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
Sponsored by Eli Lilly and Company
About this study
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.
Where this study is enrolling (20)
- Call 334-836-1212
Digestive Health Specialists
Dothan, Alabama
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- Call 562-430-4449
United Medical Doctors - Los Alamitos
Los Alamitos, California
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- Call 310-423-4100
Cedars-Sinai Medical Center
Beverly Hills, California
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- Call 818-349-1979
California Medical Research Associates
Northridge, California
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- Call 407-384-7388
Digestive and Liver Center of Florida
Orlando, Florida
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Show all 20 locations
- Call 208-528-4256
Grand Teton Research Group
Idaho Falls, Idaho
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- I'm interested
Rush University Medical Center
Chicago, Illinois
- Call 812-206-1702
Gastroenterology Health Partners
New Albany, Indiana
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- Call 502-888-1988
Gastroenterology Health Partners
Louisville, Kentucky
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- Call 813-851-0135
Care Access - New Iberia
New Iberia, Louisiana
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- Call 318-525-3233
Louisiana Research Center
Shreveport, Louisiana
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- Call 212-369-2490
New York Gastroenterology Associates
New York, New York
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- Call 215-955-8900
Thomas Jefferson University - Medicine/GI and Hepatology
Philadelphia, Pennsylvania
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- Call 401-421-8800
University Gastroenterology
Providence, Rhode Island
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- Call 864-451-5026
Gastroenterology Associates - Patewood
Greenville, South Carolina
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- Call 903-630-6211
Tyler Research Institute
Tyler, Texas
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- Call 210-615-3848
Gastroenterology Research of San Antonio
San Antonio, Texas
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- Call 210-581-2812
Southern Star Research Institute
San Antonio, Texas
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- Call 253-272-5127
Washington Gastroenterology - Tacoma
Tacoma, Washington
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- Call 414-908-6500
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin
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Who can participate
Inclusion criteria
- ✓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.
- ✓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.
- ✓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.
- ✓Have obesity, \[body mass index (BMI) 30 kilograms per meter squared (kg/m2)\]
- ✓Have overweight (BMI ≥27 kg/m2 to \<30 kg/m2) and in the presence of at least 1 of these weight-related comorbid conditions:
- ✓hypertension
- ✓Type 2 Diabetes Mellitus (T2DM)
- ✓dyslipidemia
- ✓obstructive sleep apnea, or
- ✓cardiovascular disease.
- ✓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.
Exclusion criteria
- ✕Have a current diagnosis of:
- ✕Crohn's disease
- ✕inflammatory bowel disease (IBD) unclassified (formerly known as indeterminate colitis), or
- ✕primary sclerosing cholangitis.
- ✕Have had or will need bowel resection or intestinal or intra-abdominal surgery.
- ✕Have evidence of toxic megacolon, or stricture or stenosis within the colon that cannot be traversed by a sigmoidoscope or colonoscope.
- ✕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 a self-reported change in body weight greater than 5% (gain or reduction) within 3 months prior to screening.
- ✕Have a current or recent acute, active infection.
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.