Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
Recruiting · NCT06937099 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 is running
60 locations listed across 22 US states.
- Digestive Health Specialists - Dothan, Alabama, United States
- Smart Cures Clinical Research - Anaheim, California, United States
- Cedars-Sinai Medical Center - Beverly Hills, California, United States
- United Medical Doctors - Los Alamitos - Los Alamitos, California, United States
- California Medical Research Associates - Northridge, California, United States
- Research Associates of South Florida - Miami - Southwest 8th Street - Miami, Florida, United States
- Gastro Health Research - Miami - Miami, Florida, United States
- Orlando Health - Orlando, Florida, United States
- Digestive and Liver Center of Florida - Orlando, Florida, United States
- Gastro Health Research - Pensacola - Pensacola, Florida, United States
- Precision Clinical Research - Sunrise, Florida, United States
- Grand Teton Research Group - Idaho Falls, Idaho, United States
- Rush University Medical Center - Chicago, Illinois, United States
- Indiana University Health University Hospital - Indianapolis, Indiana, United States
- Gastroenterology Health Partners - New Albany, Indiana, United States
- Gastroenterology Health Partners - Louisville, Kentucky, United States
- Care Access - New Iberia - New Iberia, Louisiana, United States
- Louisiana Research Center - Shreveport, Louisiana, United States
- Capital Digestive Care - Chevy Chase - Chevy Chase, Maryland, United States
- Lucida Clinical Trials - New Bedford, Massachusetts, United States
- Washington University School of Medicine - St Louis, Missouri, United States
- Dartmouth-Hitchcock Medical Center - Lebanon, New Hampshire, United States
- New York Gastroenterology Associates - New York, New York, United States
- Care Access - Yonkers - Yonkers, New York, United States
- Coastal Research Institute - Fayetteville - Fayetteville, North Carolina, United States
- Gastro Intestinal Research Institute of Northern Ohio, LLC - Westlake, Ohio, United States
- Thomas Jefferson University - Medicine/GI and Hepatology - Philadelphia, Pennsylvania, United States
- University Gastroenterology - Providence, Rhode Island, United States
- Gastroenterology Associates - Patewood - Greenville, South Carolina, United States
- Gastroenterology Center Of The Midsouth - Cordova, Tennessee, United States
- Gastroenterology Research of San Antonio - San Antonio, Texas, United States
- Southern Star Research Institute - San Antonio, Texas, United States
- Tyler Research Institute - Tyler, Texas, United States
- Washington Gastroenterology - Tacoma - Tacoma, Washington, United States
- Wisconsin Center for Advanced Research - Milwaukee, Wisconsin, United States
- AZORG Campus Aalst-Moorselbaan - Aalst, Belgium
- Aarhus Universitetshospital, Skejby - Aarhus, Denmark
- San Peregrino Unidad de Investigación - Aguascalientes, Mexico
- Amsterdam UMC, locatie VUmc - Amsterdam, Netherlands
- Gazi University Health Research and Application Center Gazi Hospital - Ankara, Turkey (Türkiye)
- NewData Clinical Research - Aracaju - Aracaju, Brazil
- Assuta Ashdod Medical Center - Ashdod, Israel
- Evangelismos General Hospital of Athens - Athens, Greece
- Thoracic General Hospital of Athens "I Sotiria" - Athens, Greece
- Spitalul Județean de Urgență Bacău - Bacau, Romania
- Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica - Banská Bystrica, Slovakia
- Centro Médico Teknon - Barcelona, Spain
- Hospital Universitari Vall d'Hebron - Barcelona, Spain
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola - Bologna, Italy
- L2IP - Instituto de Pesquisas Clínicas - Brasília, Brazil
- Cliniq s.r.o. - Bratislava, Slovakia
- SurGal Clinic - Brno, Czechia
- Université Libre de Bruxelles - Hôpital Erasme - Brussels, Belgium
- Spitalul Clinic Colentina - Bucharest, Romania
- Spitalul Universitar de Urgență București - Bucharest, Romania
- Semmelweis Egyetem - Budapest, Hungary
- Semmelweis Egyetem - Budapest, Hungary
- Uludag Universitesi - Bursa, Turkey (Türkiye)
- Loema Instituto de Pesquisa Clinica - Campinas, Brazil
- Ospedale Specializzato in Gastroenterologia "Saverio de Bellis" - Castellana Grotte, Italy
Showing 60 of 183 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →