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RecruitingPhase 2

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

Eli Lilly and Company · NCT07545772

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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
342
US sites recruiting
14
Study start
April 29, 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-Constipation (IBS-C). 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; Constipation

Eligibility criteria

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

Show full criteria

Inclusion Criteria

  • 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 Criteria

  • 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

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

  • 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

  • New York Gastroenterology Associates

    New York, NY 10075

    Site contact: 212-535-1845

  • 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

  • GI Alliance-Webster

    Webster, TX 77598

    Site contact: Sudhanshu Gogia

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… (NCT07545772) | Bored Studies