A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome, Diarrhea

In brief

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 35 weeks.

Key facts

Study ID

NCT07545759

Run by

Eli Lilly and Company

People needed

531

Starts

2026-05-06

Expected to finish

2027-11-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Have a diagnosis of IBS with a subtype of constipation, mixed IBS, or unclassified IBS by the Rome IV criteria
• Have a history of inflammatory or immune-mediated gastrointestinal disorders
• Have a known clinically significant gastric emptying abnormality

Where it is running

• The Second Affiliated Hospital of University of South China — Hengyang, China (enrolling)
• Huzhou Central Hospital — Huzhou, China (enrolling)
• ClinSurge Research - LMC Scarborough / Malvern Medical Centre — Scarborough, Canada (enrolling)
• Zhejiang Hospital of Traditioal Chinese Medicine — Hangzhou, China (enrolling)
• Huizhou Central People's Hospital — Huizhou, China (enrolling)
• Springfield Clinic - First — Springfield, Illinois, United States (enrolling)
• Del Sol Research Management - Mesa — Mesa, Arizona, United States (enrolling)
• Scarborough Center for Inflammatory Bowel Disease — Scarborough, Canada (enrolling)
• Stouffville Medical Research Institute Inc. — Stouffville, Canada (enrolling)
• Binzhou Medical University Hospital — Binzhou, China (enrolling)
• Om Research LLC — Lancaster, California, United States (enrolling)
• University Gastroenterology — Providence, Rhode Island, United States (enrolling)
• Biopharma Informatic, LLC — McAllen, Texas, United States (enrolling)
• Southern Star Research Institute — San Antonio, Texas, United States (enrolling)
• Gastroenterology Health Partners — New Albany, Indiana, United States (enrolling)
• United Medical Doctors - Los Alamitos — Los Alamitos, California, United States (enrolling)
• Gastroenterology Health Partners — Louisville, Kentucky, United States (enrolling)
• Bluewater Clinical Research Group Inc. — Sarnia, Canada (enrolling)
• Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center — Wyoming, Michigan, United States (enrolling)
• Smart Cures Clinical Research — Anaheim, California, United States (enrolling)
• Encore Medical Research — Hollywood, Florida, United States (enrolling)
• Canadian Phase Onward — Toronto, Canada (enrolling)
• Ohio Gastroenterology — Columbus, Ohio, United States (enrolling)
• Clinical Research of Osceola — Kissimmee, Florida, United States (enrolling)
• Meihekou Central Hospital — Meihekou, China (enrolling)

Full record on ClinicalTrials.gov

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