A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
RENEW-IBS-D
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
3 other identifiers
interventional
531
10 countries
89
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2026
Shorter than P25 for phase_2
89 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2026
CompletedFirst Posted
Study publicly available on registry
April 22, 2026
CompletedStudy Start
First participant enrolled
May 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
July 17, 2026
July 1, 2026
1.3 years
April 16, 2026
July 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Had a Daily Composite Response for at Least 50 Percent (%) of Days
Week 9 to Week 16
Secondary Outcomes (3)
Percentage of Participants Who Had a Daily Abdominal Pain Response for at Least 50% of Days
Week 9 to Week 16
Percentage of Participants Who Had Daily Stool Consistency Response for at Least 50% of Days
Week 1 to Week 24
Percentage of Participants Who Had a Daily Composite Response
Day 1 through Week 24
Study Arms (2)
LY3537031
EXPERIMENTALLY3537031 administered subcutaneously (SC)
Placebo
PLACEBO COMPARATORPlacebo administered SC
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (89)
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2026
First Posted
April 22, 2026
Study Start
May 6, 2026
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
July 17, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.