A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Key facts
- Where
- Anaheim, Columbus, Hollywood, Kissimmee, Lancaster, Los Alamitos, Louisville, McAllen, Mesa, New Albany, Providence, Rochester, San Antonio, Springfield, and Wyoming, United StatesSee the 15 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07545759, who can take part
Where in United States
- Smart Cures Clinical ResearchAnaheim, United StatesContact: Dennis Riff (principal investigator)Taking people
- Ohio GastroenterologyColumbus, United StatesContact: Ryan Gaible (principal investigator)Taking people
- Encore Medical ResearchHollywood, United StatesContact: Rodolfo Perez (principal investigator)Taking people
- Clinical Research of OsceolaKissimmee, United StatesContact: Basher Atiquzzaman (principal investigator)Taking people
- Om Research LLCLancaster, United StatesContact: Jatinder Pruthi (principal investigator)Taking people
- United Medical Doctors - Los AlamitosLos Alamitos, United StatesContact: Seyedehsan Navabi (principal investigator)Taking people
- Gastroenterology Health PartnersLouisville, United StatesContact: Michael Krease (principal investigator)Taking people
- Biopharma Informatic, LLCMcAllen, United StatesContact: Ralph Alhalel, MD (principal investigator)Taking people
- Del Sol Research Management - MesaMesa, United StatesContact: David Tessler (principal investigator)Taking people
- Gastroenterology Health PartnersNew Albany, United StatesContact: Jonathan Obert (principal investigator)Taking people
- University GastroenterologyProvidence, United StatesContact: Lisa Mueller (principal investigator)Taking people
- Mayo Clinic in Rochester, MinnesotaRochester, United StatesContact: Houssam Halawi (principal investigator)Not yet recruiting
- Southern Star Research InstituteSan Antonio, United StatesContact: Jeff Bullock (principal investigator)Taking people
- Springfield Clinic - FirstSpringfield, United StatesContact: Rajan Kochar (principal investigator)Taking people
- Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research CenterWyoming, United StatesContact: Allan Coates (principal investigator)Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07545759EU 2025-524973-17-00
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Brenipatide in the Treatment of Adult Participants With IBS-D
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.
Inclusion: Meet Rome IV criteria for IBS-D, which includes having greater than 25% of bowel movements with Bristol Stool Form Scale (BSFS) Types 6 or 7 and <25% of bowel movements with BSFS Types 1 or 2; Based on the daily eDiary collection during the screening period:; Have average of worst abdominal pain score of ≥3.0 on a 0-to-10-point scale during the 14 consecutive days prior to randomization; Have at least 4 days per week with a maximum BSFS ≥5 AND with at least 2 days of the 4 days per week with a maximum BSFS ≥6 during the 14 consecutive days prior to randomization; Have had no major changes in diet in the 4 weeks prior to screening.
Exclusion: Have a history of inflammatory or immune-mediated gastrointestinal disorders; Have a diagnosis of IBS with a subtype of constipation, mixed IBS, or unclassified IBS by the Rome IV criteria; Have a known clinically significant gastric emptying abnormality.