Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
Sponsored by Eli Lilly and Company
About 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.
Where this study is enrolling (20)
- Call 334-836-1212
Digestive Health Specialists
Dothan, Alabama
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- Call 562-430-4449
United Medical Doctors - Los Alamitos
Los Alamitos, California
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- Call 310-423-4100
Cedars-Sinai Medical Center
Beverly Hills, California
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- Call 818-349-1979
California Medical Research Associates
Northridge, California
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- Call 407-384-7388
Digestive and Liver Center of Florida
Orlando, Florida
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Show all 20 locations
- Call 208-528-4256
Grand Teton Research Group
Idaho Falls, Idaho
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- I'm interested
Rush University Medical Center
Chicago, Illinois
- Call 812-206-1702
Gastroenterology Health Partners
New Albany, Indiana
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- Call 502-888-1988
Gastroenterology Health Partners
Louisville, Kentucky
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- Call 318-525-3233
Louisiana Research Center
Shreveport, Louisiana
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- Call 813-851-0135
Care Access - New Iberia
New Iberia, Louisiana
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- Call 212-369-2490
New York Gastroenterology Associates
New York, New York
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- Call 215-955-8900
Thomas Jefferson University - Medicine/GI and Hepatology
Philadelphia, Pennsylvania
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- Call 401-421-8800
University Gastroenterology
Providence, Rhode Island
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- Call 864-451-5026
Gastroenterology Associates - Patewood
Greenville, South Carolina
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- Call 903-630-6211
Tyler Research Institute
Tyler, Texas
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- Call 210-581-2812
Southern Star Research Institute
San Antonio, Texas
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- Call 210-615-3848
Gastroenterology Research of San Antonio
San Antonio, Texas
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- Call 253-272-5127
Washington Gastroenterology - Tacoma
Tacoma, Washington
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- Call 414-908-6500
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin
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Who can participate
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.
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.