RECRUITING

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

Description

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.

Study Overview

Study Details

Study overview

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.

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

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

Condition
Crohn's Disease
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 a diagnosis of Crohn's disease (CD) or perianal fistulizing CD established at least 3 months prior to enrollment confirmed by clinical, endoscopic, and histological criteria.
  • * 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 of these 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.
  • * Have a history of CD involving only or predominantly the colon for greater than or equal to 8 years with a surveillance colonoscopy within 1 year prior to baseline must have documented negative results for colorectal dysplasia and cancer.
  • * Have an inadequate response to, loss of response to, or intolerance to:
  • * at least one conventional therapy (such as corticosteroids, oral azathioprine (AZA) or 60-mercaptopurine (6-MP), or oral aminosalicylates (for example, mesalamine, sulfasalazine, olsalazine, balsalazide) and/or,
  • * at least one advanced therapy for CD (defined as: a biologic or biosimilar medication such as anti-tumor necrosis factor (TNF) antibodies, anti-integrin antibodies, Janus kinase (JAK) inhibitors such as upadacitinib, or anti-interleukin (IL)-12p40 antibodies, for example, ustekinumab).
  • * 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, 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.

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

2028-05