Recruiting NCT07545759
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LY3537031, Placebo.
- Who it may be relevant to
- Registry conditions: Irritable Bowel Syndrome, Diarrhea. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Belgium, Canada, China, Germany +5
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
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.
Interventions
- Drug LY3537031
Administered SC - Drug Placebo
Administered SC
Primary outcome measures
- Percentage of Participants Who Had a Daily Composite Response for at Least 50 Percent (%) of Days [Time frame: Week 9 to Week 16]
Secondary outcome measures (3)
- Percentage of Participants Who Had a Daily Abdominal Pain Response for at Least 50% of Days [Time frame: Week 9 to Week 16]
- Percentage of Participants Who Had Daily Stool Consistency Response for at Least 50% of Days [Time frame: Week 1 to Week 24]
- Percentage of Participants Who Had a Daily Composite Response [Time frame: Day 1 through Week 24]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 15 centers
- Del Sol Research Management - Mesa — Mesa
- Smart Cures Clinical Research — Anaheim
- Om Research LLC — Lancaster
- United Medical Doctors - Los Alamitos — Los Alamitos
- Encore Medical Research — Hollywood
- Clinical Research of Osceola — Kissimmee
- Springfield Clinic - First — Springfield
- Gastroenterology Health Partners — New Albany
- … and 7 more centers
China · 12 centers
- 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
- … and 4 more centers
Belgium · 10 centers
- 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
- … and 2 more centers
Mexico · 10 centers
- 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
- Centro de Investigación Clinica Chapultepec — Mexico City
- Hospital Juarez de Mexico — Mexico City
- Kohler & Milstein Research S.A. De C.V. — Mérida
- Clinical Research Institute S.C. — Tlalnepantla
- … and 2 more centers
Japan · 8 centers
- 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
Spain · 8 centers
- 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
- … and 1 more center
United Kingdom · 8 centers
Center list to be confirmed — check the primary protocol.
Poland · 7 centers
- 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
Germany · 6 centers
- FutureMeds GmbH — Berlin
- Studienzentrum MVZ Dachau — Dachau
- Klinische Forschung Hamburg — Hamburg
- Klinische Forschung Karlsruhe — Karlsruhe
- AmBeNet GmbH — Leipzig
- Dedicated Research Site FutureMeds — Offenbach
Canada · 5 centers
- 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
Identifiers
NCT: NCT07545759 · 27805 · J2S-MC-GZMS · 2025-524973-17-00