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

May 11, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

531

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Belgium
      • Antwerp, Belgium, 2018
        • Not yet recruiting
        • Sint Vincentius Ziekenhuis
        • Principal Investigator:
          • Sara Nullens
        • Contact:
          • Phone Number: 003232852814
      • Bruges, Belgium, 8310
        • Not yet recruiting
        • AZ Sint-Lucas
        • Principal Investigator:
          • Joris Arts
        • Contact:
          • Phone Number: +3250365155
      • Brussels, Belgium, 1090
        • Not yet recruiting
        • UZ Brussel
        • Contact:
          • Phone Number: +32 2 477 6811
        • Principal Investigator:
          • Sebastien Kindt
      • Edegem, Belgium, 2650
        • Not yet recruiting
        • Antwerp University Hospital
        • Principal Investigator:
          • Heiko De Schepper
        • Contact:
          • Phone Number: 03 821 30 00
      • Ghent, Belgium, 9000
        • Not yet recruiting
        • UZ Gent
        • Contact:
          • Phone Number: 093325166
        • Principal Investigator:
          • Danny De Looze
      • Ghent, Belgium, 9000
        • Not yet recruiting
        • AZ Maria Middelares
        • Principal Investigator:
          • Didier Baert
        • Contact:
          • Phone Number: +3292467100
      • Ghent, Belgium, 9000
        • Not yet recruiting
        • AZ Sint-Lucas
        • Contact:
          • Phone Number: 092245335
        • Principal Investigator:
          • Frederik de Clerck
      • Leuven, Belgium, 3000
        • Not yet recruiting
        • UZ Leuven
        • Principal Investigator:
          • Jan Tack
        • Contact:
          • Phone Number: +3216344225
      • Liège, Belgium, 4000
        • Not yet recruiting
        • Clinical Chc Montlégia
        • Contact:
          • Phone Number: +3243554211
        • Principal Investigator:
          • Boris Bastens
      • Roeselare, Belgium, 8800
        • Not yet recruiting
        • AZ Delta vzw
        • Contact:
          • Phone Number: +32 51 23 72 15
        • Principal Investigator:
          • Jolien Schol
  • Canada
      • Sarnia, Canada, N7T 4X3
        • Not yet recruiting
        • Bluewater Clinical Research Group Inc.
        • Principal Investigator:
          • John O'Mahony
        • Contact:
          • Phone Number: 1 (519) 344-6612
      • Scarborough, Canada, M1B 3V4
        • Not yet recruiting
        • Scarborough Center for Inflammatory Bowel Disease
        • Principal Investigator:
          • Jason Reinglas
      • Scarborough, Canada, M1R 0B1
        • Not yet recruiting
        • ClinSurge Research - LMC Scarborough / Malvern Medical Centre
        • Principal Investigator:
          • Dale Connor
      • Stouffville, Canada, L4A 1H2
        • Not yet recruiting
        • Stouffville Medical Research Institute Inc.
        • Principal Investigator:
          • Nima Mirtorabi
        • Contact:
          • Phone Number: (905) 640-3100
      • Toronto, Canada, M3J 0K2
        • Not yet recruiting
        • Canadian Phase Onward
        • Principal Investigator:
          • Leslie Housefather
  • China
      • Binzhou, China, 256603
        • Not yet recruiting
        • Binzhou Medical University Hospital
        • Principal Investigator:
          • Ning Shi
      • Chengdu, China, 610072
        • Not yet recruiting
        • Sichuan Provincial People'S Hospital
        • Principal Investigator:
          • Chao Zhou
      • Guangzhou, China, 510080
        • Not yet recruiting
        • The First Affiliated Hospital, Sun Yat-Sen University
        • Contact:
          • Phone Number: 86-20-87332916
        • Principal Investigator:
          • Yinglian Xiao
      • Hangzhou, China, 310000
        • Not yet recruiting
        • Zhejiang Hospital of Traditioal Chinese Medicine
        • Principal Investigator:
          • Bin Lv
      • Hengyang, China, 421200
        • Not yet recruiting
        • The Second Affiliated Hospital of University of South China
        • Principal Investigator:
          • Honghui Chen
      • Huizhou, China, 516001
        • Not yet recruiting
        • Huizhou Central People's Hospital
        • Principal Investigator:
          • Huixin Chen
      • Huzhou, China, 313000
        • Not yet recruiting
        • Huzhou Central Hospital
        • Principal Investigator:
          • Wei Wu
      • Meihekou, China, 135000
        • Not yet recruiting
        • Meihekou Central Hospital
        • Principal Investigator:
