A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome, Constipation

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-Constipation (IBS-C). 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

NCT07545772

Run by

Eli Lilly and Company

People needed

342

Starts

2026-04-29

Expected to finish

2027-09-01

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…

• Meets Rome IV criteria for irritable bowel syndrome-constipation (IBS-C) including having more than 25% bowel movements with Bristol Stool Form Scale (BSFS) Types 1 or 2 and less than 25% of bowel movements with BSFS Types 6 or 7
• 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

You may not qualify if…

• Have a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea, 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

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

Full record on ClinicalTrials.gov

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