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Taking people in IsraelPhase 3

Tests mirikizumab with or without tirzepatide in ulcerative colitis and excess weight

Tests mirikizumab alongside tirzepatide or placebo in adults with ulcerative colitis and overweight.

Key facts

Who runs it
Eli Lilly and Company
Where
Ashdod, Haifa, Holon, Jerusalem, Petah Tikva, Ramat Gan, Tel Aviv, and Tsrifin, IsraelSee the 8 sitesAlso in 22 other countries, 177 sites
Registry title
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
Status
Recruiting
Phase
Phase 3
People taking part
350 people, planned
Started
26 Jun 2025
Expected to end
Apr 2028
Type of study
Interventional, 2 groups
Treatments tested
  • Mirikizumab
  • Tirzepatide
  • Placebo
Record updated
4 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with moderately to severely active ulcerative colitis who also have obesity or overweight. It tests mirikizumab given together with tirzepatide.

Age
18 Years to 70 Years
Sex
All sexes can join.
Disease stage
Ulcerative colitis diagnosed at least 3 months before the start, with moderately to severely active disease (modified Mayo score 5 to 9 points and endoscopic subscore 2 to 3).
Earlier treatment
People must have had an inadequate response, loss of response or intolerance to at least 1 conventional medicine (oral corticosteroids, azathioprine or 6-mercaptopurine, or 5-aminosalicylates), and/or to advanced therapy such as a biologic or JAK inhibitor.
Biomarker or test result
Obesity (BMI 30 kg/m2 or more), or overweight (BMI 27 kg/m2 to under 30 kg/m2) with at least 1 weight-related condition such as hypertension, Type 2 Diabetes Mellitus, dyslipidemia, obstructive sleep apnea or cardiovascular disease.

Main reasons for not taking part

  • Crohn's disease, unclassified IBD or primary sclerosing cholangitis
  • Past or planned bowel resection or intestinal or intra-abdominal surgery
  • Type 1 Diabetes Mellitus or insulin-treated Type 2 Diabetes Mellitus
  • Severe hypoglycemia or hypoglycemia unawareness in the 6 months before screening
  • Body weight change of more than 5% in the 3 months before screening

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Have had or will need bowel resection or intestinal or intra-abdominal surgery
  • 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 diagnosis of:; Crohn's disease; inflammatory bowel disease (IBD) unclassified (formerly known as indeterminate colitis), or; primary sclerosing cholangitis
  • Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) or have insulin-treated T2DM
  • Have a current or recent acute, active infection
  • Have evidence of toxic megacolon, or stricture or stenosis within the colon that cannot be traversed by a sigmoidoscope or colonoscope

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 70 years old?

Where in Israel

Also in 22 other countries, 177 sites

  • Assuta Ashdod Medical CenterAshdod, IsraelContact: Adi Lahat-Zok (principal investigator)Taking people
  • Rambam Health Care CampusHaifa, IsraelContact: Roni Weisshof (principal investigator)Taking people
  • Edith Wolfson Medical CenterHolon, IsraelContact: Eran Israeli (principal investigator)Taking people
  • Shaare Zedek Medical CenterJerusalem, IsraelContact: Benjamin Koslowsky (principal investigator)Taking people
  • Rabin Medical CenterPetah Tikva, IsraelContact: Irit Avni-Biron (principal investigator)Taking people
  • Sheba medical centerRamat Gan, IsraelContact: Tal Engel (principal investigator)Taking people
  • Sourasky Medical CenterTel Aviv, IsraelContact: Nathaniel Cohen (principal investigator)Taking people
  • Yitzhak Shamir Medical CenterTsrifin, IsraelContact: EFRAT BROIDE (principal investigator)Taking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

Participation in this study will last up to 61 weeks, including 52 weeks of treatment.

The 2 groups in the trial

  • Mirikizumab + TirzepatideTreatment being tested

    Mirikizumab administered intravenously (IV) then Mirikizumab administered subcutaneously (SC). Tirzepatide administered SC.

    Treatment: Mirikizumab and Tirzepatide

  • Mirikizumab + PlaceboTreatment being tested

    Mirikizumab administered IV then Mirikizumab administered SC. Placebo administered SC.

    Treatment: Mirikizumab and Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests mirikizumab with or without tirzepatide in ulcerative colitis and excess weightGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06937086, who can take part
Record updated
4 November 2026