Recruiting

Phase 2

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

Sponsor:

Eli Lilly and Company

Code:

NCT07545759

Conditions

Irritable Bowel Syndrome

Diarrhea

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

LY3537031

Placebo

Study Details

Brief 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.

Conditions

Irritable Bowel Syndrome

Diarrhea

Study ID

NCT07545759

Start date

May 6, 2026

Status verified date

Aug, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

531 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LY3537031

LY3537031 administered subcutaneously (SC)

placebo comparator: Placebo

Placebo administered SC

Interventions

LY3537031

Administered SC

Placebo

Administered SC

Primary outcome measure

Percentage of Participants Who Had a Daily Composite Response for at Least 50 Percent (%) of Days [ Time Frame: Week 9 to Week 16 ]

Central Contacts and Locations

Central contacts

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

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Del Sol Research Management - Mesa

Recruiting

Mesa, Arizona, United States, 85206

Contacts

520-257-3881

Principal Investigator:

David Tessler

Smart Cures Clinical Research

Recruiting

Anaheim, California, United States, 92806

Principal Investigator:

Dennis Riff

Om Research LLC

Recruiting

Lancaster, California, United States, 93534

Contacts

661-388-2239

Principal Investigator:

Jatinder Pruthi

United Medical Doctors - Los Alamitos

Recruiting

Los Alamitos, California, United States, 90720

Contacts

562-430-4449

Principal Investigator:

Seyedehsan Navabi

Encore Medical Research

Recruiting

Hollywood, Florida, United States, 33024

Contacts

954-400-1725

Principal Investigator:

Rodolfo Perez

Clinical Research of Osceola

Recruiting

Kissimmee, Florida, United States, 34741

Contacts

407-954-4016

Principal Investigator:

Basher Atiquzzaman

Springfield Clinic - First

Recruiting

Springfield, Illinois, United States, 62702

Contacts

217-528-7541

Principal Investigator:

Rajan Kochar

Gastroenterology Health Partners

Recruiting

New Albany, Indiana, United States, 47150

Contacts

812-206-1702

Principal Investigator:

Jonathan Obert

Gastroenterology Health Partners

Recruiting

Louisville, Kentucky, United States, 40218

Contacts

502-888-1988

Principal Investigator:

Michael Krease

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

Recruiting

Wyoming, Michigan, United States, 49519

Principal Investigator:

Allan Coates

Ohio Gastroenterology

Recruiting

Columbus, Ohio, United States, 43202

Contacts

614-754-5500

Principal Investigator:

Ryan Gaible

University Gastroenterology

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

401-421-8800

Principal Investigator:

Lisa Mueller

Biopharma Informatic, LLC

Recruiting

McAllen, Texas, United States, 78503

Contacts

281-944-3610

Principal Investigator:

Ralph Alhalel, MD

Southern Star Research Institute

Recruiting

San Antonio, Texas, United States, 78229

Contacts

210-581-2812

Principal Investigator:

Jeff Bullock

Bluewater Clinical Research Group Inc.

Recruiting

Sarnia, Canada, N7T 4X3

Contacts

1 (519) 344-6612

Principal Investigator:

John O'Mahony

Scarborough Center for Inflammatory Bowel Disease

Recruiting

Scarborough, Canada, M1B 3V4

Principal Investigator:

Jason Reinglas

ClinSurge Research - LMC Scarborough / Malvern Medical Centre

Recruiting

Scarborough, Canada, M1R 0B1

Principal Investigator:

Dale Connor

Stouffville Medical Research Institute Inc.

Recruiting

Stouffville, Canada, L4A 1H2

Contacts

(905) 640-3100

Principal Investigator:

Nima Mirtorabi

Canadian Phase Onward

Recruiting

Toronto, Canada, M3J 0K2

Principal Investigator:

Leslie Housefather

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-24.