RECRUITING

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

Description

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 Overview

Study Details

Study overview

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.

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

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

Condition
Ulcerative Colitis
Intervention / Treatment

-

Contacts and Locations

Dothan

Digestive Health Specialists, Dothan, Alabama, United States, 36301

Anaheim

Smart Cures Clinical Research, Anaheim, California, United States, 92806

Beverly Hills

Cedars-Sinai Medical Center, Beverly Hills, California, United States, 90211

Los Alamitos

United Medical Doctors - Los Alamitos, Los Alamitos, California, United States, 90720

Northridge

California Medical Research Associates, Northridge, California, United States, 91324

Miami

Research Associates of South Florida - Miami - Southwest 8th Street, Miami, Florida, United States, 33134

Miami

Gastro Health Research - Miami, Miami, Florida, United States, 33176

Orlando

Orlando Health, Orlando, Florida, United States, 32806

Orlando

Digestive and Liver Center of Florida, Orlando, Florida, United States, 32825

Pensacola

Gastro Health Research - Pensacola, Pensacola, Florida, United States, 32504

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Contact Lilly at 1-800-LillyRx (1-800-545-5979), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2028-04