          • Zhongwei Pan
      • Quzhou, China, 324000
        • Not yet recruiting
        • Quzhou people's Hospital
        • Principal Investigator:
          • Jianguang Xu
      • Taian, China, 271000
        • Not yet recruiting
        • Taian City Central Hospital
        • Principal Investigator:
          • Haipeng Yuan
        • Contact:
          • Phone Number: 13375387610
      • Xianning, China, 437100
        • Not yet recruiting
        • Xianning Central Hospital
        • Principal Investigator:
          • Jianguang Xiong
      • Yichun, China, 336000
        • Not yet recruiting
        • Yichun People's Hospital
        • Principal Investigator:
          • Huizhen Fan
  • Germany
      • Berlin, Germany, 10629
        • Not yet recruiting
        • FutureMeds GmbH
        • Contact:
          • Phone Number: 030 3101360
        • Principal Investigator:
          • Saskia Kerschischnik
      • Dachau, Germany, 85221
        • Not yet recruiting
        • Studienzentrum MVZ Dachau
        • Principal Investigator:
          • Wilfred Landry
        • Contact:
          • Phone Number: 004981316119311
      • Hamburg, Germany, 20253
        • Not yet recruiting
        • Klinische Forschung Hamburg
        • Contact:
          • Phone Number: 00494046076323
        • Principal Investigator:
          • Marret Mehrwald
      • Karlsruhe, Germany, 76137
        • Not yet recruiting
        • Klinische Forschung Karlsruhe
        • Principal Investigator:
          • Alla Reimer
        • Contact:
          • Phone Number: 0049 721 89 34 926
      • Leipzig, Germany, 04107
        • Not yet recruiting
        • AmBeNet GmbH
        • Contact:
          • Phone Number: 4934196276326
        • Principal Investigator:
          • Hans-Detlev Stahl
      • Offenbach, Germany, 63065
        • Not yet recruiting
        • Dedicated Research Site FutureMeds
        • Contact:
          • Phone Number: 069247433849
        • Principal Investigator:
          • Maximilian Boehme
  • Japan
      • Chūōku, Japan, 103-0027
        • Not yet recruiting
        • Tokyo-Eki Center-building Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Arihiro Kiyosue
      • Fujiidera, Japan, 583-0027
        • Not yet recruiting
        • Sai Gastroenterology/Proctology Clinic
        • Principal Investigator:
          • Souken Sai
        • Contact:
          • Phone Number: 81120023812
      • Isehara, Japan, 259-1193
        • Not yet recruiting
        • Tokai University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hidekazu Suzuki
      • Kobe, Japan, 650-0015
        • Not yet recruiting
        • Aoyama Internal Medicine Clinic
        • Principal Investigator:
          • Nobuo Aoyama
        • Contact:
          • Phone Number: 81120023812
      • Kobe, Japan, 657-0841
        • Not yet recruiting
        • Aono Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Satoshi Aono
      • Kumamoto, Japan, 860-0004
        • Not yet recruiting
        • Hattori Clinic - Kumamoto
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • KOICHI SAKURAI
      • Sapporo, Japan, 060-0042
        • Not yet recruiting
        • Sapporo Odori Endoscope Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Shinya Mitsui
      • Shinjuku-Ku, Japan, 160-0023
        • Not yet recruiting
        • Nishi-Shinjuku Kisaragi Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Takayuki Ishikawa
  • Mexico
      • Ciudad de Tijuana, Mexico, 22105
        • Not yet recruiting
        • Scientia Investigacion Clinica Tj
        • Principal Investigator:
          • Luis Lopez
      • Cuernavaca, Mexico, 62448
        • Not yet recruiting
        • Investigación Clínica Cuernavaca, S.C.
        • Principal Investigator:
          • Izchel Donají Sánchez
      • Guadalajara, Mexico, 44650
        • Not yet recruiting
        • Clinica de Investigacion en Reumatologia y Obesidad S. C.
        • Principal Investigator:
          • Hector Martinez Torres
      • Irapuato, Mexico, 36520
        • Not yet recruiting
        • Proactive CR México SA de CV
        • Principal Investigator:
          • Andrés Mendoza Sanchez
      • Mexico City, Mexico, 04100
        • Not yet recruiting
        • Centro de Investigacion Clinica Chapultepec
        • Principal Investigator:
          • Elda Rodriguez Negrete
      • Mexico City, Mexico, 07760
        • Not yet recruiting
        • Hospital Juárez de México
        • Principal Investigator:
          • Eumir Juarez-Valdes
      • Mérida, Mexico, 97070
        • Not yet recruiting
        • Köhler & Milstein Research S.A. de C.V.
