Health Trials

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

ConditionsUlcerative ColitisObesity or Overweight
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Mirikizumab

    Drug

    Administered IV

  • Mirikizumab

    Drug

    Administered SC

  • Tirzepatide

    Drug

    Administered SC

  • Placebo

    Drug

    Administered SC

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: Mirikizumab + TirzepatideExperimental treatment 2 interventions
Group B: Mirikizumab + PlaceboExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Percentage of Participants Who Simultaneously Achieve Clinical Remission and at Least 10% Weight Reduction

Percentage of participants who simultaneously achieve clinical remission and at least 10% weight reduction.

Time frame
Week 52

Secondary outcomes

1

Percentage of Participants Who Achieve Clinical Remission

Percentage of participants who achieve clinical remission.

Time frame
Week 24 and Week 52
2

Percentage of Participants Who Achieve Endoscopic Response

Percentage of participants who achieve endoscopic response.

Time frame
Week 24 and Week 52
3

Percentage of Participants Who Achieve Histologic-Endoscopic Mucosal Improvement Plus Absence of Neutrophils

Percentage of participants who achieve histologic-endoscopic mucosal improvement plus absence of neutrophils

Time frame
Week 24 and Week 52
4

Percentage of Participants Who Achieve Clinical Response

Percentage of participants who achieve clinical response.

Time frame
Week 24 and Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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