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

Purpose

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.

Conditions

  • Crohn's Disease
  • Obesity or Overweight

Eligibility

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

Inclusion Criteria

  • Have a confirmed diagnosis of Crohn's disease (CD) or perianal fistulizing CD - 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 weight-related comorbid conditions: - hypertension - Type 2 diabetes mellitus (T2DM) - dyslipidemia - obstructive sleep apnea, or - cardiovascular disease. - Have moderately to severely active CD defined by a CDAI score of at least 220 at baseline. - 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. - Participants with a history of CD for ≥8 years involving only or predominantly the colon must have documented negative results for colorectal dysplasia and cancer within 1 year prior to baseline. - Demonstrated inadequate response, loss of response or intolerance to at least one protocol-specified conventional or advanced CD therapy

Exclusion Criteria

  • Have a current diagnosis of Ulcerative Colitis (UC), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis. - Have more than 2 missing segments of the following 5 segments: terminal ileum, ·right colon, transverse colon, ·left colon, and rectum. - Currently have or are suspected to have an abscess. - Have a stoma, ileoanal pouch, or ostomy. - Have a history of more than 3 small bowel resections, total resection of small bowel greater than 100 centimeters (cm), diagnosis of short bowel syndrome, or any intestinal or non-intestinal intra-abdominal surgery within 3 months of baseline. - 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 had more than 5% body weight change in the past 3 months - 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, Alabama 36301
Contact:
334-836-1212

Smart Cures Clinical Research
Anaheim, California 92806

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

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

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

Gastro Health Research - Miami
Miami, Florida 33176

Orlando Health
Orlando, Florida 32806

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

Gastro Health Research - Pensacola
Pensacola, Florida 32504

Precision Clinical Research
Sunrise, Florida 33351

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

Indiana University Health University Hospital
Indianapolis, Indiana 46202

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

Gastroenterology Health Partners
Louisville, Kentucky 40218
Contact:
502-888-1988

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

Louisiana Research Center
Shreveport, Louisiana 71105
Contact:
318-525-3233

Capital Digestive Care - Chevy Chase
Chevy Chase, Maryland 20815

Lucida Clinical Trials
New Bedford, Massachusetts 02740

Washington University School of Medicine
St Louis, Missouri 63110

Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756

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

Care Access - Yonkers
Yonkers, New York 10701

Coastal Research Institute - Fayetteville
Fayetteville, North Carolina 28304

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

Thomas Jefferson University - Medicine/GI and Hepatology
Philadelphia, Pennsylvania 19107
Contact:
215-955-8900

University Gastroenterology
Providence, Rhode Island 02905
Contact:
401-421-8800

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

Gastroenterology Center Of The Midsouth
Cordova, Tennessee 38018

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

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

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

Washington Gastroenterology - Tacoma
Tacoma, Washington 98405
Contact:
253-272-5127

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

CMRC Headlands, LLC
San Juan, 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