Clinical trial 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?
an investigational oral medicine being studied as a potential treatment for Crohn's disease, used together with mirikizumab. is designed to activate the farnesoid X receptor (FXR) in the body.
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 study aims to find out how safe and effective the FXR agonist LY4395089 is when given with mirikizumab, compared to mirikizumab alone, in adults with moderately to severely active Crohn's disease.
- Who it's for
- Adults who have moderately to severely active Crohn's disease.
- What's involved
- Participants will receive either the drug combination (LY4395089 plus mirikizumab) or mirikizumab alone, and will have regular clinic visits and tests to check safety and disease activity.
- Time commitment
- The trial lasts about 62 weeks and includes scheduled visits throughout that period.
- 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 taking glucagon-like peptide-1 (GLP-1) receptor agonists (RAs), GLP-1/glucose-dependent insulinotropic polypeptide (GIP) RAs...
You likely can't join if
- Must not have a hepatic disease
- Must not have a history of any other bone disease that affects bone metabolism
- acute myocardial infarction
- cerebrovascular incident
- hospitalization for unstable angina
- hospitalization due to congestive heart failure, or
See the full eligibility criteria
- 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...
- Must not have a hepatic disease
- Must not have a history of any other bone disease that affects bone metabolism
- 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 is enrolling
- Oxnard, California, United States
- Englewood, Colorado, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Atlanta, Georgia, United States
- Topeka, Kansas, United States
- St Louis, Missouri, United States
- Las Vegas, Nevada, United States
- Kingwood, Texas, United States
- San Antonio, Texas, United States
- Ghent, Belgium
- Leuven, Belgium
- Roeselare, Belgium
- Campinas, Brazil
- Caxias do Sul, Brazil
- Curitiba, Brazil
- Marília, Brazil
- São Paulo, Brazil
- Vitória, Brazil
- Vaughan, Canada
+ 27 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, but 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?
This study is enrolling now at Oxnard, California, United States; Englewood, Colorado, United States; Miami, Florida, United States; Miami Lakes, Florida, United States; Atlanta, Georgia, United States; Topeka, Kansas, United States and 41 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.