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Mirikizumab given at the same time as tirzepatide for adults with moderate-to-severe ulcerative colitis who are overweight or have obesity

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

Phase 3 Interventional Eli Lilly and Company · NCT06937086

This will test whether giving mirikizumab together with tirzepatide helps adults with moderate-to-severe ulcerative colitis who are overweight or obese reduce UC symptoms and lose at least 10% of their body weight.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment350 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionsustekinumab, tofacitinib, upadacitinib, mirikizumab
Locations190 sites (Dothan, Alabama and 189 other locations)
Trial IDNCT06937086 on ClinicalTrials.gov

What this trial studies

This Phase 3b trial compares treatment with mirikizumab plus tirzepatide to mirikizumab plus placebo in adults with moderately to severely active ulcerative colitis and overweight or obesity. Eligible participants have documented UC for at least 3 months, a modified Mayo score of 5–9 with endoscopic subscore 2–3, and meet body mass index criteria (BMI ≥30, or BMI ≥27 with a weight-related comorbidity). Participants are assigned to receive concurrent mirikizumab and either tirzepatide or placebo, with treatment lasting 52 weeks and total participation up to 61 weeks. Endoscopic confirmation is centrally reviewed and the co-primary outcomes include reduction or disappearance of UC symptoms and achieving at least 10% overall body weight loss.

Who should consider this trial

Good fit: Adults with moderately to severely active ulcerative colitis for ≥3 months (mMS 5–9 and endoscopic subscore 2–3) who are obese (BMI ≥30) or overweight (BMI ≥27) with at least one weight-related comorbidity and who meet the trial's prior-treatment criteria.

Not a fit: People with only mild ulcerative colitis, those who do not meet the study BMI/comorbidity requirements, or those with contraindications to either drug are unlikely to benefit from this specific combination approach.

Why it matters

Potential benefit: If successful, the combination could both improve UC symptoms and produce meaningful weight loss, potentially improving overall health and comorbid conditions.

How similar studies have performed: Both mirikizumab (for UC) and tirzepatide (for weight loss and glycemic control) have shown efficacy individually, but using them together for UC plus weight loss is a novel approach with limited prior combination data.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Dothan, Alabama and 189 other locations

+140 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ulcerative ColitisObesity or Overweight
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.