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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
350
Administered IV
Administered SC
Administered SC
Administered SC
Digestive Health Specialists
Dothan, Alabama, United States
RECRUITINGSmart Cures Clinical Research
Anaheim, California, United States
RECRUITINGCedars-Sinai Medical Center
Beverly Hills, California, United States
NOT_YET_RECRUITINGUnited Medical Doctors - Los Alamitos
Los Alamitos, California, United States
Percentage of Participants Who Simultaneously Achieve Clinical Remission and at Least 10% Weight Reduction
Percentage of participants who simultaneously achieve clinical remission and at least 10% weight reduction.
Time frame: Week 52
Percentage of Participants Who Achieve Clinical Remission
Percentage of participants who achieve clinical remission.
Time frame: Week 24 and Week 52
Percentage of Participants Who Achieve Endoscopic Response
Percentage of participants who achieve endoscopic response.
Time frame: Week 24 and Week 52
Percentage of Participants Who Achieve Histologic-Endoscopic Mucosal Improvement Plus Absence of Neutrophils
Percentage of participants who achieve histologic-endoscopic mucosal improvement plus absence of neutrophils
Time frame: Week 24 and Week 52
Percentage of Participants Who Achieve Clinical Response
Percentage of participants who achieve clinical response.
Time frame: Week 24 and Week 52
Percentage of Participants Who Achieve Endoscopic Remission
Percentage of participants who achieve endoscopic remission.
Time frame: Week 24 and Week 52
Percentage of Participants Who Achieve Bowel Movement Urgency Improvement Captured with Urgency Numeric Rating Scale (NRS)
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"
Time frame: Week 24 and Week 52
Percentage of Participants Achieving Histologic Remission
Percentage of participants achieving histologic remission.
Time frame: Week 24 and Week 52
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
California Medical Research Associates
Northridge, California, United States
RECRUITINGResearch Associates of South Florida - Miami - Southwest 8th Street
Miami, Florida, United States
RECRUITINGGastro Health Research - Miami
Miami, Florida, United States
RECRUITINGOrlando Health
Orlando, Florida, United States
RECRUITINGDigestive and Liver Center of Florida
Orlando, Florida, United States
RECRUITINGGastro Health Research - Pensacola
Pensacola, Florida, United States
RECRUITING...and 182 more locations