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Not yet recruiting Phase 2 NCT07545759

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

Phase 2 – studying effectiveness and dosage
Conditions: Irritable Bowel Syndrome Diarrhea

Sponsor: Eli Lilly and Company

trial.available_in: БГ
Overview
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 35 weeks.
Who can participate
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
Interventions
LY3537031
DRUG
Placebo
DRUG
Locations 88
Belgium (10)
Sint Vincentius Ziekenhuis
Antwerp
AZ Sint-Lucas
Bruges
UZ Brussel
Brussels
Antwerp University Hospital
Edegem
AZ Maria Middelares
Ghent
AZ Sint-Lucas
Ghent
UZ Gent
Ghent
UZ Leuven
Leuven
Clinical Chc Montlégia
Liège
AZ Delta vzw
Roeselare
Canada (5)
Bluewater Clinical Research Group Inc.
Sarnia
Scarborough Center for Inflammatory Bowel Disease
Scarborough
ClinSurge Research - LMC Scarborough / Malvern Medical Centre
Scarborough
Stouffville Medical Research Institute Inc.
Stouffville
Canadian Phase Onward
Toronto
China (12)
Binzhou Medical University Hospital
Binzhou
Sichuan Provincial People's Hospital
Chengdu
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou
Zhejiang Hospital of Traditioal Chinese Medicine
Hangzhou
The Second Affiliated Hospital of University of South China
Hengyang
Huizhou Central People's Hospital
Huizhou
Huzhou Central Hospital
Huzhou
Meihekou Central Hospital
Meihekou
Quzhou People's Hospital
Quzhou
Taian City Central Hospital
Taian
Xianning Central Hospital
Xianning
Yichun People's Hospital
Yichun
Germany (6)
FutureMeds GmbH
Berlin
Studienzentrum MVZ Dachau
Dachau
Klinische Forschung Hamburg
Hamburg
Klinische Forschung Karlsruhe
Karlsruhe
AmBeNet GmbH
Leipzig
Dedicated Research Site FutureMeds
Offenbach
Japan (8)
Tokyo-Eki Center-building Clinic
Chūōku
Sai Gastroenterology/Proctology Clinic
Fujiidera
Tokai University Hospital
Isehara
Aoyama Internal Medicine Clinic
Kobe
Aono Clinic
Kobe
Hattori Clinic - Kumamoto
Kumamoto
Sapporo Odori Endoscope Clinic
Sapporo
Nishi-Shinjuku Kisaragi Clinic
Shinjuku-Ku
Mexico (10)
Scientia Investigacion Clinica Tj
Ciudad de Tijuana
Investigación Clínica Cuernavaca, S.C.
Cuernavaca
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara
Proactive CR México SA de CV
Irapuato
Kohler & Milstein Research S.A. De C.V.
Mérida
Centro de Investigación Clinica Chapultepec
Mexico City
Hospital Juarez de Mexico
Mexico City
Clinical Research Institute S.C.
Tlalnepantla
CIMAB SA de CV
Torreón
Núcleo de Investigación Médica Sur de Guadalajara
Zapopan
Poland (7)
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
Katowice
IRMED
Piotrkow Trybunalski
Twoja Przychodnia PCM
Poznan
Twoja Przychodnia SCM
Szczecin
WSD MEDI
Warsaw
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw
ETG Zamość
Zamość
Spain (8)
Hospital Universitari Vall d'Hebron
Barcelona
EAP Osona Sud - Alt Congost S.L.P
Centelles
Hospital Universitario Virgen Nieves
Granada
Hospital Clinico San Carlos
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
Madrid
Hospital Costa del Sol
Marbella
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca
Clínica Gaias - Santiago
Santiago de Compostela
United Kingdom (8)
Cheadle Community Hospital
Cheadle
University Hospital of North Durham
Durham
HMC Health Group - Meadows Centre for Health
Hounslow
EMS Healthcare
Macclesfield
Newquay Health Centre
Newquay
Woodstock Bower Surgery
Rotherham
Brockwood Medical Practice
Surrey
King's Mill Hospital
Sutton in Ashfield
United States (14)
Smart Cures Clinical Research
Anaheim , California
Ohio Gastroenterology
Columbus , Ohio
Encore Medical Research
Hollywood , Florida
Clinical Research of Osceola
Kissimmee , Florida
Om Research LLC
Lancaster , California
United Medical Doctors - Los Alamitos
Los Alamitos , California
Gastroenterology Health Partners
Louisville , Kentucky
Biopharma Informatic, LLC
McAllen , Texas
Del Sol Research Management - Mesa
Mesa , Arizona
Gastroenterology Health Partners
New Albany , Indiana
University Gastroenterology
Providence , Rhode Island
Southern Star Research Institute
San Antonio , Texas
Springfield Clinic - First
Springfield , Illinois
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
Wyoming , Michigan
Technical details
Status
Not yet recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
01.04.2026
Completion date
01.11.2027
Registry ID
NCT07545759
Source
clinicaltrials.gov
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