RECRUITING

Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study

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Conditions

Ulcerative ColitisObesity 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 show whether in these individuals, treatment with both mirikizumab and tirzepatide, compared with treatment with mirikizumab and placebo, leads to decrease or disappearance of UC symptoms, and loss of at least one-tenth of the overall body weight. Participation in this study will last up to 61 weeks, including 52 weeks of treatment.

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 Ulcerative Colitis and Obesity or Overweight

Quick Facts

Study Start:2025-06-26
Study Completion:2028-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06937086

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 an established diagnosis of UC for ≥3 months before baseline which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC.
  2. * Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5 to 9 points and endoscopic subscore (ES) of 2 to 3 (confirmed by central review) within 21 days before baseline.
  3. * Participants with a history of UC for greater than or equal to 8 years who have had a surveillance colonoscopy completed within 1 year prior to baseline must have documented negative results for colorectal dysplasia and cancer.
  4. * Have obesity, \[body mass index (BMI) 30 kilograms per meter squared (kg/m2)\]
  5. * Have overweight (BMI ≥27 kg/m2 to \<30 kg/m2) and in the presence of at least 1 of these weight-related comorbid conditions:
  6. * hypertension
  7. * Type 2 Diabetes Mellitus (T2DM)
  8. * dyslipidemia
  9. * obstructive sleep apnea, or
  10. * cardiovascular disease.
  11. * Have an inadequate response to, loss of response to, or intolerance to at least 1 of the conventional medication: oral corticosteroids, oral azathioprine (AZA) or 6-mercaptopurine (6-MP), or oral 5-aminosalicylates (for example, mesalamine, sulfasalazine, olsalazine, and balsalazide) and/or who have an inadequate response to or a loss of response to, or are intolerant to advanced therapy for UC, defined as: a biologic or biosimilar medication such as anti-tumor necrosis factor (TNF) antibodies; anti-integrin antibodies, Janus kinase (JAK) inhibitors such as tofacitinib or upadacitinib, sphingosine 1-phosphate receptor 1inhibitors such as etrasimod or ozanimod, or anti-interleukin(IL)-12p40 antibodies, for example, ustekinumab.
  1. * Have a current diagnosis of:
  2. * Crohn's disease
  3. * inflammatory bowel disease (IBD) unclassified (formerly known as indeterminate colitis), or
  4. * primary sclerosing cholangitis.
  5. * Have had or will need bowel resection or intestinal or intra-abdominal surgery.
  6. * Have evidence of toxic megacolon, or stricture or stenosis within the colon that cannot be traversed by a sigmoidoscope or colonoscope.
  7. * Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) or have insulin-treated T2DM.
  8. * Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening.
  9. * Have a self-reported change in body weight greater than 5% (gain or reduction) within 3 months prior to screening.
  10. * 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
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
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
Gastroenterology Consultants of Southwest Virginia
Roanoke, Virginia, 24014
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 Date2028-04

Study Record Updates

Study Start Date2025-06-26
Study Completion Date2028-04

Terms related to this study

Additional Relevant MeSH Terms

  • Ulcerative Colitis
  • Obesity or Overweight