        • Contact:
          • Phone Number: 529999204004
        • Principal Investigator:
          • Jose Alcocer Tamayo
      • Tlalnepantla, Mexico, 54055
        • Not yet recruiting
        • Clinical Research Institute S.C.
        • Principal Investigator:
          • Deyanira Kusulas
      • Torreón, Mexico, 27000
        • Not yet recruiting
        • CIMAB SA de CV
        • Principal Investigator:
          • Violeta Silva Sánchez Álvarez
      • Zapopan, Mexico, 45070
        • Not yet recruiting
        • Núcleo de Investigación Médica Sur de Guadalajara
        • Contact:
          • Phone Number: 3317246375
        • Principal Investigator:
          • Rodrigo Nava Arceo
  • Poland
      • Katowice, Poland, 40-600
        • Not yet recruiting
        • Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
        • Principal Investigator:
          • Marek Olakowski
      • Piotrkow Trybunalski, Poland, 97-300
        • Not yet recruiting
        • IRMED
        • Principal Investigator:
          • Katarzyna Ostrowska
      • Poznan, Poland, 60-324
        • Not yet recruiting
        • Twoja Przychodnia PCM
        • Contact:
          • Phone Number: +48 724 444 299
        • Principal Investigator:
          • Ewa Furmanowska-Ladorska
      • Szczecin, Poland, 71-434
        • Not yet recruiting
        • Twoja Przychodnia SCM
        • Principal Investigator:
          • Beata Gawdis-Wojnarska
        • Contact:
          • Phone Number: 48 91 433 29 19
      • Warsaw, Poland, 04-501
        • Not yet recruiting
        • Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
        • Principal Investigator:
          • Jaroslaw Kierkus
        • Contact:
          • Phone Number: 500111648
      • Warsaw, Poland, 02-786
        • Not yet recruiting
        • WSD Medi
        • Principal Investigator:
          • Michal Krogulecki
        • Contact:
          • Phone Number: +48 504 440 092
      • Zamość, Poland, 22-400
        • Not yet recruiting
        • ETG Zamosc
        • Principal Investigator:
          • Katarzyna Wojcik
        • Contact:
          • Phone Number: 48606930022
  • Spain
      • Barcelona, Spain, 08035
        • Not yet recruiting
        • Hospital Universitari Vall d'Hebron
        • Principal Investigator:
          • Carmen Alonso-Cotoner
      • Centelles, Spain, 08540
        • Not yet recruiting
        • EAP Osona Sud - Alt Congost S.L.P
        • Principal Investigator:
          • Emilia Ruthy Acosta Rojas
      • Granada, Spain, 18014
        • Not yet recruiting
        • Hospital Universitario Virgen Nieves
        • Contact:
          • Phone Number: 0034958020134
        • Principal Investigator:
          • BLANCA SERRANO FALCON
      • Madrid, Spain, 28040
        • Not yet recruiting
        • Hospital Clínico San Carlos
        • Principal Investigator:
          • Enrique Rey
        • Contact:
          • Phone Number: +349133000
      • Madrid, Spain, 28222
        • Not yet recruiting
        • Hospital Universitario Puerta de Hierro Majadahonda
        • Principal Investigator:
          • Virginia Matallana Royo
      • Marbella, Spain, 29603
        • Not yet recruiting
        • Hospital Costa Del Sol
        • Principal Investigator:
          • ANGELES Perez Aisa
        • Contact:
          • Phone Number: 686487983
      • Salamanca, Spain, 37007
        • Not yet recruiting
        • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
        • Contact:
          • Phone Number: 923291100
        • Principal Investigator:
          • FERNANDO GEIJO
      • Santiago de Compostela, Spain, 15702
        • Not yet recruiting
        • Clínica Gaias - Santiago
        • Contact:
          • Phone Number: 0034881850285
        • Principal Investigator:
          • Ana Alvarez Castro
  • United Kingdom
      • Cheadle, United Kingdom, ST10 1NS
        • Not yet recruiting
        • Cheadle Community Hospital
        • Principal Investigator:
          • Mark Stone
        • Contact:
          • Phone Number: 07452948414
      • Durham, United Kingdom, DH1 5TW
        • Not yet recruiting
        • University Hospital of North Durham
        • Principal Investigator:
          • yan yiannakou
        • Contact:
          • Phone Number: 07926550949
      • Hounslow, United Kingdom, TW4 7NR
        • Not yet recruiting
        • HMC Health Group - Meadows Centre for Health
        • Principal Investigator:
          • Ivor Singh
        • Contact:
          • Phone Number: 07946732168
      • Macclesfield, United Kingdom, SK10 4TF
        • Not yet recruiting
        • EMS Healthcare
        • Principal Investigator:
          • Matthew Glaves
        • Contact:
          • Phone Number: 0151 350 1590
      • Newquay, United Kingdom, TR7 1RU
        • Not yet recruiting
        • Newquay Health Centre
        • Principal Investigator:
