Mirikizumab with or without tirzepatide for adults with moderately to severely active Crohn's disease who are overweight or have obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial compares mirikizumab plus placebo to mirikizumab with concomitant tirzepatide in adults who have moderately to severely active Crohn's disease and are overweight or have obesity. Eligible participants must meet clinical activity (CDAI ≥220) and endoscopic (SES-CD) thresholds and will be treated and followed for up to 61 weeks. Study procedures include scheduled administration of mirikizumab with either tirzepatide or matching placebo, central endoscopic reads, and regular safety and efficacy assessments including disease activity and weight-related outcomes. The trial is designed to measure both Crohn's disease response and safety while also observing effects on weight and metabolic comorbidities.

Why it matters

Who can join: the full rules

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.

Where it's running

• Digestive Health Specialists
  Dothan, Alabama, United States Recruiting
• Smart Cures Clinical Research
  Anaheim, California, United States Recruiting
• Cedars-Sinai Medical Center
  Beverly Hills, California, United States Recruiting
• United Medical Doctors - Los Alamitos
  Los Alamitos, California, United States Recruiting
• California Medical Research Associates
  Northridge, California, United States Recruiting
• Research Associates of South Florida - Miami - Southwest 8th Street
  Miami, Florida, United States Recruiting

+133 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Mirikizumab given at the same time as tirzepatide for adults with moderate-to-severe ulcerative colitis who are overweight or have obesity

  This will test whether giving mirikizumab together with tirzepatide helps adults with moderate-to-severe ulcerative colitis who are overweight or obese reduce UC symptoms and lose at least 10% of their body weight.

  Recruiting at 179 sites Phase 3 Eli Lilly and Company · Dothan, Alabama and 185 other locations · NCT06937086

• Evaluating Mirikizumab for Children with Crohn's Disease

  This study is testing a new medication called mirikizumab to see if it helps children with Crohn's disease feel better and manage their symptoms.

  Recruiting at 71 sites Phase 3 Eli Lilly and Company · Los Angeles, California and 80 other locations · NCT05509777

• Evaluating Mirikizumab for Children with Ulcerative Colitis or Crohn's Disease

  This study is testing if a medication called mirikizumab can help children with ulcerative colitis or Crohn's disease feel better over a long period of time.

  Recruiting at 39 sites Phase 3 Eli Lilly and Company · San Francisco, California and 68 other locations · NCT04844606

• Iron treatment for children and young adults with Crohn’s disease and iron deficiency anemia

  This study tests how different iron treatment approaches work for kids and young adults with Crohn’s disease and iron deficiency anemia.

  Recruiting Phase 4 Weill Medical College of Cornell University · New York, New York · NCT07925450

• Petrelintide for weight management in adults with overweight or obesity

  This study tests whether petrelintide helps people with overweight or obesity lose weight when combined with a reduced-calorie diet and more exercise, compared with a placebo.

  Recruiting at 8 sites Phase 3 Hoffmann-La Roche · Anniston, Alabama and 7 other locations · NCT07843498

• Petrelintide for weight management in adults with overweight/obesity and type 2 diabetes

  This study tests whether petrelintide, added to a reduced-calorie diet and more physical activity, helps people with overweight or obesity and type 2 diabetes lose weight more effectively than a placebo.

  Recruiting at 2 sites Phase 3 Hoffmann-La Roche · Los Angeles, California and 1 other locations · NCT07843485

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.