DRUG
Mirikizumab
Administered IV
Status
Recruiting
Phase
Phase 3
Enrollment
290
Locations
186
Results
Not posted
Publications
0
Study summary
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.
Interventions
DRUG
Administered IV
DRUG
Administered SC
DRUG
Administered SC
DRUG
Administered SC
Timeline
First posted
Apr 22, 2025
Study start
Jun 26, 2025
Primary completion
May 2028
Study completion
May 2028
Results posted
Not reported
Registry updated
Jul 7, 2026
Outcomes
Percentage of Participants Who Simultaneously Achieve Clinical Remission by Crohn's Disease Activity Index (CDAI), Endoscopic Remission, and at least 10% Weight Reduction
Time frame · Week 52
Percentage of participants who simultaneously achieve clinical remission by CDAI, endoscopic remission and at least 10% weight reduction.
Percentage of Participants Who Simultaneously Achieve Clinical Remission by CDAI and Endoscopic Remission
Time frame · Week 24, 52
Percentage of participants who simultaneously achieve clinical remission by CDAI and endoscopic remission.
Percentage of Participants Who Achieved Maintenance of Clinical Remission by CDAI
Time frame · Week 52
Percentage of participants who achieve maintenance of clinical remission by CDAI.
Percentage of Participants Who Achieved Maintenance of Endoscopic Remission
Time frame · Week 52
Percentage of participants who achieve maintenance of endoscopic remission.
Percentage of Participants Who Achieve Corticosteroid-free Clinical Remission by CDAI Among Participants Who Used Corticosteroids at Baseline
Time frame · Week 52
Percentage of participants who achieve corticosteroid-free clinical remission by CDAI among participants who used corticosteroids at baseline.
Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame · Baseline, Week 52
Change from baseline in inflammatory bowel disease questionnaire (IBDQ).
Percentage of Participants Who Achieve at Least a 10% Reduction in Body Weight
Time frame · Week 52
Percentage of participants who achieve at least a 10% reduction in body weight.
Eligibility
Inclusion Criteria: * Have a confirmed diagnosis of Crohn's disease (CD) or perianal fistulizing CD * Have obesity body mass index 30 kilograms per meter squared (BMI ≥30 kg/m²), or overweight (BMI ≥27 kg/m2 to \<30 kg/m²) and in the presence of at least 1 weight-related comorbid conditions: * hypertension * Type 2 diabetes mellitus (T2DM) * dyslipidemia * obstructive sleep apnea, or * cardiovascular disease. * Have moderately to severely active CD defined by a CDAI score of at least 220 at baseline. * Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for patients with ileal-colonic or ≥4 for patients with isolated ileal disease within 21 days before the first dose of study treatment. * Participants with a history of CD for ≥8 years involving only or predominantly the colon must have documented negative results for colorectal dysplasia and cancer within 1 year prior to baseline. * Demonstrated inadequate response, loss of response or intolerance to at least one protocol-specified conventional or advanced CD therapy Exclusion Criteria: * Have a current diagnosis of Ulcerative Colitis (UC), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis. * Have more than 2 missing segments of the following 5 segments: terminal ileum, ·right colon, transverse colon, ·left colon, and rectum. * Currently have or are suspected to have an abscess. * Have a stoma, ileoanal pouch, or ostomy. * Have a history of more than 3 small bowel resections, total resection of small bowel greater than 100 centimeters (cm), diagnosis of short bowel syndrome, or any intestinal or non-intestinal intra-abdominal surgery within 3 months of baseline. * 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 had more than 5% body weight change in the past 3 months * Have a current or recent acute, active infection.
Study locations
Austria · Belgium · Brazil · Bulgaria · Canada · Czechia · Denmark · France · Germany · Greece · Hungary · Israel · Italy · Mexico · Netherlands · Poland · Puerto Rico · Romania · Slovakia · Spain · Turkey (Türkiye) · United States. Showing up to 24 locations stored in the fast local snapshot.
Digestive Health Specialists
Dothan, Alabama, United States
Smart Cures Clinical Research
Anaheim, California, United States
Cedars-Sinai Medical Center
Beverly Hills, California, United States
United Medical Doctors - Los Alamitos
Los Alamitos, California, United States
California Medical Research Associates
Northridge, California, United States
Research Associates of South Florida - Miami - Southwest 8th Street
Miami, Florida, United States
Gastro Health Research - Miami
Miami, Florida, United States
Orlando Health
Orlando, Florida, United States
Digestive and Liver Center of Florida
Orlando, Florida, United States
Gastro Health Research - Pensacola
Pensacola, Florida, United States
Precision Clinical Research
Sunrise, Florida, United States
Grand Teton Research Group
Idaho Falls, Idaho, United States
Rush University Medical Center
Chicago, Illinois, United States
Indiana University Health University Hospital
Indianapolis, Indiana, United States
Gastroenterology Health Partners
New Albany, Indiana, United States
Gastroenterology Health Partners
Louisville, Kentucky, United States
Care Access - New Iberia
New Iberia, Louisiana, United States
Louisiana Research Center
Shreveport, Louisiana, United States
Capital Digestive Care - Chevy Chase
Chevy Chase, Maryland, United States
Lucida Clinical Trials
New Bedford, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
New York Gastroenterology Associates
New York, New York, United States
Care Access - Yonkers
Yonkers, New York, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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