Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
Launched by ELI LILLY AND COMPANY · Apr 18, 2025
Trial Information
Current as of July 24, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating the effectiveness and safety of a treatment combining two medications, mirikizumab and tirzepatide, for adults who have Crohn's disease that is moderately to severely active, along with obesity or being overweight. The study aims to see how this combination compares to mirikizumab alone. Participants will be involved for up to 61 weeks, during which they will receive either the combination treatment or a placebo (a non-active treatment).
To be eligible for this trial, participants must have been diagnosed with Crohn's disease for at least three months and have a body mass index (BMI) indicating obesity or being overweight, along with certain related health conditions like high blood pressure or diabetes. They should also have had insufficient response to previous treatments for Crohn's disease. Those with other specific health issues, such as certain types of infections or surgeries, may not be able to participate. If eligible, participants can expect regular check-ups and monitoring throughout the study to assess their condition and the treatment's effects.
Gender
ALL
Eligibility criteria
- Inclusion 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).
- 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, 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 Eli Lilly And Company
Eli Lilly and Company is a global healthcare leader dedicated to creating innovative medicines that improve patient outcomes across a range of therapeutic areas, including diabetes, oncology, immunology, and neurodegenerative diseases. With a rich history of scientific research and a commitment to advancing healthcare, Lilly invests significantly in clinical trials to develop new treatments and enhance existing therapies. The company prioritizes patient safety and ethical standards in its clinical research, fostering collaboration with healthcare professionals and stakeholders to ensure the delivery of high-quality, evidence-based solutions that address unmet medical needs worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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Patients applied
Trial Officials
Contact Lilly at 1-800-LillyRx (1-800-545-5979)
Study Director
Eli Lilly and Company
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported