What is brenipatide studying for Irritable Bowel Syndrome-Diarrhea (IBS-D)?

Brenipatide is being studied to evaluate its safety, side effects, and effectiveness in treating adults with IBS-D. Researchers want to understand how well participants tolerate the drug compared to a placebo and its impact on symptoms. This trial is sponsored by Eli Lilly and Company.

Who may be eligible for this Irritable Bowel Syndrome-Diarrhea clinical trial?

Adults aged 18 to 75 years with a diagnosis of IBS-D meeting specific stool consistency and abdominal pain criteria may be eligible. Participants must have had no major diet changes recently and no history of certain gastrointestinal disorders. Please review eligibility criteria for more details.

Is there any cost to participate in this Irritable Bowel Syndrome-Diarrhea clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 2

Age: 18Years - 75Years

All Genders

ID07545759

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

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)

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 to 75 years
Meet Rome IV criteria for IBS-D with more than 25% of bowel movements of Bristol Stool Form Scale Types 6 or 7 and less than 25% with Types 1 or 2
Have an average worst abdominal pain score of 3 or higher on a 0-to-10 scale during 14 consecutive days before randomization
Have at least 4 days per week with maximum Bristol Stool Form Scale of 5 or more, including at least 2 days with maximum of 6 during 14 consecutive days before randomization
No major changes in diet in the 4 weeks prior to screening

You will not qualify if you...

Diagnosis of IBS with constipation subtype, mixed IBS, or unclassified IBS by Rome IV criteria
History of inflammatory or immune-mediated gastrointestinal disorders
Known clinically significant gastric emptying abnormality

Research Team

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Physicians interested in becoming principal investigators please contact

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