Crohn's Disease · Obesity or Overweight
Mirikizumab With Tirzepatide or Placebo for Crohn's Disease and Higher Weight
This randomized study is evaluating the efficacy and safety of mirikizumab with tirzepatide versus mirikizumab with placebo in adults with moderately to severely active Crohn's disease and obesity, or overweight with a weight-related condition.
Registry title: Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
35 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
In adults with moderately to severely active Crohn's disease and obesity or overweight, how do the efficacy and safety of mirikizumab plus tirzepatide compare with mirikizumab plus placebo?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 70 with confirmed Crohn's disease, including perianal fistulizing Crohn's disease.
- Participants must have moderately to severely active Crohn's disease, including a Crohn's Disease Activity Index score of at least 220 at baseline.
- Participants must have obesity, or overweight together with at least one of the listed weight-related health conditions.
- Participants must have had an inadequate response, loss of response, or intolerance to at least one protocol-specified conventional or advanced Crohn's disease therapy.
Participation overview
What participation may involve
Participation may involve intravenous and under-the-skin mirikizumab, plus under-the-skin tirzepatide or placebo. The registry states that the maximum study duration is up to 61 weeks. What participation may involve: - Receive mirikizumab first through a vein and then by injections under the skin. - Receive either tirzepatide or placebo by injections under the skin. - Have Crohn's disease activity evaluated with the Crohn's Disease Activity Index and endoscopic scoring. - Have body weight assessed and complete the Inflammatory Bowel Disease Questionnaire. The registry reports a maximum study duration of up to 61 weeks.
Study interventions
What participants may receive or do
- Mirikizumab: Participants in both study groups receive mirikizumab intravenously, meaning through a vein.
- Mirikizumab: After intravenous administration, participants in both study groups receive mirikizumab subcutaneously, meaning by an injection under the skin.
- Tirzepatide: Participants assigned to one study group receive tirzepatide by an injection under the skin alongside mirikizumab.
- Placebo: Participants assigned to the comparison group receive a placebo injection under the skin alongside mirikizumab.
Study design
How the comparison works
This Phase 3, parallel-group study randomly assigns participants to mirikizumab with tirzepatide or mirikizumab with placebo. Mirikizumab is open label, while tirzepatide and its matching placebo are blinded. 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, but mirikizumab is given open label. Both groups receive mirikizumab; the controlled comparison is between added tirzepatide and added placebo. The placebo is administered by an injection under the skin in the mirikizumab-plus-placebo group and is blinded to participants and investigators.
Reported activities
Procedures and tests
- Screening must confirm a Crohn's Disease Activity Index score of at least 220 at baseline.
- A centrally read Simple Endoscopic Score for Crohn's Disease is required within 21 days before the first study-treatment dose.
- For certain participants with Crohn's disease for at least eight years involving mainly or only the colon, screening requires documented negative colorectal dysplasia and cancer results from within the prior year.
- The study assesses clinical remission using the Crohn's Disease Activity Index.
- The study assesses endoscopic remission.
- Body weight is assessed to determine whether participants achieve at least a 10% reduction.
- Participants complete the Inflammatory Bowel Disease Questionnaire at baseline and 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
- A confirmed diagnosis of Crohn's disease or perianal fistulizing Crohn's disease is required.
- Participants must have a body mass index of at least 30, or a body mass index from 27 to under 30 plus at least one listed weight-related condition.
- Crohn's disease must be moderately to severely active, with a Crohn's Disease Activity Index score of at least 220 at baseline.
- A centrally reviewed endoscopy score must meet the stated threshold within 21 days before the first study-treatment dose.
- People with Crohn's disease for at least eight years involving mainly or only the colon must have documented negative colorectal dysplasia and cancer results within one year before baseline.
- Participants must have had an inadequate response, loss of response, or intolerance to at least one protocol-specified conventional or advanced Crohn's disease therapy.
Possible reasons someone may not be able to join
- A current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified, or primary sclerosing cholangitis excludes participation.
