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Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn’s Disease and Obesity or Overweight: Phase 3b Study (COMMIT-CD)
EU CTIS ID: 2024-520210-21-00
What this study is testing
To evaluate if concomitant administration of mirikizumab and tirzepatide at the MTD (up to 15 mg) is superior to mirikizumab and placebo in simultaneously achieving clinical remission, endoscopic remission, and weight reduction.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Have had a diagnosis of Crohn’s disease (CD) or perianal fistulizing CD established at least 3 months prior to enrollment with tests confirming the diagnosis.
- Have moderately to severely active CD defined by a CDAI score of at least 220 at baseline.
- SES-CD score of at least 6 or 4 (isolated ileal)
- Participants with a history of CD involving only or predominantly the colon for greater than or equal to 8 years with a surveillance colonoscopy within 1 year prior to baseline must have documented negative results for colorectal dysplasia and cancer.
- Be obese with a body mass index (BMI) of 30 or higher or be overweight with a BMI between 27 and 30 and have at least one of the following conditions related to weight: high blood pressure, type 2 diabetes, abnormal cholesterol levels, sleep apnea (a condition where you stop breathing for short periods during sleep), or heart disease.
- Have tried and not responded well to at least one conventional CD medication (like oral such as corticosteroids or azathioprine) and also not respond well to advanced CD therapies (like biologics or JAK inhibitors).
You likely can't join if
- 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.
- 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 Type 1 diabetes or Type 2 diabetes treated with insulin.
- Have had severe low blood sugar or unawareness of low blood sugar in the past 6 months.
See the full eligibility criteria
- Have had a diagnosis of Crohn’s disease (CD) or perianal fistulizing CD established at least 3 months prior to enrollment with tests confirming the diagnosis.
- Have moderately to severely active CD defined by a CDAI score of at least 220 at baseline.
- SES-CD score of at least 6 or 4 (isolated ileal)
- Participants with a history of CD involving only or predominantly the colon for greater than or equal to 8 years with a surveillance colonoscopy within 1 year prior to baseline must have documented negative results for colorectal dysplasia and cancer.
- Be obese with a body mass index (BMI) of 30 or higher or be overweight with a BMI between 27 and 30 and have at least one of the following conditions related to weight: high blood pressure, type 2 diabetes, abnormal cholesterol levels, sleep apnea (a condition where you stop breathing for short periods during sleep), or heart disease.
- Have tried and not responded well to at least one conventional CD medication (like oral such as corticosteroids or azathioprine) and also not respond well to advanced CD therapies (like biologics or JAK inhibitors).
- 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.
- 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 Type 1 diabetes or Type 2 diabetes treated with insulin.
- Have had severe low blood sugar or unawareness of low blood sugar in the past 6 months.
- Have had more than 5% body weight change in the past 3 months.
- Have a current or recent serious infection.
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- Israel
- Canada
- Mexico
- United States
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey; Israel; Canada; Mexico; United States; Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.