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Taking people in CanadaPhase 3

Tests mirikizumab with or without tirzepatide in adults with Crohn's disease and excess weight

Tests mirikizumab alone or with tirzepatide in adults with Crohn's and excess weight.

Key facts

Who runs it
Eli Lilly and Company
Where
Edmonton, London, Montreal, Ottawa, and Vancouver, CanadaSee the 7 sitesAlso in 21 other countries, 175 sites
Registry title
Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
Status
Recruiting
Phase
Phase 3
People taking part
290 people, planned
Started
26 Jun 2025
Expected to end
May 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 Crohn's disease who also have obesity or overweight.

Age
18 to 70 years
Sex
All sexes can join.
Disease stage
Moderately to severely active Crohn's disease, with a CDAI score of at least 220. A centrally read SES-CD score of at least 6 (ileal-colonic disease) or at least 4 (isolated ileal disease) is also needed.
Earlier treatment
Must have had an inadequate response, loss of response or intolerance to at least one protocol-specified conventional or advanced Crohn's disease therapy.
Biomarker or test result
BMI of at least 30 kg/m², or BMI of at least 27 to under 30 kg/m² with at least 1 weight-related condition (hypertension, type 2 diabetes, dyslipidemia, obstructive sleep apnea or cardiovascular disease).

Main reasons for not taking part

  • Ulcerative colitis, unclassified inflammatory bowel disease or primary sclerosing cholangitis
  • A stoma, ileoanal pouch or ostomy
  • Type 1 diabetes or insulin-treated type 2 diabetes
  • More than 5% body weight change in the past 3 months
  • Current or recent acute, active infection

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • Have a confirmed diagnosis of Crohn's disease (CD) or perianal fistulizing CD
  • Have obesity body mass index 30 kilograms per meter squared (BMI ≥30 kg/m²), or overweight (BMI ≥27 kg/m2 to <30 kg/m²) and in the presence of at least 1 weight-related comorbid conditions:; hypertension; Type 2 diabetes mellitus (T2DM); dyslipidemia; obstructive sleep apnea, or; cardiovascular disease
  • Have moderately to severely active CD defined by a CDAI score of at least 220 at baseline
  • Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for patients with ileal-colonic or ≥4 for patients with isolated ileal disease within 21 days before the first dose of study treatment
  • Participants with a history of CD for ≥8 years involving only or predominantly the colon must have documented negative results for colorectal dysplasia and cancer within 1 year prior to baseline
  • Demonstrated inadequate response, loss of response or intolerance to at least one protocol-specified conventional or advanced CD therapy

Who cannot take part

  • Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
  • Have a current diagnosis of Ulcerative Colitis (UC), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis
  • Have a history of more than 3 small bowel resections, total resection of small bowel greater than 100 centimeters (cm), diagnosis of short bowel syndrome, or any intestinal or non-intestinal intra-abdominal surgery within 3 months of baseline
  • Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) or have insulin-treated T2DM
  • Have a current or recent acute, active infection
  • Have more than 2 missing segments of the following 5 segments: terminal ileum, ·right colon, transverse colon, ·left colon, and rectum
  • Currently have or are suspected to have an abscess
  • Have a stoma, ileoanal pouch, or ostomy
  • Have had more than 5% body weight change in the past 3 months

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 Canada

Also in 21 other countries, 175 sites

  • Gastroenterology and internal medicine research instituteEdmonton, CanadaContact: Allen Lim (principal investigator)Taking people
  • London Digestive Disease InstituteLondon, CanadaContact: Vipul Jairath (principal investigator)Taking people
  • London Health Sciences CentreLondon, CanadaContact: Terry Ponich (principal investigator)Taking people
  • Clinique IMDMontreal, CanadaContact: Waqqas Afif (principal investigator)Taking people
  • The Ottawa Hospital - General CampusOttawa, CanadaContact: Jeffrey McCurdy (principal investigator)Not yet recruiting
  • (G.I.R.I.) GI Research Institute FoundationVancouver, CanadaContact: Greg Rosenfeld (principal investigator)Taking people
  • Vancouver General HospitalVancouver, CanadaContact: Sundeep Singh (principal investigator)Taking people

About the trial

What the trial wants to find out

The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight.

Read full original descriptionShow less

The maximum duration of this study is up to 61 weeks.

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 Crohn's Disease and Obesity or Overweight
Plain-language title
Tests mirikizumab with or without tirzepatide in adults with Crohn's disease 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 NCT06937099, who can take part
Record updated
4 November 2026