A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease (NCT07483099)
A Phase 2, Multicenter, Randomized, Open-Label, Active-Controlled Study to Investigate LY4395089/Mirikizumab Co-administration Compared With Mirikizumab in Adults With Moderately to Severely Active Crohn's Disease
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic in Arizona - Scottsdale — Scottsdale, Arizona
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (70 Sites)
Showing the first 25 of 70 sites.
- Mayo Clinic in Arizona - Scottsdale — Scottsdale, Arizona
- Biopharma Informatic, LLC — Los Angeles, California
- Om Research LLC — Oxnard, California
- South Denver Gastroenterology — Englewood, Colorado
- Gastro Health Research - Miami — Miami, Florida
- Ezy Medical Research — Miami Lakes, Florida
- Atlanta Gastroenterology Associates - Peachtree Dunwoody — Atlanta, Georgia
- Rush University Medical Center — Chicago, Illinois
- Cotton O'Neil Digestive Health Center — Topeka, Kansas
- Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center — Wyoming, Michigan
- KAD Clinical Research — St Louis, Missouri
- Vector Clinical Trials — Las Vegas, Nevada
- One of a Kind Clinical Research Center - Kingwood — Kingwood, Texas
- Southern Star Research Institute — San Antonio, Texas
- AZ Maria Middelares — Ghent,
- UZ Gent — Ghent,
- UZ Leuven — Leuven,
- AZ Delta vzw — Roeselare,
- Loema Instituto de Pesquisa Clinica — Campinas,
- Fundação Universidade de Caxias do Sul (FUCS) — Caxias do Sul,
- Centro Digestivo de Curitiba — Curitiba,
- Centro de Pesquisa Clínica de Marília - CPCLIM — Marília,
- CPHosp Medicina, Ensino e Pesquisa (CPQuali) — São Paulo,
- CPCLIN — São Paulo,
- BR Trials - Ensaios Clinicos e Consultoria — São Paulo,
📞 Contact the Study Coordinator
Phone: (317) 615-4559
Email: clinical_inquiry_hub@lilly.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Crohn Disease
- Safety and Efficacy of EcoActive on Intestinal Adherent Invasive E. Coli in Patients With Inactive Crohn's Disease — Lutherville, Maryland
- Proactive Infliximab Optimization Using a Pharmacokinetic Dashboard Versus Standard of Care in Patients With Inflammatory Bowel Disease: The OPTIMIZE Trial — New Haven, Connecticut
- A Phase 2 Clinical Trial: Xanthohumol Metabolism and Signature (XMaS) in Crohn's Disease — Portland, Oregon
- Resistant Starch in Pediatric Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) — Ottawa, Ontario
- A Long-term Extension Study of Ustekinumab in Pediatric Participants — Atlanta, Georgia
- Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease — Atlanta, Georgia
Explore by condition: All Crohn Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.