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-C

Status: Recruiting
Location: See all (70) 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-Constipation (IBS-C). 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:

• 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

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
Illinois
Springfield Clinic - First
RECRUITING
Springfield
Indiana
Gastroenterology Health Partners
RECRUITING
New Albany
Kentucky
Gastroenterology Health Partners
RECRUITING
Louisville
New York
New York Gastroenterology Associates
RECRUITING
New York
Ohio
Ohio Gastroenterology
RECRUITING
Columbus
Rhode Island
University Gastroenterology
RECRUITING
Providence
Texas
Biopharma Informatic, LLC
RECRUITING
Mcallen
Southern Star Research Institute
RECRUITING
San Antonio
GI Alliance-Webster
RECRUITING
Webster
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
Japan
Tokyo-Eki Center-building Clinic
RECRUITING
Chūōku
Tokai University Hospital
RECRUITING
Isehara
Aono Clinic
RECRUITING
Kobe
Sapporo Odori Endoscope Clinic
RECRUITING
Sapporo
Nishi-Shinjuku Kisaragi Clinic
RECRUITING
Shinjuku-ku
Mexico
Scientia Investigacion Clinica Tj
RECRUITING
Ciudad De Tijuana
Kohler & Milstein Research S.A. De C.V.
NOT_YET_RECRUITING
Mérida
Centro de Investigación Clinica Chapultepec
RECRUITING
Mexico City
Centro de Investigación y Gastroenterología - S.C.
RECRUITING
Mexico City
Hospital Juarez de Mexico
NOT_YET_RECRUITING
Mexico City
CIMAB SA de CV
NOT_YET_RECRUITING
Torreón
FAICIC S. de R.L. de C.V.
RECRUITING
Veracruz
Núcleo de Investigación Médica Sur de Guadalajara
RECRUITING
Zapopan
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
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: 2026-04-29
Estimated Completion Date: 2027-09
Participants
Target number of participants: 342
Treatments
Experimental: LY3537031
LY3537031 administered subcutaneously (SC).
Placebo_comparator: Placebo
Placebo administered SC.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov