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Mirikizumab and Tirzepatide for Crohn's Disease and Obesity/Overweight

This study is looking for adults aged 18 to 70 with moderately to severely active Crohn's disease and who are also obese or overweight. We are testing two medicines: mirikizumab and tirzepatide. Mirikizumab is given either into a vein (IV) or under the skin (SC), and tirzepatide is given under the skin. Some participants will receive a placebo (an inactive substance). The main goal is to see how well these medicines work together to help with Crohn's disease symptoms and lead to at least 10% weight loss after 52 weeks. The study is currently recruiting about 290 participants.

Study design
This interventional study will compare mirikizumab alone to mirikizumab given with tirzepatide, or mirikizumab with a placebo. It plans to enroll 290 participants.
What's involved
The maximum duration of this study is up to 61 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured at Week 52, suggesting follow-up for at least this long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06937099

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

Recruiting
PHASE3Ages 18–70InterventionalTreatment
Eli Lilly and Company
~290 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:MirikizumabTirzepatidePlacebo

At a glance

Recruiting sites
170 of 184 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants Who Simultaneously Achieve Clinical Remission by Crohn's Disease Activity Index (CDAI), Endoscopic Remission, and at least 10% Weight Reduction
Measured over Week 52

Conditions

Crohn's Disease
Obesity or Overweight

Explore related trials

Crohn DiseaseObesityOverweight

Where it's being run

184 sites across 43 states
Mexico16
Brazil15
Poland12
France11
Spain10
Italy9
Turkey (Türkiye)9
Israel8

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Have a confirmed diagnosis of Crohn's disease (CD) or perianal fistulizing CD
Have obesity body mass index 30 kilograms per meter squared (BMI ≥30 kg/m²), or overweight (BMI ≥27 kg/m2 to \<30 kg/m²) and in the presence of at least 1 weight-related comorbid conditions:
hypertension
Type 2 diabetes mellitus (T2DM)
dyslipidemia
obstructive sleep apnea, or
cardiovascular disease.
Have moderately to severely active CD defined by a CDAI score of at least 220 at baseline.
Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for patients with ileal-colonic or ≥4 for patients with isolated ileal disease within 21 days before the first dose of study treatment.
Participants with a history of CD for ≥8 years involving only or predominantly the colon must have documented negative results for colorectal dysplasia and cancer within 1 year prior to baseline.
Demonstrated inadequate response, loss of response or intolerance to at least one protocol-specified conventional or advanced CD therapy

Exclusion

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.
Have a history of more than 3 small bowel resections, total resection of small bowel greater than 100 centimeters (cm), diagnosis of short bowel syndrome, or any intestinal or non-intestinal intra-abdominal surgery within 3 months of baseline.
Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) or have insulin-treated T2DM.
Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening.
Have had more than 5% body weight change in the past 3 months
Have a current or recent acute, active infection.

What this trial measures

  • Percentage of Participants Who Simultaneously Achieve Clinical Remission by Crohn's Disease Activity Index (CDAI), Endoscopic Remission, and at least 10% Weight ReductionWeek 52

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