RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Eli Lilly and Company • ClinicalTrials.gov ID: NCT07545772

Registry updated: 2026-10-08

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Description

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.

Interventions

LY3537031 (Drug)
Administered SC.
Placebo (Drug)
Administered SC.

Eligibility 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

Conditions

Irritable Bowel Syndrome Constipation

Locations

Del Sol Research Management - Mesa — Mesa, Arizona, United States
Smart Cures Clinical Research — Anaheim, California, United States
Om Research LLC — Lancaster, California, United States
United Medical Doctors - Los Alamitos — Los Alamitos, California, United States
Encore Medical Research — Hollywood, Florida, United States
Springfield Clinic - First — Springfield, Illinois, United States
Gastroenterology Health Partners — New Albany, Indiana, United States
Gastroenterology Health Partners — Louisville, Kentucky, United States
New York Gastroenterology Associates — New York, New York, United States
Ohio Gastroenterology — Columbus, Ohio, United States
University Gastroenterology — Providence, Rhode Island, United States
Biopharma Informatic, LLC — McAllen, Texas, United States
Southern Star Research Institute — San Antonio, Texas, United States
GI Alliance-Webster — Webster, Texas, United States
Sint Vincentius Ziekenhuis — Antwerp, Belgium
AZ Sint-Lucas — Bruges, Belgium
UZ Brussel — Brussels, Belgium
Antwerp University Hospital — Edegem, Belgium
AZ Maria Middelares — Ghent, Belgium
AZ Sint-Lucas — Ghent, Belgium
UZ Gent — Ghent, Belgium
UZ Leuven — Leuven, Belgium
Clinical Chc Montlégia — Liège, Belgium
AZ Delta vzw — Roeselare, Belgium
Bluewater Clinical Research Group Inc. — Sarnia, Canada
Scarborough Center for Inflammatory Bowel Disease — Scarborough, Canada
ClinSurge Research - LMC Scarborough / Malvern Medical Centre — Scarborough, Canada
Stouffville Medical Research Institute Inc. — Stouffville, Canada
Canadian Phase Onward — Toronto, Canada
Binzhou Medical University Hospital — Binzhou, China
Sichuan Provincial People's Hospital — Chengdu, China
The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, China
Zhejiang Hospital of Traditioal Chinese Medicine — Hangzhou, China
The Second Affiliated Hospital of University of South China — Hengyang, China
Huizhou Central People's Hospital — Huizhou, China
Huzhou Central Hospital — Huzhou, China
Meihekou Central Hospital — Meihekou, China
Quzhou People's Hospital — Quzhou, China
Taian City Central Hospital — Taian, China
Xianning Central Hospital — Xianning, China
Yichun People's Hospital — Yichun, China
Tokyo-Eki Center-building Clinic — Chūōku, Japan
Tokai University Hospital — Isehara, Japan
Aono Clinic — Kobe, Japan
Sapporo Odori Endoscope Clinic — Sapporo, Japan
Nishi-Shinjuku Kisaragi Clinic — Shinjuku-Ku, Japan
Scientia Investigacion Clinica Tj — Ciudad de Tijuana, Mexico
Centro de Investigación y Gastroenterología - S.C. — Mexico City, Mexico
Centro de Investigación Clinica Chapultepec — Mexico City, Mexico
Hospital Juarez de Mexico — Mexico City, Mexico
Kohler & Milstein Research S.A. De C.V. — Mérida, Mexico
CIMAB SA de CV — Torreón, Mexico
FAICIC S. de R.L. de C.V. — Veracruz, Mexico
Núcleo de Investigación Médica Sur de Guadalajara — Zapopan, Mexico
Hospital Universitari Vall d'Hebron — Barcelona, Spain
EAP Osona Sud - Alt Congost S.L.P — Centelles, Spain
Hospital Universitario Virgen Nieves — Granada, Spain
Hospital Clinico San Carlos — Madrid, Spain
Hospital Universitario Puerta de Hierro Majadahonda — Madrid, Spain
Hospital Costa del Sol — Marbella, Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca — Salamanca, Spain
Clínica Gaias - Santiago — Santiago de Compostela, Spain
Cheadle Community Hospital — Cheadle, United Kingdom
HMC Health Group - Meadows Centre for Health — Hounslow, United Kingdom
EMS Healthcare — Macclesfield, United Kingdom
Royal Victoria Infirmary — Newcastle upon Tyne, United Kingdom
Newquay Health Centre — Newquay, United Kingdom
Woodstock Bower Surgery — Rotherham, United Kingdom
Brockwood Medical Practice — Surrey, United Kingdom
King's Mill Hospital — Sutton in Ashfield, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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