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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Mirikizumab

Administered IV

DRUG

Mirikizumab

Administered SC

DRUG

Tirzepatide

Administered SC

DRUG

Placebo

Administered SC

Locations (20)

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