RecruitingCrohn's DiseaseObesity or Overweight

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

Eligible age

18–70 yrs

Accepts

All genders

Locations

22 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

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.

Sponsor: Eli Lilly and Company

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.

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