NCT06937099From ClinicalTrials.govRecruiting

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

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 Crohn's Disease and Obesity or Overweight

Crohn's Disease
Obesity or Overweight

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Eli Lilly and Company
Enrolment target: 290
Started: 26 June 2025
Main results due: May 2028
Study sites: 183
Registry updated: 24 September 2026

Can you take part?

Ages 18 years to 70 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(183)

Digestive Health Specialists
Dothan, Alabama, United States
Recruiting
Smart Cures Clinical Research
Anaheim, California, United States
Recruiting
Cedars-Sinai Medical Center
Beverly Hills, California, United States
Recruiting
United Medical Doctors - Los Alamitos
Los Alamitos, California, United States
Recruiting
California Medical Research Associates
Northridge, California, United States
Recruiting
Research Associates of South Florida - Miami - Southwest 8th Street
Miami, Florida, United States
Recruiting
Gastro Health Research - Miami
Miami, Florida, United States
Recruiting
Orlando Health
Orlando, Florida, United States
Recruiting
Digestive and Liver Center of Florida
Orlando, Florida, United States
Recruiting
Gastro Health Research - Pensacola
Pensacola, Florida, United States
Recruiting
Precision Clinical Research
Sunrise, Florida, United States
Recruiting
Grand Teton Research Group
Idaho Falls, Idaho, United States
Recruiting
Rush University Medical Center
Chicago, Illinois, United States
Recruiting
Indiana University Health University Hospital
Indianapolis, Indiana, United States
Recruiting
Gastroenterology Health Partners
New Albany, Indiana, United States
Recruiting
Gastroenterology Health Partners
Louisville, Kentucky, United States
Recruiting
Care Access - New Iberia
New Iberia, Louisiana, United States
Recruiting
Louisiana Research Center
Shreveport, Louisiana, United States
Recruiting
Capital Digestive Care - Chevy Chase
Chevy Chase, Maryland, United States
Recruiting
Lucida Clinical Trials
New Bedford, Massachusetts, United States
Recruiting
Washington University School of Medicine
St Louis, Missouri, United States
Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Recruiting
New York Gastroenterology Associates
New York, New York, United States
Recruiting
Care Access - Yonkers
Yonkers, New York, United States
Recruiting
Coastal Research Institute - Fayetteville
Fayetteville, North Carolina, United States
Recruiting
Gastro Intestinal Research Institute of Northern Ohio, LLC
Westlake, Ohio, United States
Recruiting
Thomas Jefferson University - Medicine/GI and Hepatology
Philadelphia, Pennsylvania, United States
Recruiting
University Gastroenterology
Providence, Rhode Island, United States
Recruiting
Gastroenterology Associates - Patewood
Greenville, South Carolina, United States
Recruiting
Gastroenterology Center Of The Midsouth
Cordova, Tennessee, United States
Recruiting
Gastroenterology Research of San Antonio
San Antonio, Texas, United States
Recruiting
Southern Star Research Institute
San Antonio, Texas, United States
Recruiting
Tyler Research Institute
Tyler, Texas, United States
Recruiting
Washington Gastroenterology - Tacoma
Tacoma, Washington, United States
Recruiting
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States
Recruiting
Medizinische Universität Graz
Graz, Austria
Recruiting
Medizinische Universitaet Innsbruck
Innsbruck, Austria
Recruiting
Medizinische Universität Wien
Vienna, Austria
Recruiting
AZORG Campus Aalst-Moorselbaan
Aalst, Belgium
Recruiting
Université Libre de Bruxelles - Hôpital Erasme
Brussels, Belgium
Recruiting
AZ Groeninge Campus Kennedylaan
Kortrijk, Belgium
Recruiting
UZ Leuven
Leuven, Belgium
Recruiting
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, Belgium
Recruiting
Clinical Chc Montlégia
Liège, Belgium
Recruiting
NewData Clinical Research - Aracaju
Aracaju, Brazil
Recruiting
L2IP - Instituto de Pesquisas Clínicas
Brasília, Brazil
Recruiting
Loema Instituto de Pesquisa Clinica
Campinas, Brazil
Recruiting
Fundação Universidade de Caxias do Sul (FUCS)
Caxias do Sul, Brazil
Recruiting
Centro Digestivo de Curitiba
Curitiba, Brazil
Recruiting
Galileo Medical Research
Juiz de Fora, Brazil
Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil
Recruiting
Hospital de Clínicas de Ribeirão Preto
Ribeirão Preto, Brazil
Recruiting
CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e Nutrição
Salvador, Brazil
Recruiting
Pesquisare Saude
Santo André, Brazil
Recruiting
CPQuali Pesquisa Clínica
São Paulo, Brazil
Recruiting
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, Brazil
Recruiting
Clínica Hepatogastro JK
São Paulo, Brazil
Recruiting
CEDOES
Vitória, Brazil
Recruiting
Integral Pesquisa e Ensino
Votuporanga, Brazil
Recruiting
University Hospital "St. Ivan Rilski"
Gorna Oryahovitsa, Bulgaria
Recruiting

Showing 60 of 183 sites — filter to narrow it down. 171 of the 183 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06937099. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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