          • Nicholas Jacobsen
        • Contact:
          • Phone Number: 01637 850002
      • Rotherham, United Kingdom, S61 1AH
        • Not yet recruiting
        • Woodstock Bower Surgery
        • Contact:
          • Phone Number: 07551985998
        • Principal Investigator:
          • Shahbaz Ali
      • Surrey, United Kingdom, RH3 7NJ
        • Not yet recruiting
        • Brockwood Medical Practice
        • Contact:
          • Phone Number: 07739010604
        • Principal Investigator:
          • Simone Pereira
      • Sutton in Ashfield, United Kingdom, NG17 4JL
        • Not yet recruiting
        • King's Mill Hospital
        • Principal Investigator:
          • Stephen Foley
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Not yet recruiting
        • Del Sol Research Management - Mesa
        • Contact:
          • Phone Number: 520-257-3881
        • Principal Investigator:
          • David Tessler
    • California
      • Anaheim, California, United States, 92806
        • Not yet recruiting
        • Smart Cures Clinical Research
        • Principal Investigator:
          • Dennis Riff
      • Lancaster, California, United States, 93534
        • Not yet recruiting
        • Om Research LLC
        • Principal Investigator:
          • Jatinder Pruthi
        • Contact:
          • Phone Number: 6613882239
      • Los Alamitos, California, United States, 90720
        • Not yet recruiting
        • United Medical Doctors - Los Alamitos
        • Principal Investigator:
          • Seyedehsan Navabi
        • Contact:
          • Phone Number: 5624304449
    • Florida
      • Hollywood, Florida, United States, 33024
        • Not yet recruiting
        • Encore Medical Research
        • Principal Investigator:
          • Rodolfo Perez
        • Contact:
          • Phone Number: 9544001725
      • Kissimmee, Florida, United States, 34741
        • Not yet recruiting
        • Clinical Research of Osceola
        • Principal Investigator:
          • Basher Atiquzzaman
        • Contact:
          • Phone Number: 4079544016
    • Illinois
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Springfield Clinic - First
        • Principal Investigator:
          • Rajan Kochar
        • Contact:
          • Phone Number: 2175287541
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Not yet recruiting
        • Gastroenterology Health Partners
        • Contact:
          • Phone Number: 812-206-1702
        • Principal Investigator:
          • Jonathan Obert
    • Kentucky
      • Louisville, Kentucky, United States, 40218
        • Not yet recruiting
        • Gastroenterology Health Partners
        • Principal Investigator:
          • Michael Krease
        • Contact:
          • Phone Number: 5028881988
    • Michigan
      • Wyoming, Michigan, United States, 49519
        • Not yet recruiting
        • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
        • Principal Investigator:
          • Allan Coates
    • Ohio
      • Columbus, Ohio, United States, 43202
        • Not yet recruiting
        • Ohio Gastroenterology
        • Principal Investigator:
          • Ryan Gaible
        • Contact:
          • Phone Number: 614-754-5500
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Not yet recruiting
        • University Gastroenterology
        • Principal Investigator:
          • Lisa Mueller
        • Contact:
          • Phone Number: 401-421-8800
    • Texas
      • McAllen, Texas, United States, 78503
        • Not yet recruiting
        • Biopharma Informatic, LLC
        • Principal Investigator:
          • Ralph Alhalel, MD
        • Contact:
          • Phone Number: (281) 944-3610
      • San Antonio, Texas, United States, 78229
        • Not yet recruiting
        • Southern Star Research Institute
        • Contact:
          • Phone Number: 210-581-2812
        • Principal Investigator:
          • Jeff Bullock

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo administered SC
Drug: Placebo
Administered SC
Experimental: LY3537031
LY3537031 administered subcutaneously (SC)
Drug: LY3537031
Administered SC
Other Names:
  • Brenipatide

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Who Had a Daily Abdominal Pain Response for at Least 50% of Days
Time Frame: Week 9 to Week 16
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
Week 1 to Week 24
Percentage of Participants Who Had a Daily Composite Response
Time Frame: Day 1 through Week 24
Day 1 through Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

April 16, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27805
  • J2S-MC-GZMS (Other Identifier: Eli Lilly and Company)
  • 2025-524973-17-00 (Other Identifier: EU Trial (CTIS) Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication or approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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