Obesity or Overweight · Ulcerative Colitis
Mirikizumab With Tirzepatide or Placebo for Ulcerative Colitis and Higher Weight
This randomized study compares mirikizumab with tirzepatide against mirikizumab with placebo in adults with moderately to severely active ulcerative colitis and obesity or qualifying overweight.
Registry title: 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
37 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–70 Years
- Treatment
- Mirikizumab or Tirzepatide
- Design
- Randomized · Double
- Central study contact
- Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559LillyTrials@Lilly.com
- Sponsor
- Eli Lilly and Company
Research question
Does adding tirzepatide to mirikizumab, rather than placebo, increase the proportion of participants who achieve both clinical remission and at least 10% weight reduction?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 70.
- Participants must have had ulcerative colitis for at least 3 months, supported by endoscopic and pathology evidence.
- Participants must have moderately to severely active ulcerative colitis within 21 days before baseline, confirmed through central review.
- Participants must have obesity, or overweight together with at least one listed weight-related health condition.
- Participants must have had an inadequate response, loss of response, or intolerance to at least one listed conventional or advanced ulcerative colitis therapy.
Participation overview
What participation may involve
Participation may last up to 61 weeks, including 52 weeks of treatment with mirikizumab plus either tirzepatide or matching placebo. What participation may involve: - Receive mirikizumab first through a vein and then by injections under the skin. - Receive either tirzepatide or matching placebo by injection under the skin. - Have ulcerative colitis symptoms and body-weight change assessed, including the combined primary assessment at Week 52. - Complete a bowel-movement urgency rating from 0 for no urgency to 10 for the worst possible urgency. Participation is reported to last up to 61 weeks, including 52 weeks of treatment.
Study interventions
What participants may receive or do
- Mirikizumab: Mirikizumab is administered intravenously, meaning through a vein, in both study groups.
- Mirikizumab: Mirikizumab is also administered subcutaneously, meaning as an injection under the skin, in both study groups.
- Tirzepatide: Tirzepatide is administered as an injection under the skin to participants assigned to the mirikizumab-plus-tirzepatide group.
- Placebo: A placebo matching tirzepatide is administered as an injection under the skin to participants in the comparison group.
Study design
How the comparison works
This Phase 3, parallel-group treatment study randomly assigns an estimated 350 participants to mirikizumab with tirzepatide or mirikizumab with placebo. Participants are randomly assigned to one of two parallel study groups; the registry does not report the assignment ratio. Participants and investigators are blinded to tirzepatide versus matching placebo, while mirikizumab is given openly. The comparison group receives mirikizumab plus placebo, allowing researchers to compare adding tirzepatide with not adding tirzepatide. The placebo matches tirzepatide and is injected under the skin; everyone receives mirikizumab.
Reported activities
Procedures and tests
- Intravenous administration of mirikizumab through a vein.
- Subcutaneous administration of mirikizumab by injection under the skin.
- Subcutaneous administration of tirzepatide or placebo by injection under the skin.
- Screening may involve confirming ulcerative colitis through prior endoscopic evidence and a pathology report.
- Disease activity must be documented with a modified Mayo score and a centrally reviewed endoscopic subscore within 21 days before baseline.
- For people with ulcerative colitis lasting at least 8 years, screening may require documentation from a surveillance colonoscopy completed within the prior year.
- Study assessments include endoscopic response, endoscopic remission, tissue-level remission, and combined tissue and endoscopic improvement at Weeks 24 and 52.
- Participants report bowel-movement urgency using an 11-point numeric rating scale.
- Body weight is assessed to determine whether participants achieve at least a 10% reduction by Week 52.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Ulcerative colitis must have been diagnosed at least 3 months before baseline, with endoscopic evidence and a supporting pathology report.
- Ulcerative colitis must be moderately to severely active, with a modified Mayo score of 5 to 9 and a centrally reviewed endoscopic subscore of 2 to 3 within 21 days before baseline.
- People with ulcerative colitis for at least 8 years who had a surveillance colonoscopy within the year before baseline must have documented negative results for colorectal dysplasia and cancer.
- A body mass index of at least 30 kg/m² meets the obesity requirement.
- A body mass index from 27 to under 30 kg/m² requires at least one listed condition: hypertension, type 2 diabetes, dyslipidemia, obstructive sleep apnea, or cardiovascular disease.
- At least one listed conventional or advanced ulcerative colitis treatment must have worked inadequately, stopped working, or been intolerable.
- Participants must be between ages 18 and 70.
Possible reasons someone may not be able to join
- A current diagnosis of Crohn's disease, unclassified inflammatory bowel disease, or primary sclerosing cholangitis excludes participation.
- People who have had or will need bowel resection or intestinal or intra-abdominal surgery are excluded.
- Toxic megacolon, or a colon narrowing that a sigmoidoscope or colonoscope cannot pass, excludes participation.
- Type 1 diabetes or type 2 diabetes treated with insulin excludes participation.
