Mirikizumab and Tirzepatide for Ulcerative Colitis and Obesity

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

Recruiting Phase 3 Interventional Study
Ulcerative Colitis Obesity or Overweight
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
350 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for

This trial is looking for adults with moderate to severe ulcerative colitis and obesity or overweight. Participants will receive a treatment for about a year to see if it helps with their symptoms and weight loss.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with ulcerative colitis for at least 3 months.
  • I have moderate to severe symptoms of ulcerative colitis.
  • I have obesity or overweight.
  • I have at least one weight-related health condition.
  • I have not responded well to other ulcerative colitis medications.

You may not be able to join if

  • I have Crohn's disease or another type of inflammatory bowel disease.
  • I have had or need bowel surgery.
  • I have certain severe colon issues.
  • I have Type 1 diabetes or insulin-treated Type 2 diabetes.
  • I have had severe low blood sugar issues recently.
  • I have gained or lost more than 5% of my weight in the last 3 months.
  • I have a current or recent active infection.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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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.

Trial Locations
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Eligibility 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 en…
Contacts

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

1-317-615-4559

LillyTrials@Lilly.com

CONTACT

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

CONTACT