Health Trials

Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight

ConditionsCrohn's DiseaseObesity or Overweight
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorEli Lilly and Company

About this trial

The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight.

The maximum duration of this study is up to 61 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have a confirmed diagnosis of Crohn's disease (CD) or perianal fistulizing CD

hypertension

Type 2 diabetes mellitus (T2DM)

dyslipidemia

Disqualifiers

Have a current diagnosis of Ulcerative Colitis (UC), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis.

Have more than 2 missing segments of the following 5 segments: terminal ileum, ·right colon, transverse colon, ·left colon, and rectum.

Currently have or are suspected to have an abscess.

Have a stoma, ileoanal pouch, or ostomy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mirikizumab

    Drug

    Administered IV

  • Mirikizumab

    Drug

    Administered SC

  • Tirzepatide

    Drug

    Administered SC

  • Placebo

    Drug

    Administered SC

Treatment groups

290 Participants
are divided into 2 treatment groups
Group A: Mirikizumab + TirzepatideExperimental treatment 2 interventions
Group B: Mirikizumab + PlaceboExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Percentage of Participants Who Simultaneously Achieve Clinical Remission by Crohn's Disease Activity Index (CDAI), Endoscopic Remission, and at least 10% Weight Reduction

Percentage of participants who simultaneously achieve clinical remission by CDAI, endoscopic remission and at least 10% weight reduction.

Time frame
Week 52

Secondary outcomes

1

Percentage of Participants Who Simultaneously Achieve Clinical Remission by CDAI and Endoscopic Remission

Percentage of participants who simultaneously achieve clinical remission by CDAI and endoscopic remission.

Time frame
Week 24, 52
2

Percentage of Participants Who Achieved Maintenance of Clinical Remission by CDAI

Percentage of participants who achieve maintenance of clinical remission by CDAI.

Time frame
Week 52
3

Percentage of Participants Who Achieved Maintenance of Endoscopic Remission

Percentage of participants who achieve maintenance of endoscopic remission.

Time frame
Week 52
4

Percentage of Participants Who Achieve Corticosteroid-free Clinical Remission by CDAI Among Participants Who Used Corticosteroids at Baseline

Percentage of participants who achieve corticosteroid-free clinical remission by CDAI among participants who used corticosteroids at baseline.

Time frame
Week 52

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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