Irritable Bowel Syndrome (IBS) Clinical Trials

Find Irritable Bowel Syndrome (IBS) Clinical Trials Near You

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Brenipatide in the Treatment of Adult Participants With IBS-D

Status: Recruiting
Location: See all (89) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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-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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
Del Sol Research Management - Mesa
RECRUITING
Mesa
California
Smart Cures Clinical Research
RECRUITING
Anaheim
Om Research LLC
RECRUITING
Lancaster
United Medical Doctors - Los Alamitos
RECRUITING
Los Alamitos
Florida
Encore Medical Research
RECRUITING
Hollywood
Clinical Research of Osceola
RECRUITING
Kissimmee
Illinois
Springfield Clinic - First
RECRUITING
Springfield
Indiana
Gastroenterology Health Partners
RECRUITING
New Albany
Kentucky
Gastroenterology Health Partners
RECRUITING
Louisville
Michigan
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
RECRUITING
Wyoming
Minnesota
Mayo Clinic in Rochester, Minnesota
NOT_YET_RECRUITING
Rochester
Ohio
Ohio Gastroenterology
RECRUITING
Columbus
Rhode Island
University Gastroenterology
RECRUITING
Providence
Texas
Biopharma Informatic, LLC
RECRUITING
Mcallen
Southern Star Research Institute
RECRUITING
San Antonio
Other Locations
Belgium
Sint Vincentius Ziekenhuis
NOT_YET_RECRUITING
Antwerp
AZ Sint-Lucas
NOT_YET_RECRUITING
Bruges
UZ Brussel
NOT_YET_RECRUITING
Brussels
Antwerp University Hospital
NOT_YET_RECRUITING
Edegem
AZ Maria Middelares
NOT_YET_RECRUITING
Ghent
AZ Sint-Lucas
NOT_YET_RECRUITING
Ghent
UZ Gent
NOT_YET_RECRUITING
Ghent
UZ Leuven
NOT_YET_RECRUITING
Leuven
Clinical Chc Montlégia
NOT_YET_RECRUITING
Liège
AZ Delta vzw
NOT_YET_RECRUITING
Roeselare
Canada
Bluewater Clinical Research Group Inc.
RECRUITING
Sarnia
ClinSurge Research - LMC Scarborough / Malvern Medical Centre
RECRUITING
Scarborough
Scarborough Center for Inflammatory Bowel Disease
RECRUITING
Scarborough
Stouffville Medical Research Institute Inc.
RECRUITING
Stouffville
Canadian Phase Onward
RECRUITING
Toronto
China
Binzhou Medical University Hospital
RECRUITING
Binzhou
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
The First Affiliated Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Zhejiang Hospital of Traditioal Chinese Medicine
RECRUITING
Hangzhou
The Second Affiliated Hospital of University of South China
RECRUITING
Hengyang
Huizhou Central People's Hospital
RECRUITING
Huizhou
Huzhou Central Hospital
RECRUITING
Huzhou
Meihekou Central Hospital
RECRUITING
Meihekou
Quzhou People's Hospital
RECRUITING
Quzhou
Taian City Central Hospital
RECRUITING
Taian
Xianning Central Hospital
RECRUITING
Xianning
Yichun People's Hospital
RECRUITING
Yichun
Germany
FutureMeds GmbH
NOT_YET_RECRUITING
Berlin
Studienzentrum MVZ Dachau
NOT_YET_RECRUITING
Dachau
Klinische Forschung Hamburg
NOT_YET_RECRUITING
Hamburg
Klinische Forschung Karlsruhe
NOT_YET_RECRUITING
Karlsruhe
AmBeNet GmbH
NOT_YET_RECRUITING
Leipzig
Dedicated Research Site FutureMeds
NOT_YET_RECRUITING
Offenbach
Japan
Tokyo-Eki Center-building Clinic
RECRUITING
Chūōku
Sai Gastroenterology/Proctology Clinic
RECRUITING
Fujiidera
Tokai University Hospital
RECRUITING
Isehara
Aono Clinic
RECRUITING
Kobe
Aoyama Internal Medicine Clinic
RECRUITING
Kobe
Hattori Clinic - Kumamoto
RECRUITING
Kumamoto
Sapporo Odori Endoscope Clinic
RECRUITING
Sapporo
Nishi-Shinjuku Kisaragi Clinic
RECRUITING
Shinjuku-ku
Mexico
Scientia Investigacion Clinica Tj
NOT_YET_RECRUITING
Ciudad De Tijuana
Investigación Clínica Cuernavaca, S.C.
NOT_YET_RECRUITING
Cuernavaca
Clinica de Investigacion en Reumatologia y Obesidad S. C.
NOT_YET_RECRUITING
Guadalajara
Proactive CR México SA de CV
NOT_YET_RECRUITING
Irapuato
Kohler & Milstein Research S.A. De C.V.
NOT_YET_RECRUITING
Mérida
Centro de Investigación Clinica Chapultepec
NOT_YET_RECRUITING
Mexico City
Hospital Juarez de Mexico
NOT_YET_RECRUITING
Mexico City
Clinical Research Institute S.C.
NOT_YET_RECRUITING
Tlalnepantla
CIMAB SA de CV
NOT_YET_RECRUITING
Torreón
Núcleo de Investigación Médica Sur de Guadalajara
NOT_YET_RECRUITING
Zapopan
Poland
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
NOT_YET_RECRUITING
Katowice
IRMED
RECRUITING
Piotrkow Trybunalski
Twoja Przychodnia PCM
NOT_YET_RECRUITING
Poznan
Twoja Przychodnia SCM
NOT_YET_RECRUITING
Szczecin
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
NOT_YET_RECRUITING
Warsaw
WSD MEDI
NOT_YET_RECRUITING
Warsaw
ETG Zamość
RECRUITING
Zamość
Spain
Hospital Universitari Vall d'Hebron
NOT_YET_RECRUITING
Barcelona
EAP Osona Sud - Alt Congost S.L.P
RECRUITING
Centelles
Hospital Universitario Virgen Nieves
NOT_YET_RECRUITING
Granada
Hospital Clinico San Carlos
NOT_YET_RECRUITING
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
NOT_YET_RECRUITING
Madrid
Hospital Costa del Sol
NOT_YET_RECRUITING
Marbella
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
NOT_YET_RECRUITING
Salamanca
Clínica Gaias - Santiago
RECRUITING
Santiago De Compostela
United Kingdom
Cheadle Community Hospital
RECRUITING
Cheadle
HMC Health Group - Meadows Centre for Health
RECRUITING
Hounslow
EMS Healthcare
RECRUITING
Macclesfield
Royal Victoria Infirmary
NOT_YET_RECRUITING
Newcastle Upon Tyne
Newquay Health Centre
RECRUITING
Newquay
Woodstock Bower Surgery
RECRUITING
Rotherham
Brockwood Medical Practice
RECRUITING
Surrey
King's Mill Hospital
RECRUITING
Sutton In Ashfield
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2026-05-06
Estimated Completion Date: 2027-11
Participants
Target number of participants: 531
Treatments
Experimental: LY3537031
LY3537031 administered subcutaneously (SC)
Placebo_comparator: Placebo
Placebo administered SC
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov