Status:
RECRUITING
Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
Lead Sponsor:
Eli Lilly and Company
Conditions:
Crohn's Disease
Obesity or Overweight
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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 moderat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT06937099
Start Date
June 26 2025
End Date
May 1 2028
Last Update
December 18 2025
Active Locations (187)
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1
Digestive Health Specialists
Dothan, Alabama, United States, 36301
2
Smart Cures Clinical Research
Anaheim, California, United States, 92806
3
Cedars-Sinai Medical Center
Beverly Hills, California, United States, 90211
4
United Medical Doctors - Los Alamitos
Los Alamitos, California, United States, 90720