RecruitingPhase 3

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

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
  • "Participation in this study will last up to 61 weeks, including 52 weeks of treatment."
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 is for adults with moderate to severe ulcerative colitis (UC), a disease that causes swelling and sores in the colon, who also have obesity or are overweight. It compares mirikizumab plus tirzepatide with mirikizumab plus a placebo (no active drug) to see if symptoms improve or go away and body weight drops by at least 10%. The study lasts up to 61 weeks, including 52 weeks of treatment.

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.

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

Eligibility

Who can join

  • Have had UC for at least 3 months, confirmed by a scope exam of the colon and a tissue sample report.
  • Have moderate to severe active UC, with required scores on symptom checks and a scope exam within 21 days before the study starts.
  • If you have had UC for at least 8 years and had a screening colonoscopy in the past year, its results must show no cancer or abnormal cells that could become cancer.
  • Have obesity, or be overweight with a BMI of 27 to less than 30 and at least one weight-related condition listed below. BMI is a measure of weight compared with height.
  • For people who are overweight, qualifying conditions are high blood pressure, type 2 diabetes, unhealthy blood fat levels, blocked breathing during sleep, or heart or blood vessel disease.
  • Have tried at least one standard or advanced UC medicine that did not work well enough, stopped working, or caused side effects you could not tolerate.

Who can't join

  • Have Crohn’s disease, bowel inflammation that cannot be clearly labeled as UC or Crohn’s, or primary sclerosing cholangitis (a disease that scars the bile ducts).
  • Have had or will need surgery to remove part of the bowel, or other surgery on the intestines or inside the belly.
  • Have dangerous swelling of the colon, or a narrowed area in the colon that a scope cannot pass through.
  • Have type 1 diabetes, or type 2 diabetes treated with insulin.
  • Have had severely low blood sugar, or low blood sugar without warning signs, in the past 6 months.
  • Report gaining or losing more than 5% of your body weight in the past 3 months.
  • Have a current or recent active infection.

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

Official 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.

Study sites (37)

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

VA

  • Gastroenterology Consultants of Southwest Virginia · Roanoke, VA 24014Nirish Shah · Principal investigatorMore trials in Roanoke

WA

WI