A Phase 3 interventional study of Mirikizumab and Mirikizumab in Ulcerative Colitis and Obesity or Overweight, sponsored by Eli Lilly and Company. Recruiting at 186 sites in 23 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
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.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 350 is above the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Have overweight (BMI ≥27 kg/m2 to \<30 kg/m2) and in the presence of at least 1 of these weight-related comorbid conditions:
Exclusion Criteria:
Have a current diagnosis of:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mirikizumab administered intravenously (IV) then Mirikizumab administered subcutaneously (SC). Tirzepatide administered SC.
Drug: Mirikizumab · Drug: Tirzepatide
Mirikizumab administered IV then Mirikizumab administered SC. Placebo administered SC.
Drug: Mirikizumab · Drug: Placebo
Administered IV
Also known as: LY3074828
Administered SC
Also known as: LY3074828
Administered SC
Also known as: LY3298176
Administered SC
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
Percentage of Participants Who Achieve Clinical Remission
Percentage of participants who achieve clinical remission.
Time frame: Week 24 and Week 52
Percentage of Participants Who Achieve Endoscopic Response
Percentage of participants who achieve endoscopic response.
Time frame: Week 24 and Week 52
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
Percentage of Participants Who Achieve Clinical Response
Percentage of participants who achieve clinical response.
Time frame: Week 24 and Week 52
Percentage of Participants Who Achieve Endoscopic Remission
Percentage of participants who achieve endoscopic remission.
Time frame: Week 24 and Week 52
Percentage of Participants Who Achieve Bowel Movement Urgency Improvement Captured with Urgency Numeric Rating Scale (NRS)
The Urgency NRS is a patient-reported, single-item instrument that measures the severity for the urgency, sudden, or immediate need, to have a bowel movement in the past 24 hours using an 11 point NRS ranging from 0 "no urgency" to 10 "worst possible urgency"
Time frame: Week 24 and Week 52
Percentage of Participants Achieving Histologic Remission
Percentage of participants achieving histologic remission.
Time frame: Week 24 and Week 52
Showing the first 100 of 186 sites across 23 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
Data sharing details ↗ · vivli.org
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Tirzepatide