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A Study of Brenipatide for Irritable Bowel Syndrome with Constipation (IBS-C)

This study is looking at brenipatide (LY3537031) for people with Irritable Bowel Syndrome-Constipation (IBS-C). Researchers want to see how safe and effective brenipatide is, and what side effects might occur, compared to a placebo (an inactive substance). Brenipatide will be given as an injection under the skin. You may be able to join if you are 18 to 75 years old, have IBS-C based on specific criteria, and experience certain levels of abdominal pain. The study will measure success by looking at the percentage of participants who have a good weekly response to treatment over several weeks. The current status of this study is unclear.

Study design
This interventional study plans to enroll 342 participants. It will compare brenipatide (LY3537031) to a placebo.
What's involved
The study will last approximately 35 weeks. The study drug will be administered subcutaneously (under the skin).
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures response from Week 9 to Week 16.

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NCT07545772

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

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Eli Lilly and Company
~342 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:LY3537031Placebo

At a glance

Recruiting sites
47 of 70 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants with a Weekly Composite Clinical Response for at Least 50 Percent (%) of Weeks
Measured over Week 9 to 16

Conditions

Irritable Bowel Syndrome
Constipation

Explore related trials

Irritable Bowel Syndrome

Where it's being run

70 sites across 17 states
China12
Belgium10
Mexico8
Spain8
United Kingdom8
Canada5
Japan5
California3

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

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

Exclusion

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

What this trial measures

  • Percentage of Participants with a Weekly Composite Clinical Response for at Least 50 Percent (%) of WeeksWeek 9 to 16