- Having more than two missing segments among the terminal ileum, right colon, transverse colon, left colon, and rectum excludes participation.
- A current or suspected abscess excludes participation.
- Having a stoma, ileoanal pouch, or ostomy excludes participation.
- Certain extensive bowel resections, short bowel syndrome, or intestinal or other abdominal surgery within three months before baseline exclude participation.
- Type 1 diabetes or insulin-treated type 2 diabetes excludes participation.
- Severe hypoglycemia or unrecognized low blood sugar within six months before screening excludes participation.
- A body-weight change greater than 5% during the past three months 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 or remote visits are required or how often visits occur.
- The study is randomized between tirzepatide and placebo groups, but the registry does not report the assignment ratio.
- Both groups receive mirikizumab, but the registry does not explain which other Crohn's disease or weight-related treatments may continue during the study.
- The registry does not report medication washout periods.
- The registry does not describe rescue treatment if Crohn's disease worsens.
- The registry requires a qualifying endoscopy score before treatment and measures endoscopic remission, but it does not provide the full endoscopy 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 does not report whether transportation, lodging, meals, or other travel support is available.
- The registry does not state whether any visits or assessments can be completed remotely.
- The registry does not describe access to study drugs after participation ends.
- The study is recruiting overall, but individual locations may have different recruitment statuses.
Before contacting the site
Questions for the study team
- What is the complete schedule of screening, treatment, endoscopy, and follow-up visits during the maximum 61-week study period?
- What is the chance of assignment to tirzepatide versus placebo, and when is the assignment revealed?
- Which current Crohn's disease, diabetes, blood-pressure, cholesterol, or weight medicines can continue, and are washouts required?
- How many endoscopies are required, when are they performed, and which are research-only rather than routine care?
- What happens if Crohn's disease worsens or significant side effects occur, including what rescue treatment is allowed?
- Which study-related costs are covered, is compensation offered, and is travel assistance available?
- Is the nearest listed site actively screening this study population, and can any visits be completed remotely?
Before changing care
Questions for your gastroenterologist
- How stable is my Crohn's disease now, and what concerns would you have about adding tirzepatide or placebo-controlled treatment to mirikizumab?
- Which of my current Crohn's disease and other medicines would need coordination with the research team, and how could changes affect disease control?
- What approved treatment alternatives should I compare with this study based on my disease activity, treatment history, and weight-related health conditions?
- How should my routine Crohn's disease monitoring and endoscopy care be coordinated with the study 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 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 design and administration
- Organization
- Eli Lilly and Company
- Organization class
- Industry
- Organization study ID
- 27281
- 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 a confirmed diagnosis of Crohn's disease (CD) or perianal fistulizing CDRegistry-derived · unreviewed
- 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: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 moderately to severely active CD defined by a CDAI score of at least 220 at baseline.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Demonstrated inadequate response, loss of response or intolerance to at least one protocol-specified conventional or advanced CD therapyRegistry-derived · unreviewed
Exclusion criteria (9)
- Have a current diagnosis of Ulcerative Colitis (UC), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis.Registry-derived · unreviewed
- Have more than 2 missing segments of the following 5 segments: terminal ileum, ·right colon, transverse colon, ·left colon, and rectum.Registry-derived · unreviewed
- Currently have or are suspected to have an abscess.Registry-derived · unreviewed
- Have a stoma, ileoanal pouch, or ostomy.Registry-derived · unreviewed
- 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.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 had more than 5% body weight change in the past 3 monthsRegistry-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 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 outcome
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.
Secondary outcome
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.
Secondary outcome
Percentage of Participants Who Achieved Maintenance of Endoscopic Remission
Time frame: Week 52
Percentage of participants who achieve maintenance of endoscopic remission.
Secondary outcome
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.
Secondary outcome
Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: Baseline, Week 52
Change from baseline in inflammatory bowel disease questionnaire (IBDQ).
Secondary outcome
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.
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
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
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 149 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
- May 2028
- Overall completion
- May 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.