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New treatment option for Crohn Disease
Official title A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease
ClinicalTrials.gov ID: NCT07483099
What this study is testing
What is LY4395089?
LY4395089 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for crohn disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Participants must meet all the 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...
You likely can't join 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...
- 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
See the full eligibility criteria
- Participants must meet all the 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- 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
- Wilmington, North Carolina, United States
- Kingwood, Texas, United States
- San Antonio, Texas, United States
- Ghent, Belgium
- Leuven, Belgium
- Roeselare, Belgium
- Campinas, Brazil
- Caxias do Sul, Brazil
+ 43 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 and 57 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.