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
Launched by ELI LILLY AND COMPANY · Apr 18, 2025
Trial Information
Current as of July 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating whether a combination of two medications, mirikizumab and tirzepatide, can help adults with ulcerative colitis (UC) and obesity or overweight to reduce their UC symptoms and lose at least 10% of their body weight. Participants will receive either the medications or a placebo (a harmless pill with no active ingredients) for a treatment period of 52 weeks, with the entire study lasting up to 61 weeks.
To be eligible for this trial, participants must have been diagnosed with UC for at least three months and have moderate to severe symptoms. They should also be classified as obese or overweight and have certain weight-related health issues, like high blood pressure or type 2 diabetes. It's important to note that this trial is not yet recruiting participants, but if you or someone you know fits these criteria, it could be an opportunity to help manage UC and related weight issues.
Gender
ALL
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.
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