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New treatment option for Crohn's Disease
Official title Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
ClinicalTrials.gov ID: NCT06937099
What this study is testing
What is Mirikizumab?
Mirikizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for crohn's disease.
Also referred to as LY3074828.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- hypertension
- Type 2 diabetes mellitus (T2DM)
- dyslipidemia
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...
- 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...
- Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) or have insulin-treated T2DM.
See the full eligibility 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Dothan, Alabama, United States
- Anaheim, California, United States
- Beverly Hills, California, United States
- Los Alamitos, California, United States
- Northridge, California, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Pensacola, Florida, United States
- Sunrise, Florida, United States
- Idaho Falls, Idaho, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- New Albany, Indiana, United States
- Louisville, Kentucky, United States
- New Iberia, Louisiana, United States
- Shreveport, Louisiana, United States
- Chevy Chase, Maryland, United States
- New Bedford, Massachusetts, United States
- St Louis, Missouri, United States
- Lebanon, New Hampshire, United States
+ 142 more site(s).
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, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dothan, Alabama, United States; Anaheim, California, United States; Beverly Hills, California, United States; Los Alamitos, California, United States; Northridge, California, United States; Miami, Florida, United States and 156 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.