Current partner codePEPTIDESDE
NCT06937099·Phase 3·INTERVENTIONAL

Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight

Status

Recruiting

Phase

Phase 3

Enrollment

290

Locations

186

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Mirikizumab

Administered IV

DRUG

Mirikizumab

Administered SC

DRUG

Tirzepatide

Administered SC

DRUG

Placebo

Administered SC

Timeline

From registration to results.

  1. First posted

    Apr 22, 2025

  2. Study start

    Jun 26, 2025

  3. Primary completion

    May 2028

  4. Study completion

    May 2028

  5. Results posted

    Not reported

  6. Registry updated

    Jul 7, 2026

Outcomes

What the study measures.

Primary 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.

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
70 Years
Sex
ALL
Healthy volunteers
No

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

186 registered sites.

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

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Tirzepatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.