Actively Recruiting
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Led by Eli Lilly and Company · Updated on 2026-05-13
342
Participants Needed
1
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- During screening, have an average worst abdominal pain score of 3.0 or higher on a 0-to-10 scale over 14 consecutive days prior to randomization
You will not qualify if you...
- Diagnosis of irritable bowel syndrome with diarrhea subtype, mixed IBS, or unclassified IBS based on Rome IV criteria
- History of inflammatory or immune-mediated gastrointestinal disorders
- Known clinically significant gastric emptying abnormality
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Gastroenterology Health Partners Loc. 1
Louisville, Kentucky, United States, 40218
Actively Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
P
Physicians interested in becoming principal investigators please contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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