COMMIT-CD

RecruitingPhase 3

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

A Phase 3b, Randomized, Multicenter, Controlled Study of Mirikizumab and Placebo or Mirikizumab Concomitantly Administered With Tirzepatide in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight

Lead sponsor

Eli Lilly and Company

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

187

Recruiting sites

158

Enrollment

290

estimated

Study population

Gastrointestinal (gastroparesis / short bowel / pancreatitis), Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoint

•Percentage of Participants Who Simultaneously Achieve Clinical Remission (clinical remission cdai, endoscopic remission, ≥10% weight-loss responders)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06937099

Org study ID27281

Secondary ID2024-520210-21-00

Secondary IDI6T-MC-AMCEEli Lilly and Company

Timeline

Milestones

Study first posted2025-04-22actual

Study start2025-06-26actual

Last update posted2026-05-20actual

Primary completion2028-05estimated (month precision)

Study completion2028-05estimated (month precision)

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Gastrointestinal (gastroparesis / short bowel / pancreatitis)Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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 criteria

•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.

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Weight & body composition

Patient-reported / QoL

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Percentage of Participants Who Achieve at Least a 10% Reduction in Body Weight

Time frame:Week 52

≥10% weight-loss responders

threshold achievement, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)

Time frame:Baseline, Week 52

change from baseline, improvement

Other clinical outcomes

5 endpoints

Primary/protocol endpoint/low confidence

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

Time frame:Week 52

threshold achievement, improvement

componentsclinical remission cdai, endoscopic remission, ≥10% weight-loss responders

Secondary/protocol endpoint

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

Time frame:Week 24, 52

threshold achievement, improvement

componentsclinical remission cdai, endoscopic remission

Secondary/protocol endpoint

Percentage of Participants Who Achieved Maintenance of Clinical Remission by CDAI

Time frame:Week 52

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieved Maintenance of Endoscopic Remission

Time frame:Week 52

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Week 52

threshold achievement, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.