NCT06937086From ClinicalTrials.govRecruiting

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

Ulcerative Colitis
Obesity or Overweight

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Eli Lilly and Company
Enrolment target: 350
Started: 26 June 2025
Main results due: April 2028
Study sites: 187
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 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.

What this study is about

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

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.

Study sites(187)

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
Icahn School of Medicine at Mount Sinai
New York, New York, 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
Gastroenterology Consultants of Southwest Virginia
Roanoke, Virginia, 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

Showing 60 of 187 sites — filter to narrow it down. 176 of the 187 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 NCT06937086. 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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