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Clinical Trials in China / NCT07545759
Recruiting Phase 2

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

NCT07545759 · tracked via the Priya Life Science China tracker
Sponsor
Eli Lilly and Company
Phase
Phase 2
Started
2026-05-06
Last updated
2026-09-17

Condition(s) studied

Irritable Bowel SyndromeDiarrhea

Investigational drug(s) / intervention(s)

LY3537031 →Placebo

LY3537031: Administered SC

Placebo: Administered SC

Study 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 36 weeks.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (89)

FacilityCityRegionStatus
Del Sol Research Management - Mesa Mesa Arizona Recruiting
Smart Cures Clinical Research Anaheim California Recruiting
Om Research LLC Lancaster California Recruiting
United Medical Doctors - Los Alamitos Los Alamitos California Recruiting
Encore Medical Research Hollywood Florida Recruiting
Clinical Research of Osceola Kissimmee Florida Recruiting
Springfield Clinic - First Springfield Illinois Recruiting
Gastroenterology Health Partners New Albany Indiana Recruiting
Gastroenterology Health Partners Louisville Kentucky Recruiting
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center Wyoming Michigan Recruiting
Mayo Clinic in Rochester, Minnesota Rochester Minnesota Not Yet Recruiting
Ohio Gastroenterology Columbus Ohio Recruiting
University Gastroenterology Providence Rhode Island Recruiting
Biopharma Informatic, LLC McAllen Texas Recruiting
Southern Star Research Institute San Antonio Texas Recruiting
Sint Vincentius Ziekenhuis Antwerp Belgium Not Yet Recruiting
AZ Sint-Lucas Bruges Belgium Not Yet Recruiting
UZ Brussel Brussels Belgium Not Yet Recruiting
Antwerp University Hospital Edegem Belgium Not Yet Recruiting
AZ Maria Middelares Ghent Belgium Not Yet Recruiting
AZ Sint-Lucas Ghent Belgium Not Yet Recruiting
UZ Gent Ghent Belgium Not Yet Recruiting
UZ Leuven Leuven Belgium Not Yet Recruiting
Clinical Chc Montlégia Liège Belgium Not Yet Recruiting
AZ Delta vzw Roeselare Belgium Not Yet Recruiting
Bluewater Clinical Research Group Inc. Sarnia Canada Recruiting
Scarborough Center for Inflammatory Bowel Disease Scarborough Canada Recruiting
ClinSurge Research - LMC Scarborough / Malvern Medical Centre Scarborough Canada Recruiting
Stouffville Medical Research Institute Inc. Stouffville Canada Recruiting
Canadian Phase Onward Toronto Canada Recruiting
Binzhou Medical University Hospital Binzhou China Recruiting
Sichuan Provincial People's Hospital Chengdu China Recruiting
The First Affiliated Hospital, Sun Yat-sen University Guangzhou China Recruiting
Zhejiang Hospital of Traditioal Chinese Medicine Hangzhou China Recruiting
The Second Affiliated Hospital of University of South China Hengyang China Recruiting
Huizhou Central People's Hospital Huizhou China Recruiting
Huzhou Central Hospital Huzhou China Recruiting
Meihekou Central Hospital Meihekou China Recruiting
Quzhou People's Hospital Quzhou China Recruiting
Taian City Central Hospital Taian China Recruiting

+ 49 more sites — see the full list on the official registry below.

More Eli Lilly and Company trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07545759 on ClinicalTrials.gov ↗ ← All trials in China