Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07483099

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

AZ Maria Middelares, Ghent, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY4395089

Drug

Administered orally

Mirikizumab - Intravenous (IV)

Drug

Administered IV

Other names: LY3074828

Mirikizumab - Subcutaneous (SC)

Drug

Administered SC

Other names: LY3074828

Primary outcomes

  1. Percentage of Participants with Crohn's Disease who Achieve Endoscopic Response

    Time frame: Baseline, Up to Week 12

    The percentage of participants who achieve endoscopic response at week 12 of Study Period 1.

Secondary outcomes

  1. Percentage of Participants who Achieve Clinical Remission

    Time frame: Baseline, Up to Week 12

  2. Percent Change from Baseline in Fecal Calprotectin

    Time frame: Baseline, Up to Week 12

Study contacts

Contact information is provided by the study sponsor or research team.

There may be multiple sites in this clinical trial. (Add "This 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 19, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.