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RecruitingPhase 2

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

Eli Lilly and Company · NCT07545759

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
531
US sites recruiting
14
Study start
May 6, 2026
Record last updated
October 8, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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-Diarrhea (IBS-D). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo.

The study will last approximately 36 weeks.

Being studied: LY3537031; Placebo

Conditions: Irritable Bowel Syndrome; Diarrhea

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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 Criteria

  • 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

Recruiting US locations

  • Del Sol Research Management - Mesa

    Mesa, AZ 85206

    Site contact: 520-257-3881

  • Smart Cures Clinical Research

    Anaheim, CA 92806

    Site contact: Dennis Riff

  • Om Research LLC

    Lancaster, CA 93534

    Site contact: 661-388-2239

  • United Medical Doctors - Los Alamitos

    Los Alamitos, CA 90720

    Site contact: 562-430-4449

  • Encore Medical Research

    Hollywood, FL 33024

    Site contact: 954-400-1725

  • Clinical Research of Osceola

    Kissimmee, FL 34741

    Site contact: 407-954-4016

  • Springfield Clinic - First

    Springfield, IL 62702

    Site contact: 217-528-7541

  • Gastroenterology Health Partners

    New Albany, IN 47150

    Site contact: 812-206-1702

  • Gastroenterology Health Partners

    Louisville, KY 40218

    Site contact: 502-888-1988

  • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center

    Wyoming, MI 49519

    Site contact: Allan Coates

  • Ohio Gastroenterology

    Columbus, OH 43202

    Site contact: 614-754-5500

  • University Gastroenterology

    Providence, RI 02905

    Site contact: 401-421-8800

  • Biopharma Informatic, LLC

    McAllen, TX 78503

    Site contact: 281-944-3610

  • Southern Star Research Institute

    San Antonio, TX 78229

    Site contact: 210-581-2812

Study contacts (from the official record)

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · LillyTrials@Lilly.com
  • Physicians interested in becoming principal investigators please contact · clinical_inquiry_hub@lilly.com
A Study of Brenipatide (LY3537031) in Participants With Irritable… (NCT07545759) | Bored Studies