- Severe low blood sugar or lack of awareness of low blood sugar within the 6 months before screening excludes participation.
- A self-reported weight gain or loss greater than 5% during the 3 months before screening excludes participation.
- A current or recent acute, active infection excludes participation.
Important unknowns
What the record does not make clear
- The registry does not state how many in-person visits are required or how often they occur.
- The study has tirzepatide and placebo groups, but the registry does not report the randomization ratio or each participant's chance of receiving placebo.
- The registry does not explain which current ulcerative colitis or weight-related treatments may continue during the study.
- The registry does not provide medication washout requirements or timing.
- The registry does not describe rescue treatment if ulcerative colitis worsens.
- The registry reports endoscopic outcomes at Weeks 24 and 52 and requires a centrally reviewed endoscopic score before baseline, but it does not clearly state the complete procedure schedule.
- The registry does not state which study-related or routine-care costs are covered or billed to insurance.
- The registry does not report whether participants receive compensation.
- The registry lists study locations but does not describe reimbursement or support for travel, lodging, or meals.
- The registry does not say whether any visits or assessments can be completed remotely.
- The registry does not describe access to study treatments after participation ends.
- The study is recruiting overall, but listed locations have different statuses, so availability must be confirmed with a specific site.
Before contacting the site
Questions for the study team
- What is the randomization ratio, and what is my chance of receiving tirzepatide versus placebo?
- How many visits, injections, infusions, endoscopies, and biopsies are required, and when do they occur?
- Which current ulcerative colitis, diabetes, or weight-related medicines can continue, and are washout periods required?
- What happens if ulcerative colitis symptoms worsen or significant side effects occur during the study?
- Which study-related costs are covered, and is compensation or travel support available?
- Can any visits be completed remotely or through my local gastroenterologist?
- Is the site nearest me actively accepting participants, and are enrollment slots still available?
- What treatment or follow-up is available after the 52-week treatment period?
Before changing care
Questions for your gastroenterologist
- How stable is my ulcerative colitis now, and what are the risks of changing or pausing my current treatment?
- What approved treatment alternatives should I consider alongside learning more about this study?
- How might my diabetes status, weight history, infection history, or other health conditions affect the risks of the study treatments?
- Would the required endoscopic and tissue assessments be appropriate in my clinical situation?
- How should my regular gastroenterology care be coordinated with the research team if I pursue screening?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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 design and administration
- Organization
- Eli Lilly and Company
- Organization class
- Industry
- Organization study ID
- 27280
- Lead sponsor
- Eli Lilly and Company
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Double
- Who is masked
- Participant, Investigator
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Mirikizumab + Tirzepatide
Mirikizumab administered intravenously (IV) then Mirikizumab administered subcutaneously (SC). Tirzepatide administered SC.
Interventions: Drug: Mirikizumab, Drug: Tirzepatide
Experimental
Mirikizumab + Placebo
Mirikizumab administered IV then Mirikizumab administered SC. Placebo administered SC.
Interventions: Drug: Mirikizumab, Drug: Placebo
Interventions
Drug
Mirikizumab
Administered IV
Drug
Mirikizumab
Administered SC
Drug
Tirzepatide
Administered SC
Drug
Placebo
Administered SC
Eligibility
18 Years–70 Years
All
Not accepted
Inclusion criteria (11)
- 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.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Have obesity, \[body mass index (BMI) 30 kilograms per meter squared (kg/m2)\]Registry-derived · unreviewed
- Have overweight (BMI ≥27 kg/m2 to \<30 kg/m2) and in the presence of at least 1 of these weight-related comorbid conditions:Registry-derived · unreviewed
- hypertensionRegistry-derived · unreviewed
- Type 2 Diabetes Mellitus (T2DM)Registry-derived · unreviewed
- dyslipidemiaRegistry-derived · unreviewed
- obstructive sleep apnea, orRegistry-derived · unreviewed
- cardiovascular disease.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
Exclusion criteria (10)
- Have a current diagnosis of:Registry-derived · unreviewed
- Crohn's diseaseRegistry-derived · unreviewed
- inflammatory bowel disease (IBD) unclassified (formerly known as indeterminate colitis), orRegistry-derived · unreviewed
- primary sclerosing cholangitis.Registry-derived · unreviewed
- Have had or will need bowel resection or intestinal or intra-abdominal surgery.Registry-derived · unreviewed
- Have evidence of toxic megacolon, or stricture or stenosis within the colon that cannot be traversed by a sigmoidoscope or colonoscope.Registry-derived · unreviewed
- Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) or have insulin-treated T2DM.Registry-derived · unreviewed
- Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening.Registry-derived · unreviewed
- Have a self-reported change in body weight greater than 5% (gain or reduction) within 3 months prior to screening.Registry-derived · unreviewed
- Have a current or recent acute, active infection.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
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 outcome
Percentage of Participants Who Achieve Clinical Remission
Time frame: Week 24 and Week 52
Percentage of participants who achieve clinical remission.
