Status:
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
Lead Sponsor:
Eli Lilly and Company
Conditions:
Ulcerative Colitis
Obesity or Overweight
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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 disa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06937086
Start Date
June 26 2025
End Date
April 1 2028
Last Update
December 18 2025
Active Locations (192)
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1
Digestive Health Specialists
Dothan, Alabama, United States, 36301
2
Smart Cures Clinical Research
Anaheim, California, United States, 92806
3
Cedars-Sinai Medical Center
Beverly Hills, California, United States, 90211
4
United Medical Doctors - Los Alamitos
Los Alamitos, California, United States, 90720