RECRUITING

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

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Conditions

Crohn's DiseaseObesity or Overweight

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 3b, Randomized, Multicenter, Controlled Study of Mirikizumab and Placebo or Mirikizumab Concomitantly Administered With Tirzepatide in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight

Quick Facts

Study Start:2025-06-26
Study Completion:2028-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06937099

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have had a diagnosis of Crohn's disease (CD) or perianal fistulizing CD established at least 3 months prior to enrollment confirmed by clinical, endoscopic, and histological criteria.
  2. * 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 of these weight-related comorbid conditions:
  3. * hypertension
  4. * Type 2 diabetes mellitus (T2DM)
  5. * dyslipidemia
  6. * obstructive sleep apnea, or
  7. * cardiovascular disease.
  8. * Have moderately to severely active CD defined by a CDAI score of at least 220 at baseline.
  9. * 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.
  10. * Have a history of CD involving only or predominantly the colon for greater than or equal to 8 years with a surveillance colonoscopy within 1 year prior to baseline must have documented negative results for colorectal dysplasia and cancer.
  11. * Have an inadequate response to, loss of response to, or intolerance to:
  12. * at least one conventional therapy (such as corticosteroids, oral azathioprine (AZA) or 60-mercaptopurine (6-MP), or oral aminosalicylates (for example, mesalamine, sulfasalazine, olsalazine, balsalazide) and/or,
  13. * at least one advanced therapy for CD (defined as: a biologic or biosimilar medication such as anti-tumor necrosis factor (TNF) antibodies, anti-integrin antibodies, Janus kinase (JAK) inhibitors such as upadacitinib, or anti-interleukin (IL)-12p40 antibodies, for example, ustekinumab).
  1. * Have a current diagnosis of Ulcerative Colitis (UC), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis.
  2. * Have more than 2 missing segments of the following 5 segments: terminal ileum, ·right colon, transverse colon, ·left colon, and rectum.
  3. * Currently have or are suspected to have an abscess.
  4. * Have a stoma, ileoanal pouch, or ostomy.
  5. * Have a history of more than 3 small bowel resections, diagnosis of short bowel syndrome, or any intestinal or non-intestinal intra-abdominal surgery within 3 months of baseline.
  6. * Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) or have insulin-treated T2DM.
  7. * Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening.
  8. * Have had more than 5% body weight change in the past 3 months
  9. * Have a current or recent acute, active infection.

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
3176154559
clinical_inquiry_hub@lilly.com

Principal Investigator

Contact Lilly at 1-800-LillyRx (1-800-545-5979)
STUDY_DIRECTOR
Eli Lilly and Company

Study Locations (Sites)

Digestive Health Specialists
Dothan, Alabama, 36301
United States
Smart Cures Clinical Research
Anaheim, California, 92806
United States
Cedars-Sinai Medical Center
Beverly Hills, California, 90211
United States
United Medical Doctors - Los Alamitos
Los Alamitos, California, 90720
United States
California Medical Research Associates
Northridge, California, 91324
United States
Research Associates of South Florida - Miami - Southwest 8th Street
Miami, Florida, 33134
United States
Gastro Health Research - Miami
Miami, Florida, 33176
United States
Orlando Health
Orlando, Florida, 32806
United States
Digestive and Liver Center of Florida
Orlando, Florida, 32825
United States
Gastro Health Research - Pensacola
Pensacola, Florida, 32504
United States
Precision Clinical Research
Sunrise, Florida, 33351
United States
Grand Teton Research Group
Idaho Falls, Idaho, 83404
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
United States
Gastroenterology Health Partners
New Albany, Indiana, 47150
United States
Gastroenterology Health Partners
Louisville, Kentucky, 40218
United States
Care Access - New Iberia
New Iberia, Louisiana, 70560
United States
Louisiana Research Center
Shreveport, Louisiana, 71105
United States
Capital Digestive Care - Chevy Chase
Chevy Chase, Maryland, 20815
United States
Lucida Clinical Trials
New Bedford, Massachusetts, 02740
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
New York Gastroenterology Associates
New York, New York, 10075
United States
Care Access - Yonkers
Yonkers, New York, 10701
United States
Coastal Research Institute - Fayetteville
Fayetteville, North Carolina, 28304
United States
Gastro Intestinal Research Institute of Northern Ohio, LLC
Westlake, Ohio, 44145
United States
Thomas Jefferson University - Medicine/GI and Hepatology
Philadelphia, Pennsylvania, 19107
United States
University Gastroenterology - Providence - West River Street
Providence, Rhode Island, 02904
United States
Gastroenterology Associates - Patewood
Greenville, South Carolina, 29607
United States
Gastroenterology Center Of The Midsouth
Cordova, Tennessee, 38018
United States
Caprock Gastro Research
Lubbock, Texas, 79424
United States
Gastroenterology Research of San Antonio
San Antonio, Texas, 78229
United States
Southern Star Research Institute
San Antonio, Texas, 78229
United States
Tyler Research Institute
Tyler, Texas, 75701
United States
Washington Gastroenterology - Tacoma
Tacoma, Washington, 98405
United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215
United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

  • Contact Lilly at 1-800-LillyRx (1-800-545-5979), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-26
Study Completion Date2028-05

Study Record Updates

Study Start Date2025-06-26
Study Completion Date2028-05

Terms related to this study

Additional Relevant MeSH Terms

  • Crohn's Disease
  • Obesity or Overweight