Secondary outcome
Percentage of Participants Who Achieve Endoscopic Response
Time frame: Week 24 and Week 52
Percentage of participants who achieve endoscopic response.
Secondary outcome
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
Secondary outcome
Percentage of Participants Who Achieve Clinical Response
Time frame: Week 24 and Week 52
Percentage of participants who achieve clinical response.
Secondary outcome
Percentage of Participants Who Achieve Endoscopic Remission
Time frame: Week 24 and Week 52
Percentage of participants who achieve endoscopic remission.
Secondary outcome
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"
Secondary outcome
Percentage of Participants Achieving Histologic Remission
Time frame: Week 24 and Week 52
Percentage of participants achieving histologic remission.
Recruiting locations in the United States
Smart Cures Clinical Research
RecruitingAnaheim, California, 92806, United States
Dennis Riff
Cedars-Sinai Medical Center
RecruitingBeverly Hills, California, 90211, United States
Andres Yarur
United Medical Doctors - Los Alamitos
RecruitingLos Alamitos, California, 90720, United States
Seyedehsan Navabi
California Medical Research Associates
RecruitingNorthridge, California, 91324, United States
Calin Arimie
Gastro Health Research - Miami
RecruitingMiami, Florida, 33176, United States
Lukasz Kwapisz
Research Associates of South Florida - Miami - Southwest 8th Street
RecruitingMiami, Florida, 33134, United States
Alexander Veloso
Digestive and Liver Center of Florida
RecruitingOrlando, Florida, 32825, United States
Harinath Sheela
Orlando Health
RecruitingOrlando, Florida, 32806, United States
Udayakumar Navaneethan
Gastro Health Research - Pensacola
RecruitingPensacola, Florida, 32504, United States
Frederic Newman
Precision Clinical Research
RecruitingSunrise, Florida, 33351, United States
Jeffrey Schneider
Grand Teton Research Group
RecruitingIdaho Falls, Idaho, 83404, United States
Todd Williams
Rush University Medical Center
RecruitingChicago, Illinois, 60612, United States
Atsushi Sakuraba
Indiana University Health University Hospital
RecruitingIndianapolis, Indiana, 46202, United States
Monika Fischer
Gastroenterology Health Partners
RecruitingNew Albany, Indiana, 47150, United States
Robert Luckett
Gastroenterology Health Partners
RecruitingLouisville, Kentucky, 40218, United States
Michael Krease
Louisiana Research Center
RecruitingShreveport, Louisiana, 71105, United States
John Provenza
Capital Digestive Care - Chevy Chase
RecruitingChevy Chase, Maryland, 20815, United States
Erica Cohen
Lucida Clinical Trials
RecruitingNew Bedford, Massachusetts, 02740, United States
Paul Sepe
Washington University School of Medicine
RecruitingSt Louis, Missouri, 63110, United States
Parakkal Deepak
Dartmouth-Hitchcock Medical Center
RecruitingLebanon, New Hampshire, 03756, United States
Corey Siegel
Icahn School of Medicine at Mount Sinai
RecruitingNew York, New York, 10029, United States
Stephanie Gold
New York Gastroenterology Associates
RecruitingNew York, New York, 10075, United States
Arthur Kornbluth
Care Access - Yonkers
RecruitingYonkers, New York, 10701, United States
Peter Wayne
Coastal Research Institute - Fayetteville
RecruitingFayetteville, North Carolina, 28304, United States
John Poulos
Gastro Intestinal Research Institute of Northern Ohio, LLC
RecruitingWestlake, Ohio, 44145, United States
Mousab Tabbaa
Thomas Jefferson University - Medicine/GI and Hepatology
RecruitingPhiladelphia, Pennsylvania, 19107, United States
Priya Sehgal
University Gastroenterology
RecruitingProvidence, Rhode Island, 02905, United States
Lisa Mueller
Gastroenterology Associates - Patewood
RecruitingGreenville, South Carolina, 29607, United States
Matthew Barnes
Gastroenterology Center Of The Midsouth
RecruitingCordova, Tennessee, 38018, United States
Ziad Younes
Gastroenterology Research of San Antonio
RecruitingSan Antonio, Texas, 78229, United States
Charles Randall
Southern Star Research Institute
RecruitingSan Antonio, Texas, 78229, United States
Jeff Bullock
Gastroenterology Consultants of Southwest Virginia
RecruitingRoanoke, Virginia, 24014, United States
Nirish Shah
Washington Gastroenterology - Tacoma
RecruitingTacoma, Washington, 98405, United States
William Holderman
Wisconsin Center for Advanced Research
RecruitingMilwaukee, Wisconsin, 53215, United States
Chetan Mittal
This study also lists 151 locations outside the United States. They are not shown here.
Central study contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
Physicians interested in becoming principal investigators please contact
Contact
Registry dates
- First posted
- Apr 22, 2025
- Primary completion
- Apr 2028
- Overall completion
- Apr 2028
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.