RecruitingPhase 3

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 61 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The maximum duration of this study is up to 61 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well mirikizumab works and how safe it is when given with tirzepatide or a placebo (a treatment with no active drug). It is for adults with moderate to severe active Crohn’s disease who also have obesity or are overweight. The study lasts up to 61 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have confirmed Crohn’s disease, including Crohn’s with abnormal tunnels near the anus.
  • Have a body mass index (BMI, a measure of weight compared with height) of 30 or higher; or a BMI of 27 to under 30 plus high blood pressure, type 2 diabetes, unhealthy blood fat levels, sleep apnea (breathing pauses during sleep), or heart or blood vessel disease.
  • Have moderate to severe active Crohn’s disease, with a Crohn’s Disease Activity Index score of at least 220.
  • Have a bowel camera exam within 21 days before the first study dose. The study’s reviewers must find a Crohn’s score of at least 6 if both the small and large bowel are involved, or at least 4 if only the last part of the small bowel is involved.
  • If Crohn’s has mainly or only affected the colon for at least 8 years, have test results from the past year showing no abnormal precancerous cells or cancer in the colon or rectum.
  • Have tried at least one Crohn’s treatment allowed by the study that did not work well enough, stopped working, or caused side effects you could not tolerate.

Who can't join

  • Have ulcerative colitis, bowel inflammation that cannot be classified, or primary sclerosing cholangitis (a disease that scars the bile ducts).
  • Are missing more than 2 of these 5 bowel sections: the last part of the small bowel, right colon, middle colon, left colon, and rectum.
  • Have or may have an abscess (a pocket of pus), or have a current or recent active infection.
  • Have a stoma or ostomy (a surgically made opening for bowel waste), or an internal pouch joined to the anus.
  • Have had more than 3 surgeries to remove parts of the small bowel, more than 100 centimeters of small bowel removed, short bowel syndrome (too little working small bowel), or any surgery inside the belly within the past 3 months.
  • Have type 1 diabetes or type 2 diabetes treated with insulin.
  • Have had severe low blood sugar, or low blood sugar without noticing warning signs, within 6 months before screening.
  • Have gained or lost more than 5% of your body weight in the past 3 months.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (35)

AL

CA

FL

  • Research Associates of South Florida - Miami - Southwest 8th Street · Miami, FL 33134Alexander Veloso · Principal investigatorMore trials in Miami
  • Gastro Health Research - Miami · Miami, FL 33176Lukasz Kwapisz · Principal investigatorMore trials in Miami
  • Orlando Health · Orlando, FL 32806Udayakumar Navaneethan · Principal investigatorMore trials in Orlando
  • Digestive and Liver Center of Florida · Orlando, FL 32825 · Study contact · 407-384-7388Harinath Sheela · Principal investigatorMore trials in Orlando
  • Gastro Health Research - Pensacola · Pensacola, FL 32504Frederic Newman · Principal investigatorMore trials in Pensacola
  • Precision Clinical Research · Sunrise, FL 33351Jeffrey Schneider · Principal investigatorMore trials in Sunrise

ID

IL

  • Rush University Medical Center · Chicago, IL 60612Atsushi Sakuraba · Principal investigatorMore trials in Chicago

IN

KY

LA

MA

MD

MO

  • Washington University School of Medicine · St Louis, MO 63110Parakkal Deepak · Principal investigatorMore trials in St Louis

NC

NH

  • Dartmouth-Hitchcock Medical Center · Lebanon, NH 03756Corey Siegel · Principal investigatorMore trials in Lebanon

NY

OH

  • Gastro Intestinal Research Institute of Northern Ohio, LLC · Westlake, OH 44145Mousab Tabbaa · Principal investigatorMore trials in Westlake

PA

RI

SC

TN

  • Gastroenterology Center Of The Midsouth · Cordova, TN 38018Ziad Younes · Principal investigatorMore trials in Cordova

TX

WA

WI