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

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 Crohn's Disease and Obesity or Overweight

Who can join

Ages 18 to 70 · All sexes

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.

About the study

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.

What is being tested

Sponsor: Eli Lilly and Company · Participants: 290 · Started: Jun 26, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06937099

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 YorkNew 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
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.