In short
LY4395089 is an investigational drug being studied in adults with moderately to severely active Crohn's disease. It is being tested in one Phase 2 clinical trial that plans to enroll 70 participants. The study compares LY4395089 given together with mirikizumab against mirikizumab alone.
Key points
- LY4395089 is an investigational drug with no marketing authorisation in these records.
- It is being studied in a Phase 2 trial in adults with Crohn's disease.
- The trial plans to enroll 70 participants.
- The study compares LY4395089 plus mirikizumab against mirikizumab alone.
- The main measure is endoscopic response after 12 weeks of treatment.
- The trial is currently authorised and recruiting.
What is LY4395089?
LY4395089 is an investigational drug being developed by Eli Lilly and Company. It is being studied in a Phase 2 clinical trial in adults with moderately to severely active Crohn's disease. The trial record in the EU Clinical Trials Information System (CTIS) lists LY4395089 as a test drug, meaning it is the substance under investigation. No marketing authorisation for LY4395089 is recorded in these sources, so it is not yet an approved medicine.
How does LY4395089 work?
The available sources do not describe the mechanism of action of LY4395089. The trial investigates LY4395089 given together with mirikizumab, an antibody that blocks a protein involved in inflammation. The study is designed to see whether adding LY4395089 to mirikizumab improves endoscopic outcomes compared with mirikizumab alone.
Which conditions is LY4395089 being studied for?
- Crohn's disease — a long-term inflammatory bowel disease that causes inflammation anywhere in the digestive tract, leading to pain, diarrhoea and fatigue. The trial focuses on adults with moderately to severely active Crohn's disease.
- Ulcerative colitis — a related inflammatory bowel disease affecting the large intestine. The master protocol also covers ulcerative colitis, although the LY4395089 sub-study is in Crohn's disease.
How is LY4395089 given?
LY4395089 is given by oral use, meaning it is taken by mouth. The trial record does not report a dose for LY4395089, so the dose is not stated in the register. Mirikizumab, the comparison drug, is given either by subcutaneous use at 300 mg or by intravenous use at 900 mg.
What do the clinical trials show?
There is one Phase 2 clinical trial of LY4395089, recorded under the EU CT number 2025-524112-11-00. The trial is authorised and recruiting, with a planned enrollment of 70 participants. It is a multicentre, randomised, open-label, active-controlled study. Participants are adults with moderately to severely active Crohn's disease.
The main measure is endoscopic response: whether the inflammation seen during an endoscopy improves after 12 weeks of treatment. Endoscopic response means that the appearance of the bowel lining improves when viewed with a camera. The study compares LY4395089 given together with mirikizumab against mirikizumab alone.
What side effects are known?
The available sources do not report side effects for LY4395089. No safety data specific to LY4395089 are provided in the trial record or the supplementary source.