RightFit
RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares LY4395089 plus mirikizumab with mirikizumab alone to see how safe they are and how well they work. It is for adults with moderate to severe active Crohn’s disease, which causes swelling in the digestive tract. The study lasts about 62 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Must meet the main IIBD study rules, except those for ulcerative colitis (UC), another bowel disease.
  • If taking GLP-1 medicines or similar medicines for an approved use, must be on a steady dose at screening.

Who can't join

  • Cannot meet any exclusion rules in the main IIBD study plan, except those for ulcerative colitis (UC).
  • Cannot have liver disease.
  • Cannot have a history of another bone disease that affects how bones break down and rebuild.
  • Cannot have had a heart attack or stroke in the 180 days before screening.
  • Cannot have been hospitalized for unstable angina (heart-related chest pain) or heart failure in the 180 days before screening.
  • Cannot have had a procedure to restore blood flow to the heart in the 180 days before screening.
  • Cannot have received, or need, other medicines that the study plan does not allow.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (14)

AZ

CA

CO

FL

GA

  • Atlanta Gastroenterology Associates - Peachtree Dunwoody · Atlanta, GA 30342Nitin Gupta · Principal investigatorMore trials in Atlanta

IL

  • Rush University Medical Center · Chicago, IL 60612Atsushi Sakuraba · Principal investigatorMore trials in Chicago

KS

  • Cotton O'Neil Digestive Health Center · Topeka, KS 66606Curtis Baum · Principal investigatorMore trials in Topeka

MI

  • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center · Wyoming, MI 49519Allan Coates · Principal investigatorMore trials in Wyoming

MO

NV

TX

  • One of a Kind Clinical Research Center - Kingwood · Kingwood, TX 77339Sushovan Guha · Principal investigatorMore trials in Kingwood
  • Southern Star Research Institute · San Antonio, TX 78229Jeff Bullock · Principal investigatorMore trials in San Antonio