🔎 Trials Near Me

Home › Ulcerative Colitis › NCT06937086

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

RecruitingPhase 3

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

Who can join

Ages 18 to 70 · All sexes

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.

About the study

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.

What is being tested

Sponsor: Eli Lilly and Company · Participants: 350 · Started: Jun 26, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06937086

Locations in the U.S.

AlabamaDigestive Health Specialists, Dothan
CaliforniaSmart Cures Clinical Research, Anaheim
Cedars-Sinai Medical Center, Beverly Hills
United Medical Doctors - Los Alamitos, Los Alamitos
California Medical Research Associates, Northridge
FloridaGastro Health Research - Miami, Miami
Research Associates of South Florida - Miami - Southwest 8th Street, Miami
Digestive and Liver Center of Florida, Orlando
Orlando Health, Orlando
Gastro Health Research - Pensacola, Pensacola
Precision Clinical Research, Sunrise
IdahoGrand Teton Research Group, Idaho Falls
IllinoisRush University Medical Center, Chicago
IndianaIndiana University Health University Hospital, Indianapolis
Gastroenterology Health Partners, New Albany
KentuckyGastroenterology Health Partners, Louisville
LouisianaCare Access - New Iberia, New Iberia
Louisiana Research Center, Shreveport
MarylandCapital Digestive Care - Chevy Chase, Chevy Chase
MassachusettsLucida Clinical Trials, New Bedford
MissouriWashington University School of Medicine, St Louis
New HampshireDartmouth-Hitchcock Medical Center, Lebanon
New YorkIcahn School of Medicine at Mount Sinai, New York
New York Gastroenterology Associates, New York
Care Access - Yonkers, Yonkers
North CarolinaCoastal Research Institute - Fayetteville, Fayetteville
OhioGastro Intestinal Research Institute of Northern Ohio, LLC, Westlake
PennsylvaniaThomas Jefferson University - Medicine/GI and Hepatology, Philadelphia
Rhode IslandUniversity Gastroenterology, Providence
South CarolinaGastroenterology Associates - Patewood, Greenville
TennesseeGastroenterology Center Of The Midsouth, Cordova
TexasGastroenterology Research of San Antonio, San Antonio
Southern Star Research Institute, San Antonio
Tyler Research Institute, Tyler
VirginiaGastroenterology Consultants of Southwest Virginia, Roanoke
WashingtonWashington Gastroenterology - Tacoma, Tacoma
WisconsinWisconsin Center for Advanced Research, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.