A Phase 2 interventional study of LY3537031 and Placebo in Irritable Bowel Syndrome and Diarrhea, sponsored by Eli Lilly and Company. Recruiting at 89 sites in 10 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated, what side effects may occur, and the safety and efficacy in participants with Irritable Bowel Syndrome-Diarrhea (IBS-D). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo.
The study will last approximately 36 weeks.
1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.
This study's planned enrollment of 531 is above the median of 70 across 896 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome 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.
Based on the daily eDiary collection during the screening period:
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LY3537031 administered subcutaneously (SC)
Drug: LY3537031
Placebo administered SC
Drug: Placebo
Administered SC
Also known as: Brenipatide
Administered SC
Percentage of Participants Who Had a Daily Composite Response for at Least 50 Percent (%) of Days
Time frame: Week 9 to Week 16
Percentage of Participants Who Had a Daily Abdominal Pain Response for at Least 50% of Days
Time frame: Week 9 to Week 16
Percentage of Participants Who Had Daily Stool Consistency Response for at Least 50% of Days
Time frame: Week 1 to Week 24
Percentage of Participants Who Had a Daily Composite Response
Time frame: Day 1 through Week 24
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 or 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
Started May 2026 (actual). Primary completion is estimated for Sep 2027, 16 months after the start.
Of 24 industry-sponsored phase 2 interventional studies under Irritable Bowel Syndrome, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 23. This study's planned 16 months is below that.
Counting every sponsor, half of 42 studies reached it within 21 months; a quarter within 14 and three quarters within 39.
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 ↗
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Studies of the drug tested here: Brenipatide