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Mirikizumab and Tirzepatide for Ulcerative Colitis and Obesity/Overweight

This study is for adults aged 18 to 70 who have moderately to severely active ulcerative colitis (UC) and are also overweight or have obesity. Researchers are testing if taking two medications, mirikizumab and tirzepatide, at the same time is more effective than mirikizumab and a placebo (an inactive substance). The goal is to see if this combination can reduce or eliminate UC symptoms and help you lose at least 10% of your body weight. To join, you must have a confirmed diagnosis of UC for at least three months, with specific levels of disease activity confirmed by endoscopy. The study plans to enroll about 350 participants, but its current recruitment status is unclear.

Study design
This is an interventional study comparing two treatment groups. It plans to enroll about 350 participants.
What's involved
Your participation in this study will last up to 61 weeks, including 52 weeks of treatment.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured at Week 52, which is the end of the treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06937086

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

Recruiting
PHASE3Ages 18–70InterventionalTreatment
Eli Lilly and Company
~350 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:MirikizumabTirzepatidePlacebo

At a glance

Recruiting sites
174 of 188 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants Who Simultaneously Achieve Clinical Remission and at Least 10% Weight Reduction
Measured over Week 52

Conditions

Ulcerative Colitis
Obesity or Overweight

Explore related trials

ObesityOverweightUlcerative Colitis

Where it's being run

188 sites across 45 states
Mexico16
Brazil15
Poland12
France10
Spain10
Italy9
Turkey (Türkiye)9
Israel8

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Percentage of Participants Who Simultaneously Achieve Clinical Remission and at Least 10% Weight ReductionWeek 52

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