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Looking for participantsPhase3

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

Sponsor: Eli Lilly and Company

NCT ID: NCT06937086

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Mirikizumab (drug), Mirikizumab (drug), Tirzepatide (drug), Placebo (drug)
How long the study runs
Study runs about 34 months (dates as stated)
About the drug or intervention
Mirikizumab — drug: Administered IV · Mirikizumab — drug: Administered SC · Tirzepatide — drug: Administered SC · Placebo — drug: Administered SC
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 70 Years
Who
All
Number of participants
350
Started
2025-06-26
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for ulcerative colitis
  • • Phase3 - 350 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 70 Years
  • • Diagnosed with ulcerative colitis

Where?

  • • Bristol - Southmead Hospital
  • • Dundee - Ninewells Hospital and Medical School
  • • Exeter - Royal Devon & Exeter Hospital
  • • London - Royal London Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Ulcerative ColitisObesity or Overweight

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 70 Years
  • Who can join: All genders

Biomarkers mentioned

documented negative

Treatment history

Treatments you must have had:

  • ✓ documented negative results for colorectal dysplasia and cancer

What the study is looking for

  • ✓Have had an established diagnosis of UC for ≥3 months before baseline which includes endoscopic evidence of UC and a...
  • ✓Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5 to 9 points and endoscopic...
  • ✓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...
  • ✓hypertension

Who cannot take part

  • ✗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.
See the full 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 Is This Study? (4 UK sites)

Southmead Hospital

Bristol BS10 5NB, United Kingdom

Recruiting
Site contact (verified)
Susanna MeadePrincipal Investigator

Ninewells Hospital and Medical School

Dundee DD1 9SY, United Kingdom

Recruiting
Site contact (verified)
Craig MowatPrincipal Investigator

Royal Devon & Exeter Hospital

Exeter EX2 5DW, United Kingdom

Recruiting
Site contact (verified)
TARIQ AHMADPrincipal Investigator

Royal London Hospital

London E1 2AJ, United Kingdom

Recruiting
Site contact (verified)
Gareth ParkesPrincipal Investigator

How to Get in Touch

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Sponsor contact

CONTACT

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

Sponsor contact

CONTACT

clinical_inquiry_hub@lilly.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10