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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
Mirikizumab will be open label, tirzepatide and placebo to match will be blinded.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Mirikizumab + Tirzepatide 		Mirikizumab administered intravenously (IV) then Mirikizumab administered subcutaneously (SC). Tirzepatide administered SC.
  • Drug: Mirikizumab
    Administered IV
    Other names:
    • LY3074828
  • Drug: Mirikizumab
    Administered SC
    Other names:
    • LY3074828
  • Drug: Tirzepatide
    Administered SC
    Other names:
    • LY3298176
Experimental
Mirikizumab + Placebo 		Mirikizumab administered IV then Mirikizumab administered SC. Placebo administered SC.
  • Drug: Mirikizumab
    Administered IV
    Other names:
    • LY3074828
  • Drug: Mirikizumab
    Administered SC
    Other names:
    • LY3074828
  • Drug: Placebo
    Administered SC

Recruiting Locations

Digestive Health Specialists
Dothan 4059102, Alabama 4829764 36301
Contact:
334-836-1212

Smart Cures Clinical Research
Anaheim 5323810, California 5332921 92806

United Medical Doctors - Los Alamitos
Los Alamitos 5368304, California 5332921 90720
Contact:
562-430-4449

California Medical Research Associates
Northridge 5377985, California 5332921 91324
Contact:
818-349-1979

Research Associates of South Florida - Miami - Southwest 8th Street
Miami 4164138, Florida 4155751 33134

Gastro Health Research - Miami
Miami 4164138, Florida 4155751 33176

Orlando Health
Orlando 4167147, Florida 4155751 32806

Digestive and Liver Center of Florida
Orlando 4167147, Florida 4155751 32825
Contact:
407-384-7388

Gastro Health Research - Pensacola
Pensacola 4168228, Florida 4155751 32504

Precision Clinical Research
Sunrise 4174402, Florida 4155751 33351

Grand Teton Research Group
Idaho Falls 5596475, Idaho 5596512 83404
Contact:
208-528-4256

Rush University Medical Center
Chicago 4887398, Illinois 4896861 60612

Indiana University Health University Hospital
Indianapolis 4259418, Indiana 4921868 46202

Gastroenterology Health Partners
New Albany 4262045, Indiana 4921868 47150
Contact:
812-206-1702

Gastroenterology Health Partners
Louisville 4299276, Kentucky 6254925 40218

Care Access - New Iberia
New Iberia 4334971, Louisiana 4331987 70560
Contact:
813-851-0135

Louisiana Research Center
Shreveport 4341513, Louisiana 4331987 71105
Contact:
318-525-3227

Lucida Clinical Trials
New Bedford 4945121, Massachusetts 6254926 02740

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110

Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029

New York Gastroenterology Associates
New York 5128581, New York 5128638 10075
Contact:
212-369-2490

Care Access - Yonkers
Yonkers 5145215, New York 5128638 10701

Coastal Research Institute - Fayetteville
Fayetteville 4466033, North Carolina 4482348 28304

Gastro Intestinal Research Institute of Northern Ohio, LLC
Westlake 5176517, Ohio 5165418 44145

University Gastroenterology - Providence - West River Street
Providence 5224151, Rhode Island 5224323 02904
Contact:
401-421-8800

Gastroenterology Associates - Patewood
Greenville 4580543, South Carolina 4597040 29607
Contact:
864-451-5026

Gastroenterology Center Of The Midsouth
Cordova 4050552, Tennessee 4662168 38018

Gastroenterology Research of San Antonio
San Antonio 4726206, Texas 4736286 78229
Contact:
210-615-3848

Southern Star Research Institute
San Antonio 4726206, Texas 4736286 78229
Contact:
210-581-2812

Tyler Research Institute
Tyler 4738214, Texas 4736286 75701
Contact:
903-630-6211

Gastroenterology Consultants of Southwest Virginia
Roanoke 4782167, Virginia 6254928 24014

Washington Gastroenterology - Tacoma
Tacoma 5812944, Washington 5815135 98405

Wisconsin Center for Advanced Research
Milwaukee 5263045, Wisconsin 5279468 53215
Contact:
414-908-6500

CMRC Headlands, LLC
San Juan 4568127, Puerto Rico 00918

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.