Health Trials

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

ConditionCrohn Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • LY4395089

    Drug

    Administered orally

  • Mirikizumab - Intravenous (IV)

    Drug

    Administered IV

  • Mirikizumab - Subcutaneous (SC)

    Drug

    Administered SC

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: MirikizumabActive comparator 2 interventions
Group B: LY4395089 and Mirikizumab Co-AdministrationExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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

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

Time frame
Baseline, Up to Week 12

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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