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Clinical Trials in Germany / NCT06937099
Recruiting Phase 3

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

NCT06937099 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2025-06-26
Last updated
2026-09-24

Condition(s) studied

Crohn's DiseaseObesity or Overweight

Investigational drug(s) / intervention(s)

Mirikizumab →Mirikizumab →Tirzepatide →Placebo

Mirikizumab: Administered IV

Mirikizumab: Administered SC

Tirzepatide: Administered SC

Placebo: Administered SC

Study 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 moderately to severely active CD and obesity, or overweight.

The maximum duration of this study is up to 61 weeks.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (183)

FacilityCityRegionStatus
Digestive Health Specialists Dothan Alabama Recruiting
Smart Cures Clinical Research Anaheim California Recruiting
Cedars-Sinai Medical Center Beverly Hills California Recruiting
United Medical Doctors - Los Alamitos Los Alamitos California Recruiting
California Medical Research Associates Northridge California Recruiting
Research Associates of South Florida - Miami - Southwest 8th Street Miami Florida Recruiting
Gastro Health Research - Miami Miami Florida Recruiting
Orlando Health Orlando Florida Recruiting
Digestive and Liver Center of Florida Orlando Florida Recruiting
Gastro Health Research - Pensacola Pensacola Florida Recruiting
Precision Clinical Research Sunrise Florida Recruiting
Grand Teton Research Group Idaho Falls Idaho Recruiting
Rush University Medical Center Chicago Illinois Recruiting
Indiana University Health University Hospital Indianapolis Indiana Recruiting
Gastroenterology Health Partners New Albany Indiana Recruiting
Gastroenterology Health Partners Louisville Kentucky Recruiting
Care Access - New Iberia New Iberia Louisiana Recruiting
Louisiana Research Center Shreveport Louisiana Recruiting
Capital Digestive Care - Chevy Chase Chevy Chase Maryland Recruiting
Lucida Clinical Trials New Bedford Massachusetts Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire Recruiting
New York Gastroenterology Associates New York New York Recruiting
Care Access - Yonkers Yonkers New York Recruiting
Coastal Research Institute - Fayetteville Fayetteville North Carolina Recruiting
Gastro Intestinal Research Institute of Northern Ohio, LLC Westlake Ohio Recruiting
Thomas Jefferson University - Medicine/GI and Hepatology Philadelphia Pennsylvania Recruiting
University Gastroenterology Providence Rhode Island Recruiting
Gastroenterology Associates - Patewood Greenville South Carolina Recruiting
Gastroenterology Center Of The Midsouth Cordova Tennessee Recruiting
Gastroenterology Research of San Antonio San Antonio Texas Recruiting
Southern Star Research Institute San Antonio Texas Recruiting
Tyler Research Institute Tyler Texas Recruiting
Washington Gastroenterology - Tacoma Tacoma Washington Recruiting
Wisconsin Center for Advanced Research Milwaukee Wisconsin Recruiting
Medizinische Universität Graz Graz Austria Recruiting
Medizinische Universitaet Innsbruck Innsbruck Austria Recruiting
Medizinische Universität Wien Vienna Austria Recruiting
AZORG Campus Aalst-Moorselbaan Aalst Belgium Recruiting
Université Libre de Bruxelles - Hôpital Erasme Brussels Belgium Recruiting

+ 143 more sites — see the full list on the official registry below.

On this site

📄 Omvoh (mirikizumab) drug profile → 📄 Mounjaro (tirzepatide) drug profile →

More Eli Lilly and Company trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06937099 on ClinicalTrials.gov ↗ ← All trials in Germany