COMMIT-UC

RecruitingPhase 3

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

A Phase 3b, Randomized, Multicenter, Controlled Study of Mirikizumab and Placebo or Mirikizumab Concomitantly Administered With Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight

Lead sponsor

Eli Lilly and Company

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

190

Recruiting sites

162

Enrollment

350

estimated

Study population

Gastrointestinal (gastroparesis / short bowel / pancreatitis), Obesity / overweight

Key I/E criterion

—

Primary endpoint

•Percentage of Participants Who Simultaneously Achieve Clinical Remission (≥10% weight-loss responders)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06937086

Org study ID27280

Secondary ID2024-520209-38-00

Secondary IDI6T-MC-AMCDEli Lilly and Company

Timeline

Milestones

Study first posted2025-04-22actual

Study start2025-06-26actual

Last update posted2026-05-12actual

Primary completion2028-04estimated (month precision)

Study completion2028-04estimated (month precision)

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Gastrointestinal (gastroparesis / short bowel / pancreatitis)Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Patient-reported / QoL

Other (unclassified)

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Percentage of Participants Who Achieve Bowel Movement Urgency Improvement Captured with Urgency Numeric Rating Scale (NRS)

Time frame:Week 24 and Week 52