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

NCT07545772 · tracked via the Priya Life Science USA tracker

Sponsor

Eli Lilly and Company

Phase

Phase 2

Started

2026-04-29

Last updated

2026-09-17

Condition(s) studied

Irritable Bowel SyndromeConstipation

Investigational drug(s) / intervention(s)

LY3537031Placebo

LY3537031: Administered SC.

Placebo: Administered SC.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (70)

Facility	City	Region	Status
Del Sol Research Management - Mesa	Mesa	Arizona	Recruiting
Smart Cures Clinical Research	Anaheim	California	Recruiting
Om Research LLC	Lancaster	California	Recruiting
United Medical Doctors - Los Alamitos	Los Alamitos	California	Recruiting
Encore Medical Research	Hollywood	Florida	Recruiting
Springfield Clinic - First	Springfield	Illinois	Recruiting
Gastroenterology Health Partners	New Albany	Indiana	Recruiting
Gastroenterology Health Partners	Louisville	Kentucky	Recruiting
New York Gastroenterology Associates	New York	New York	Recruiting
Ohio Gastroenterology	Columbus	Ohio	Recruiting
University Gastroenterology	Providence	Rhode Island	Recruiting
Biopharma Informatic, LLC	McAllen	Texas	Recruiting
Southern Star Research Institute	San Antonio	Texas	Recruiting
GI Alliance-Webster	Webster	Texas	Recruiting
Sint Vincentius Ziekenhuis	Antwerp	Belgium	Not Yet Recruiting
AZ Sint-Lucas	Bruges	Belgium	Not Yet Recruiting
UZ Brussel	Brussels	Belgium	Not Yet Recruiting
Antwerp University Hospital	Edegem	Belgium	Not Yet Recruiting
AZ Maria Middelares	Ghent	Belgium	Not Yet Recruiting
AZ Sint-Lucas	Ghent	Belgium	Not Yet Recruiting
UZ Gent	Ghent	Belgium	Not Yet Recruiting
UZ Leuven	Leuven	Belgium	Not Yet Recruiting
Clinical Chc Montlégia	Liège	Belgium	Not Yet Recruiting
AZ Delta vzw	Roeselare	Belgium	Not Yet Recruiting
Bluewater Clinical Research Group Inc.	Sarnia	Canada	Recruiting
Scarborough Center for Inflammatory Bowel Disease	Scarborough	Canada	Recruiting
ClinSurge Research - LMC Scarborough / Malvern Medical Centre	Scarborough	Canada	Recruiting
Stouffville Medical Research Institute Inc.	Stouffville	Canada	Recruiting
Canadian Phase Onward	Toronto	Canada	Recruiting
Binzhou Medical University Hospital	Binzhou	China	Recruiting
Sichuan Provincial People's Hospital	Chengdu	China	Recruiting
The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	China	Recruiting
Zhejiang Hospital of Traditioal Chinese Medicine	Hangzhou	China	Recruiting
The Second Affiliated Hospital of University of South China	Hengyang	China	Recruiting
Huizhou Central People's Hospital	Huizhou	China	Recruiting
Huzhou Central Hospital	Huzhou	China	Recruiting
Meihekou Central Hospital	Meihekou	China	Recruiting
Quzhou People's Hospital	Quzhou	China	Recruiting
Taian City Central Hospital	Taian	China	Recruiting
Xianning Central Hospital	Xianning	China	Recruiting

+ 30 more sites — see the full list on the official registry below.

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Other trials for the same condition

IBS Skin Patch Test Food Allergy Study Recruiting

A Study to Assess Maternal and Fetal Outcomes After Taking Prucalopride During Pregnancy Active, not recruiting

Radicle GI HealthTM VNB: A Study Assessing the Impact of Health and Wellness Products on Constipation and Related Health Outcomes Recruiting

Assessment of Psilocybin (TRP-8802) in Concert With Psychotherapy in Patients With Irritable Bowel Syndrome (IBS) Active, not recruiting

Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07545772 on ClinicalTrials.gov ↗ ← All trials in the USA