Obesity or Overweight, Ulcerative Colitis
Conditions
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 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.
Interventions
DRUGMirikizumab
Administered IV
DRUGTirzepatide
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Mirikizumab will be open label, tirzepatide and placebo to match will be blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Simultaneously Achieve Clinical Remission and at Least 10% Weight Reduction | Week 52 | Percentage of participants who simultaneously achieve clinical remission and at least 10% weight reduction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieve Clinical Remission | Week 24 and Week 52 | Percentage of participants who achieve clinical remission. |
| Percentage of Participants Who Achieve Endoscopic Response | Week 24 and Week 52 | Percentage of participants who achieve endoscopic response. |
| Percentage of Participants Who Achieve Histologic-Endoscopic Mucosal Improvement Plus Absence of Neutrophils | Week 24 and Week 52 | Percentage of participants who achieve histologic-endoscopic mucosal improvement plus absence of neutrophils |
| Percentage of Participants Who Achieve Clinical Response | Week 24 and Week 52 | Percentage of participants who achieve clinical response. |
| Percentage of Participants Who Achieve Endoscopic Remission | Week 24 and Week 52 | Percentage of participants who achieve endoscopic remission. |
| Percentage of Participants Who Achieve Bowel Movement Urgency Improvement Captured with Urgency Numeric Rating Scale (NRS) | Week 24 and Week 52 | The Urgency NRS is a patient-reported, single-item instrument that measures the severity for the urgency, sudden, or immediate need, to have a bowel movement in the past 24 hours using an 11 point NRS ranging from 0 "no urgency" to 10 "worst possible urgency" |
| Percentage of Participants Achieving Histologic Remission | Week 24 and Week 52 | Percentage of participants achieving histologic remission. |
Countries
Austria, Belgium, Brazil, Bulgaria, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Mexico, Netherlands, Poland, Puerto Rico, Romania, Slovakia, Spain, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed