Accepting PatientsPhase 2 (Efficacy)NCT07545772

A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)

Irritable Bowel Syndrome, Constipation

Phase:Phase 2 (Efficacy)

Status:Accepting Patients

Age:18 - 75

Gender:All

Locations:70 sites

What This Study Is About

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.

Technical Description

Who Can Participate

You May Qualify If

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

You Cannot Join If

Have a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea, 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

View Full Eligibility Criteria

Full Criteria (from ClinicalTrials.gov)

Inclusion Criteria: * 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 Exclusion Criteria: * Have a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea, 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

Important: This is a summary. The final determination of eligibility will be made by the trial coordinator after reviewing your complete medical history.

Study Locations

Del Sol Research Management - Mesa — Mesa, Arizona

Smart Cures Clinical Research — Anaheim, California

Om Research LLC — Lancaster, California

Show all 70 locations

United Medical Doctors - Los Alamitos — Los Alamitos, California

Encore Medical Research — Hollywood, Florida

Springfield Clinic - First — Springfield, Illinois

Gastroenterology Health Partners — New Albany, Indiana

Gastroenterology Health Partners — Louisville, Kentucky

New York Gastroenterology Associates — New York, New York

Ohio Gastroenterology — Columbus, Ohio

University Gastroenterology — Providence, Rhode Island

Biopharma Informatic, LLC — McAllen, Texas

Southern Star Research Institute — San Antonio, Texas

GI Alliance-Webster — Webster, Texas

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

Clinical Chc Montlégia — Liège

AZ Delta vzw — Roeselare

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

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

Quzhou People's Hospital — Quzhou

Taian City Central Hospital — Taian

Xianning Central Hospital — Xianning

Yichun People's Hospital — Yichun

Tokyo-Eki Center-building Clinic — Chūōku

Tokai University Hospital — Isehara

Aono Clinic — Kobe

Sapporo Odori Endoscope Clinic — Sapporo

Nishi-Shinjuku Kisaragi Clinic — Shinjuku-Ku

Scientia Investigacion Clinica Tj — Ciudad de Tijuana

Centro de Investigación y Gastroenterología - S.C. — Mexico City

Centro de Investigación Clinica Chapultepec — Mexico City

Hospital Juarez de Mexico — Mexico City

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

CIMAB SA de CV — Torreón

FAICIC S. de R.L. de C.V. — Veracruz

Núcleo de Investigación Médica Sur de Guadalajara — Zapopan

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

Clínica Gaias - Santiago — Santiago de Compostela

Cheadle Community Hospital — Cheadle

HMC Health Group - Meadows Centre for Health — Hounslow

EMS Healthcare — Macclesfield

Royal Victoria Infirmary — Newcastle upon Tyne

Newquay Health Centre — Newquay

Woodstock Bower Surgery — Rotherham

Brockwood Medical Practice — Surrey

King's Mill Hospital — Sutton in Ashfield

Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

[email protected]

Phone

1-317-615-4559

Experimental Treatment

This trial is testing a new treatment. Results are not guaranteed. Talk to your doctor before applying.

Apply to This Trial

Your information will be sent to the study coordinator for review.