NCT06937099 · Eli Lilly and Company
Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
(COMMIT-CD)
What this study is about
The main purpose of this study is to evaluate the effectiveness 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.
View original scientific description
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.
Interventions
DRUG
Mirikizumab
Administered IV
DRUG
Mirikizumab
Administered SC
DRUG
Tirzepatide
Administered SC
DRUG
Placebo
Administered SC
Primary outcome measures
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
Percentage of participants who simultaneously achieve clinical remission by CDAI, endoscopic remission and at least 10% weight reduction.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Dothan, Alabama
- Anaheim, California
- Beverly Hills, California
- Los Alamitos, California
- Northridge, California
- Miami, Florida
- Orlando, Florida
- Pensacola, Florida
- Sunrise, Florida
- Idaho Falls, Idaho
- Chicago, Illinois
- Indianapolis, Indiana
And 20 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 7, 2026 · Source of record for eligibility and locations