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A Study of Brenipatide for Irritable Bowel Syndrome with Diarrhea (IBS-D)

This study is looking at a new medication called brenipatide (LY3537031) for people with Irritable Bowel Syndrome-Diarrhea (IBS-D). Researchers want to see how safe brenipatide is, what side effects it might cause, and how well it helps reduce symptoms compared to a placebo (an inactive substance). You might be able to join if you are 18 to 75 years old, have IBS-D based on specific criteria (Rome IV criteria), and experience certain levels of abdominal pain and diarrhea. The main goal is to see if brenipatide helps improve daily symptoms for at least 50% of the days between week 9 and week 16. The study's current status is unclear.

Study design
This is an interventional study comparing brenipatide to a placebo, with a planned enrollment of 531 participants. The phase of the study is not specified.
What's involved
The study will last approximately 35 weeks. The study drug, brenipatide or placebo, will be given as an injection under the skin (subcutaneously).
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured between Week 9 and Week 16, but the total study duration is approximately 35 weeks.

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NCT07545759

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

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Eli Lilly and Company
~531 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:LY3537031Placebo

At a glance

Recruiting sites
45 of 89 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants Who Had a Daily Composite Response for at Least 50 Percent (%) of Days
Measured over Week 9 to Week 16

Conditions

Irritable Bowel Syndrome
Diarrhea

Explore related trials

Irritable Bowel Syndrome

Where it's being run

89 sites across 20 states
China12
Belgium10
Mexico10
Japan8
Spain8
United Kingdom8
Poland7
Germany6

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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 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

What this trial measures

  • Percentage of Participants Who Had a Daily Composite Response for at Least 50 Percent (%) of DaysWeek 9 to Week 16