Current partner codePEPTIDESDE
NCT06937086·Phase 3·INTERVENTIONAL

Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study

Status

Recruiting

Phase

Phase 3

Enrollment

350

Locations

189

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

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

    Apr 2028

  4. Study completion

    Apr 2028

  5. Results posted

    Not reported

  6. Registry updated

    Jul 20, 2026

Outcomes

What the study measures.

Primary outcomes

Percentage of Participants Who Simultaneously Achieve Clinical Remission and at Least 10% Weight Reduction

Time frame · Week 52

Percentage of participants who simultaneously achieve clinical remission and at least 10% weight reduction.

Secondary outcomes

Percentage of Participants Who Achieve Clinical Remission

Time frame · Week 24 and Week 52

Percentage of participants who achieve clinical remission.

Percentage of Participants Who Achieve Endoscopic Response

Time frame · 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

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 Clinical Response

Time frame · Week 24 and Week 52

Percentage of participants who achieve clinical response.

Percentage of Participants Who Achieve Endoscopic Remission

Time frame · 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)

Time frame · 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

Time frame · Week 24 and Week 52

Percentage of participants achieving histologic remission.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
70 Years
Sex
ALL
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.

Study locations

189 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 Kingdom · 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

Icahn School of Medicine at Mount Sinai

New York, New York, United States

New York Gastroenterology Associates

New York, 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.