The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight. The maximum duration of this study is up to 61 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
290
Percentage of Participants Who Simultaneously Achieve Clinical Remission by Crohn's Disease Activity Index (CDAI), Endoscopic Remission, and at least 10% Weight Reduction
Percentage of participants who simultaneously achieve clinical remission by CDAI, endoscopic remission and at least 10% weight reduction.
Time frame: Week 52
Percentage of Participants Who Simultaneously Achieve Clinical Remission by CDAI and Endoscopic Remission
Percentage of participants who simultaneously achieve clinical remission by CDAI and endoscopic remission.
Time frame: Week 24, 52
Percentage of Participants Who Achieved Maintenance of Clinical Remission by CDAI
Percentage of participants who achieve maintenance of clinical remission by CDAI.
Time frame: Week 52
Percentage of Participants Who Achieved Maintenance of Endoscopic Remission
Percentage of participants who achieve maintenance of endoscopic remission.
Time frame: Week 52
Percentage of Participants Who Achieve Corticosteroid-free Clinical Remission by CDAI Among Participants Who Used Corticosteroids at Baseline
Percentage of participants who achieve corticosteroid-free clinical remission by CDAI among participants who used corticosteroids at baseline.
Time frame: Week 52
Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)
Change from baseline in inflammatory bowel disease questionnaire (IBDQ).
Time frame: Baseline, Week 52
Percentage of Participants Who Achieve at Least a 10% Reduction in Body Weight
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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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
RECRUITINGCalifornia 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 176 more locations
Percentage of participants who achieve at least a 10% reduction in body weight.
Time frame: Week 52