiple sites in this clinical trial. (Add "This 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
clinical_inquiry_hub@lilly.com