Actively Recruiting
Phase 2 Study of Brenipatide LY3537031 Given Under the Skin to Treat Adults With Irritable Bowel Syndrome-Diarrhea IBS-D
Led by Eli Lilly and Company · Updated on 2026-08-06
531
Participants Needed
89
Research Sites
8 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, side effects, and effectiveness of brenipatide LY3537031 in adults with Irritable Bowel Syndrome-Diarrhea IBS-D. The study compares brenipatide administered under the skin with a placebo to understand its impact on this condition. This Phase 2 clinical trial involves participants aged 18 to 75 years. Participants will receive either the study drug brenipatide or a placebo through subcutaneous injections. The study follows a randomized, double-blind design where neither participants nor researchers know which treatment is given. Treatment and placebo administrations occur during the trial, which lasts approximately 35 weeks. During the study, participants will be monitored for how well they tolerate the drug and any side effects. Researchers will collect daily data on abdominal pain and stool consistency using an eDiary, focusing on responses between weeks 9 and 24. The primary measure is the percentage of participants achieving a daily composite response for at least half the days between weeks 9 and 16. Safety and efficacy outcomes are tracked throughout the trial period.
CONDITIONS
Brief Title
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Research Team
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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Physicians interested in becoming principal investigators please contact
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