Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
Recruiting · 40 sites across 22 states
Always free
Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
Ask for your language
Your choice
Voluntary — you can stop anytime
What is this study?
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.
It is , overseen by an independent and licensed medical staff.
Read the full clinical 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.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Adults with a confirmed diagnosis of Crohn’s disease (CD) or perianal fistulizing CD
- •Adults with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 to <30 kg/m²) and at least one weight-related condition (hypertension, Type 2 diabetes, dyslipidemia, obstructive sleep apnea, or cardiovascular disease)
- •Adults with moderately to severely active Crohn’s disease (CDAI score at least 220 at baseline)
- •Adults who meet endoscopy requirements (SES-CD score ≥6 for ileal-colonic disease, or ≥4 for isolated ileal disease) within 21 days before the first dose
- •Adults who did not respond well to at least one Crohn’s disease treatment, or lost response, or could not tolerate it
🚫 You may not be able to join if…
- •People with a current diagnosis of ulcerative colitis (UC), inflammatory bowel disease-unclassified, or primary sclerosing cholangitis
- •People with abscess (current or suspected)
- •People who have a stoma, ileoanal pouch, or ostomy
- •People with certain past small bowel surgeries (more than 3 small bowel resections, or total resection >100 cm, short bowel syndrome, or any intestinal/non-intestinal intra-abdominal surgery within 3 months)
- •People with insulin-treated Type 2 diabetes, Type 1 diabetes, or recent/serious low blood sugar problems (including severe hypoglycemia or hypoglycemia unawareness in the prior 6 months), or recent acute active infection
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 18–70
- ✓A BMI around 30 or higher
- ✓Have Obesity / overweight or Type 2 diabetes or Heart / cardiovascular disease or High blood pressure or High cholesterol
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
What you need to know before you apply
What is this study testing?+
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.
Is it safe? Who makes sure of that?+
This is a late-stage study (Phase 3), testing how well the treatment works in more people. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT06937099 · Locations: Alabama · California · Florida · Idaho · Illinois · Indiana · Kentucky · Louisiana · Maryland · Massachusetts · Missouri · New Hampshire · New York · North Carolina · Ohio · Pennsylvania · Rhode Island · South Carolina · Tennessee · Texas · Washington · Wisconsin