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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorEli Lilly and Company

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.

Eligibility criteria

Qualifiers

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)]

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Mirikizumab
  • Mirikizumab
  • Tirzepatide
  • Placebo

Treatment groups

350 Participants
are divided into 2 treatment groups

Locations

189
Austria
Medizinische Universität Graz8036, Graz Austria
Medizinische Universitaet Innsbruck6020, Innsbruck Austria
Medizinische Universität Wien1090, Vienna Austria
Belgium
AZORG Campus Aalst-Moorselbaan9300, Aalst Belgium

Sponsors and collaborators

Eli Lilly and Company

Lead sponsor