Recruiting

Phase 3

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

Sponsor:

Eli Lilly and Company

Code:

NCT06937099

Conditions

Crohn's Disease

Obesity or Overweight

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Mirikizumab

Tirzepatide

Placebo

Study Details

Brief summary:

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

Study ID

NCT06937099

Start date

Jun 26, 2025

Status verified date

Sep, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Enrollment

290 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mirikizumab + Tirzepatide

Mirikizumab administered intravenously (IV) then Mirikizumab administered subcutaneously (SC).

Tirzepatide administered SC.

experimental: Mirikizumab + Placebo

Mirikizumab administered IV then Mirikizumab administered SC. Placebo administered SC.

Interventions

Mirikizumab

Administered IV

Mirikizumab

Administered SC

Tirzepatide

Administered SC

Placebo

Administered SC

Primary outcome measure

Percentage of Participants Who Simultaneously Achieve Clinical Remission by Crohn's Disease Activity Index (CDAI), Endoscopic Remission, and at least 10% Weight Reduction [ Time Frame: Week 52 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Digestive Health Specialists

Recruiting

Dothan, Alabama, United States, 36301

Contacts

334-836-1212

Principal Investigator:

Paul Lamb

Smart Cures Clinical Research

Recruiting

Anaheim, California, United States, 92806

Principal Investigator:

Dennis Riff

Cedars-Sinai Medical Center

Recruiting

Beverly Hills, California, United States, 90211

Contacts

310-423-4100

Principal Investigator:

Andres Yarur

United Medical Doctors - Los Alamitos

Recruiting

Los Alamitos, California, United States, 90720

Contacts

562-430-4449

Principal Investigator:

Seyedehsan Navabi

California Medical Research Associates

Recruiting

Northridge, California, United States, 91324

Contacts

818-349-1979

Principal Investigator:

Calin Arimie

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

Recruiting

Miami, Florida, United States, 33134

Principal Investigator:

Alexander Veloso

Gastro Health Research - Miami

Recruiting

Miami, Florida, United States, 33176

Principal Investigator:

Lukasz Kwapisz

Orlando Health

Recruiting

Orlando, Florida, United States, 32806

Principal Investigator:

Udayakumar Navaneethan

Digestive and Liver Center of Florida

Recruiting

Orlando, Florida, United States, 32825

Contacts

407-384-7388

Principal Investigator:

Harinath Sheela

Gastro Health Research - Pensacola

Recruiting

Pensacola, Florida, United States, 32504

Principal Investigator:

Frederic Newman

Precision Clinical Research

Recruiting

Sunrise, Florida, United States, 33351

Principal Investigator:

Jeffrey Schneider

Grand Teton Research Group

Recruiting

Idaho Falls, Idaho, United States, 83404

Contacts

208-528-4256

Principal Investigator:

Todd Williams

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Principal Investigator:

Atsushi Sakuraba

Indiana University Health University Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Principal Investigator:

Monika Fischer

Gastroenterology Health Partners

Recruiting

New Albany, Indiana, United States, 47150

Contacts

812-206-1702

Principal Investigator:

Robert Luckett

Gastroenterology Health Partners

Recruiting

Louisville, Kentucky, United States, 40218

Contacts

502-888-1988

Principal Investigator:

Michael Krease

Care Access - New Iberia

Recruiting

New Iberia, Louisiana, United States, 70560

Contacts

813-851-0135

Principal Investigator:

Son Nguyen

Louisiana Research Center

Recruiting

Shreveport, Louisiana, United States, 71105

Contacts

318-525-3233

Principal Investigator:

John Provenza

Capital Digestive Care - Chevy Chase

Recruiting

Chevy Chase, Maryland, United States, 20815

Principal Investigator:

Erica Cohen

Lucida Clinical Trials

Recruiting

New Bedford, Massachusetts, United States, 02740

Principal Investigator:

Paul Sepe

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Principal Investigator:

Parakkal Deepak

Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Principal Investigator:

Corey Siegel

New York Gastroenterology Associates

Recruiting

New York, New York, United States, 10075

Contacts

212-369-2490

Principal Investigator:

Arthur Kornbluth

Care Access - Yonkers

Recruiting

Yonkers, New York, United States, 10701

Principal Investigator:

Peter Wayne

Coastal Research Institute - Fayetteville

Recruiting

Fayetteville, North Carolina, United States, 28304

Principal Investigator:

John Poulos

Gastro Intestinal Research Institute of Northern Ohio, LLC

Recruiting

Westlake, Ohio, United States, 44145

Principal Investigator:

Mousab Tabbaa

Thomas Jefferson University - Medicine/GI and Hepatology

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

215-955-8900

Principal Investigator:

Priya Sehgal

University Gastroenterology

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

401-421-8800

Principal Investigator:

Lisa Mueller

Gastroenterology Associates - Patewood

Recruiting

Greenville, South Carolina, United States, 29607

Contacts

864-451-5026

Principal Investigator:

Matthew Barnes

Gastroenterology Center Of The Midsouth

Recruiting

Cordova, Tennessee, United States, 38018

Principal Investigator:

Ziad Younes

Gastroenterology Research of San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

210-615-3848

Principal Investigator:

Charles Randall

Southern Star Research Institute

Recruiting

San Antonio, Texas, United States, 78229

Contacts

210-581-2812

Principal Investigator:

Jeff Bullock

Tyler Research Institute

Recruiting

Tyler, Texas, United States, 75701

Contacts

903-630-6211

Principal Investigator:

George DuVall

Washington Gastroenterology - Tacoma

Recruiting

Tacoma, Washington, United States, 98405

Contacts

253-272-5127

Principal Investigator:

William Holderman

Wisconsin Center for Advanced Research

Recruiting

Milwaukee, Wisconsin, United States, 53215

Contacts

414-908-6500

Principal Investigator:

Chetan Mittal

London Health Sciences Centre

Recruiting

London, Canada, N6A 5W9

Contacts

519-685-8500

Principal Investigator:

Terry Ponich

London Digestive Disease Institute

Recruiting

London, Canada, N6K 1M6

Principal Investigator:

Vipul Jairath

Clinique IMD

Recruiting

Montreal, Canada, H3H 1E8

Contacts

514-798-0550

Principal Investigator:

Waqqas Afif

(G.I.R.I.) GI Research Institute Foundation

Recruiting

Vancouver, Canada, V5Z 2K5

Principal Investigator:

Greg Rosenfeld

More Information

Sponsor

Eli Lilly and Company

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-09-04.