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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Eli Lilly and Company • ClinicalTrials.gov ID: NCT07545759

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-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.

Interventions

  • LY3537031 (Drug)
    Administered SC
  • Placebo (Drug)
    Administered SC

Eligibility 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

Conditions

Irritable Bowel Syndrome Diarrhea

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
  • Clinical Research of Osceola — Kissimmee, 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
  • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center — Wyoming, Michigan, United States
  • Mayo Clinic in Rochester, Minnesota — Rochester, Minnesota, 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
  • 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
  • FutureMeds GmbH — Berlin, Germany
  • Studienzentrum MVZ Dachau — Dachau, Germany
  • Pratia - Hamburg — Hamburg, Germany
  • Klinische Forschung Karlsruhe — Karlsruhe, Germany
  • AmBeNet GmbH — Leipzig, Germany
  • FutureMeds Offenbach — Offenbach, Germany
  • Tokyo-Eki Center-building Clinic — Chūōku, Japan
  • Sai Gastroenterology/Proctology Clinic — Fujiidera, Japan
  • Tokai University Hospital — Isehara, Japan
  • Aoyama Internal Medicine Clinic — Kobe, Japan
  • Aono Clinic — Kobe, Japan
  • Hattori Clinic - Kumamoto — Kumamoto, Japan
  • Sapporo Odori Endoscope Clinic — Sapporo, Japan
  • Nishi-Shinjuku Kisaragi Clinic — Shinjuku-Ku, Japan
  • Scientia Investigacion Clinica Tj — Ciudad de Tijuana, Mexico
  • Investigación Clínica Cuernavaca, S.C. — Cuernavaca, Mexico
  • Clinica de Investigacion en Reumatologia y Obesidad S. C. — Guadalajara, Mexico
  • Proactive CR México SA de CV — Irapuato, 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
  • Clinical Research Institute S.C. — Tlalnepantla, Mexico
  • CIMAB SA de CV — Torreón, Mexico
  • Núcleo de Investigación Médica Sur de Guadalajara — Zapopan, Mexico
  • Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero — Katowice, Poland
  • IRMED — Piotrkow Trybunalski, Poland
  • Twoja Przychodnia PCM — Poznan, Poland
  • Twoja Przychodnia SCM — Szczecin, Poland
  • WSD MEDI — Warsaw, Poland
  • Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś — Warsaw, Poland
  • ETG Zamość — Zamość, Poland
  • 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.

View Official Record