Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Crohn's Disease, Obesity or Overweight

In brief

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.

Key facts

Study ID

NCT06937099

Run by

Eli Lilly and Company

People needed

290

Starts

2025-06-26

Expected to finish

2028-05-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 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

You may not qualify 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.
• 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 it is running

• Smart Cures Clinical Research — Anaheim, California, United States (enrolling)
• Cedars-Sinai Medical Center — Beverly Hills, California, United States (enrolling)
• United Medical Doctors - Los Alamitos — Los Alamitos, California, United States (enrolling)
• California Medical Research Associates — Northridge, California, United States (enrolling)
• Research Associates of South Florida - Miami - Southwest 8th Street — Miami, Florida, United States (enrolling)
• Gastro Health Research - Miami — Miami, Florida, United States (enrolling)
• Orlando Health — Orlando, Florida, United States (enrolling)
• Digestive and Liver Center of Florida — Orlando, Florida, United States (enrolling)
• Gastro Health Research - Pensacola — Pensacola, Florida, United States (enrolling)
• Precision Clinical Research — Sunrise, Florida, United States (enrolling)
• Grand Teton Research Group — Idaho Falls, Idaho, United States (enrolling)
• Rush University Medical Center — Chicago, Illinois, United States (enrolling)
• Indiana University Health University Hospital — Indianapolis, Indiana, United States (enrolling)
• Gastroenterology Health Partners — New Albany, Indiana, United States (enrolling)
• Gastroenterology Health Partners — Louisville, Kentucky, United States (enrolling)
• Care Access - New Iberia — New Iberia, Louisiana, United States (enrolling)
• Louisiana Research Center — Shreveport, Louisiana, United States (enrolling)
• Capital Digestive Care - Chevy Chase — Chevy Chase, Maryland, United States (enrolling)
• Lucida Clinical Trials — New Bedford, Massachusetts, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
• New York Gastroenterology Associates — New York, New York, United States (enrolling)
• Care Access - Yonkers — Yonkers, New York, United States (enrolling)
• Coastal Research Institute - Fayetteville — Fayetteville, North Carolina, United States (enrolling)
• Digestive Health Specialists — Dothan, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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