A Phase 3 interventional study of Mirikizumab and Mirikizumab in Crohn's Disease and Obesity or Overweight, sponsored by Eli Lilly and Company. Recruiting at 183 sites in 22 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 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.
The maximum duration of this study is up to 61 weeks.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's planned enrollment of 290 is above the median of 67 across 1,260 interventional studies indexed under Crohn Disease.
Browse Crohn Disease 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 obesity 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:
Exclusion Criteria:
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.
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.
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 by Crohn's Disease Activity Index (CDAI), Endoscopic Remission, and at least 10% Weight Reduction
Percentage of participants who simultaneously achieve clinical remission by CDAI, endoscopic remission and at least 10% weight reduction.
Time frame: Week 52
Percentage of Participants Who Simultaneously Achieve Clinical Remission by CDAI and Endoscopic Remission
Percentage of participants who simultaneously achieve clinical remission by CDAI and endoscopic remission.
Time frame: Week 24, 52
Percentage of Participants Who Achieved Maintenance of Clinical Remission by CDAI
Percentage of participants who achieve maintenance of clinical remission by CDAI.
Time frame: Week 52
Percentage of Participants Who Achieved Maintenance of Endoscopic Remission
Percentage of participants who achieve maintenance of endoscopic remission.
Time frame: Week 52
Percentage of Participants Who Achieve Corticosteroid-free Clinical Remission by CDAI Among Participants Who Used Corticosteroids at Baseline
Percentage of participants who achieve corticosteroid-free clinical remission by CDAI among participants who used corticosteroids at baseline.
Time frame: Week 52
Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)
Change from baseline in inflammatory bowel disease questionnaire (IBDQ).
Time frame: Baseline, Week 52
Percentage of Participants Who Achieve at Least a 10% Reduction in Body Weight
Percentage of participants who achieve at least a 10% reduction in body weight.
Time frame: Week 52
Showing the first 100 of 183 sites across 22 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