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NCT07545759PHASE2Recruiting

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

Eli Lilly and Company

Start Date

5/6/2026

Completion Date

11/1/2027

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 Criteria

Age Range: 18 years to 75 years

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

DRUG

LY3537031

DRUG

Placebo

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Conditions

Irritable Bowel SyndromeDiarrhea

Locations

Del Sol Research Management - Mesa

Mesa, Arizona 85206

United States

Smart Cures Clinical Research

Anaheim, California 92806

United States

Om Research LLC

Lancaster, California 93534

United States

United Medical Doctors - Los Alamitos

Los Alamitos, California 90720

United States

Encore Medical Research

Hollywood, Florida 33024

United States

Clinical Research of Osceola

Kissimmee, Florida 34741

United States

Springfield Clinic - First

Springfield, Illinois 62702

United States

Gastroenterology Health Partners

New Albany, Indiana 47150

United States

Gastroenterology Health Partners

Louisville, Kentucky 40218

United States

Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center

Wyoming, Michigan 49519

United States

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota 55905

United States

Ohio Gastroenterology

Columbus, Ohio 43202

United States

University Gastroenterology

Providence, Rhode Island 02905

United States

Biopharma Informatic, LLC

McAllen, Texas 78503

United States

Southern Star Research Institute

San Antonio, Texas 78229

United States

Sint Vincentius Ziekenhuis

Antwerp, 2018

Belgium

AZ Sint-Lucas

Bruges, 8310

Belgium

UZ Brussel

Brussels, 1090

Belgium

Antwerp University Hospital

Edegem, 2650

Belgium

AZ Maria Middelares

Ghent, 9000

Belgium

AZ Sint-Lucas

Ghent, 9000

Belgium

UZ Gent

Ghent, 9000

Belgium

UZ Leuven

Leuven, 3000

Belgium

Clinical Chc Montlégia

Liège, 4000

Belgium

AZ Delta vzw

Roeselare, 8800

Belgium

Bluewater Clinical Research Group Inc.

Sarnia, N7T 4X3

Canada

Scarborough Center for Inflammatory Bowel Disease

Scarborough, M1B 3V4

Canada

ClinSurge Research - LMC Scarborough / Malvern Medical Centre

Scarborough, M1R 0B1

Canada

Stouffville Medical Research Institute Inc.

Stouffville, L4A 1H2

Canada

Canadian Phase Onward

Toronto, M3J 0K2

Canada

Binzhou Medical University Hospital

Binzhou, 256603

China

Sichuan Provincial People's Hospital

Chengdu, 610072

China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, 510080

China

Zhejiang Hospital of Traditioal Chinese Medicine

Hangzhou, 310006

China

The Second Affiliated Hospital of University of South China

Hengyang, 421200

China

Huizhou Central People's Hospital

Huizhou, 516001

China

Huzhou Central Hospital

Huzhou, 313000

China

Meihekou Central Hospital

Meihekou, 135000

China

Quzhou People's Hospital

Quzhou, 324000

China

Taian City Central Hospital

Taian, 271000

China

Xianning Central Hospital

Xianning, 437100

China

Yichun People's Hospital

Yichun, 336000

China

FutureMeds GmbH

Berlin, 10629

Germany

Studienzentrum MVZ Dachau

Dachau, 85221

Germany

Klinische Forschung Hamburg

Hamburg, 20253

Germany

Klinische Forschung Karlsruhe

Karlsruhe, 76137

Germany

AmBeNet GmbH

Leipzig, 04107

Germany

Dedicated Research Site FutureMeds

Offenbach, 63065

Germany

Tokyo-Eki Center-building Clinic

Chūōku, 103-0027

Japan

Sai Gastroenterology/Proctology Clinic

Fujiidera, 583-0027

Japan

Tokai University Hospital

Isehara, 259-1193

Japan

Aoyama Internal Medicine Clinic

Kobe, 650-0015

Japan

Aono Clinic

Kobe, 657-0841

Japan

Hattori Clinic - Kumamoto

Kumamoto, 860-0004

Japan

Sapporo Odori Endoscope Clinic

Sapporo, 060-0042

Japan

Nishi-Shinjuku Kisaragi Clinic

Shinjuku-Ku, 160-0023

Japan

Scientia Investigacion Clinica Tj

Ciudad de Tijuana, 22105

Mexico

Investigación Clínica Cuernavaca, S.C.

Cuernavaca, 62448

Mexico

Clinica de Investigacion en Reumatologia y Obesidad S. C.

Guadalajara, 44650

Mexico

Proactive CR México SA de CV

Irapuato, 36520

Mexico

Centro de Investigación Clinica Chapultepec

Mexico City, 04100

Mexico

Hospital Juarez de Mexico

Mexico City, 07760

Mexico

Kohler & Milstein Research S.A. De C.V.

Mérida, 97070

Mexico

Clinical Research Institute S.C.

Tlalnepantla, 54055

Mexico

CIMAB SA de CV

Torreón, 27000

Mexico

Núcleo de Investigación Médica Sur de Guadalajara

Zapopan, 45070

Mexico

Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero

Katowice, 40-600

Poland

IRMED

Piotrkow Trybunalski, 97-300

Poland

Twoja Przychodnia PCM

Poznan, 60-324

Poland

Twoja Przychodnia SCM

Szczecin, 71-434

Poland

WSD MEDI

Warsaw, 02-786

Poland

Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś

Warsaw, 04-501

Poland

ETG Zamość

Zamość, 22-400

Poland

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

EAP Osona Sud - Alt Congost S.L.P

Centelles, 08540

Spain

Hospital Universitario Virgen Nieves

Granada, 18014

Spain

Hospital Clinico San Carlos

Madrid, 28040

Spain

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, 28222

Spain

Hospital Costa del Sol

Marbella, 29603

Spain

Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

Salamanca, 37007

Spain

Clínica Gaias - Santiago

Santiago de Compostela, 15702

Spain

Cheadle Community Hospital

Cheadle, ST10 1NS

United Kingdom

HMC Health Group - Meadows Centre for Health

Hounslow, TW4 7NJ

United Kingdom

EMS Healthcare

Macclesfield, SK10 4TF

United Kingdom

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP

United Kingdom

Newquay Health Centre

Newquay, TR7 1RU

United Kingdom

Woodstock Bower Surgery

Rotherham, S61 1AH

United Kingdom

Brockwood Medical Practice

Surrey, RH3 7NJ

United Kingdom

King's Mill Hospital

Sutton in Ashfield, NG17 4JL

United Kingdom