A Phase 2 interventional study of Eltrekibart and Mirikizumab in Ulcerative Colitis and Ulcerative Colitis Chronic, sponsored by Eli Lilly and Company. Active, not recruiting at 207 sites in 21 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
The main purpose of this study is to determine the safety and efficacy of eltrekibart and mirikizumab in adult participants with moderately to severely active ulcerative colitis (UC).
The study will last approximately 4-5 years. Screening is required within 35 days prior to enrollment. For each participant, the total duration of the clinical trial will be about 69 weeks including screening.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 143 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.
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.
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive eltrekibart with placebo, eltrekibart or mirikizumab.
Drug: Eltrekibart · Drug: Mirikizumab · Drug: Placebo
Participants will receive mirikizumab and placebo or mirikizumab.
Drug: Mirikizumab · Drug: Placebo
Participants will receive eltrekibart and mirikizumab in combination or separately as monotherapy.
Drug: Eltrekibart · Drug: Mirikizumab
Participants will receive placebo or mirikizumab.
Drug: Mirikizumab · Drug: Placebo
Administered
Also known as: LY3041658
Administered
Also known as: LY3074828
Administered
Percentage of Participants Achieving Clinical Remission
Percentage of Participants Achieving Clinical Remission
Time frame: Week 12
Percentage of Participants Achieving Clinical Response
Percentage of Participants Achieving Clinical Response
Time frame: Week 12
Percentage of Participants Achieving Endoscopic Improvement
Percentage of Participants Achieving Endoscopic Improvement
Time frame: Week 12
Percentage of Participants Achieving Endoscopic Remission
Percentage of Participants Achieving Endoscopic Remission
Time frame: Week 12
Percentage of Participants Achieving Clinical Remission
Percentage of Participants Achieving Clinical Remission
Time frame: Week 52
Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement
Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement
Time frame: Week 12
Change From Baseline to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
Change From Baseline to Week 12 in IBDQ Total Score
Time frame: Baseline, Week 12
Pharmacokinetics (PK): Trough concentrations at Steady State (Ctrough ss) of Eltrekibart
PK: Ctrough ss of Eltrekibart
Time frame: Week 12
PK: Ctrough ss of Mirikizumab
PK: Ctrough ss of Mirikizumab
Time frame: Week 12
Showing the first 100 of 207 sites across 21 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 European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Ran from Oct 2024 to primary completion in Aug 2026, 21 months.
Of 109 industry-sponsored phase 2 interventional studies under Colitis, Ulcerative, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 35. This study's 21 months is below that.
Counting every sponsor, half of 153 studies reached it within 28 months; a quarter within 22 and three quarters within 43.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 30, 2026: primary completion Dec 2027 → Aug 2026 and completion Sep 2028 → Jul 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
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 ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Eltrekibart