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Irritable Bowel SyndromePhase 2RENEW-IBS-DNCT07545759

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

A Phase 2 study testing LY3537031 in people with Irritable Bowel Syndrome and Diarrhea, run by Eli Lilly and Company at 89 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Irritable Bowel Syndrome, Diarrhea
What is being tested?
LY3537031
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
531 participants
Where
89 sitesin 10 countries
Study dates
6 May 2026to Nov 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

89 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

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

1-317-615-4559

LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact contact

clinical_inquiry_hub@lilly.com

89 sites in 10 countries

United States15 sites, 15 recruiting

  • Smart Cures Clinical Research

    Anaheim, California, 92806

    Dennis Riff

    Recruiting

  • Ohio Gastroenterology

    Columbus, Ohio, 43202

    614-754-5500

    Ryan Gaible

    Recruiting

  • Encore Medical Research

    Hollywood, Florida, 33024

    954-400-1725

    Rodolfo Perez

    Recruiting

  • Clinical Research of Osceola

    Kissimmee, Florida, 34741

    407-954-4016

    Basher Atiquzzaman

    Recruiting

  • Om Research LLC

    Lancaster, California, 93534

    661-388-2239

    Jatinder Pruthi

    Recruiting

  • United Medical Doctors - Los Alamitos

    Los Alamitos, California, 90720

    562-430-4449

    Seyedehsan Navabi

    Recruiting

  • Gastroenterology Health Partners

    Louisville, Kentucky, 40218

    502-888-1988

    Michael Krease

    Recruiting

  • Biopharma Informatic, LLC

    McAllen, Texas, 78503

    281-944-3610

    Ralph Alhalel, MD

    Recruiting

  • Del Sol Research Management - Mesa

    Mesa, Arizona, 85206

    520-257-3881

    David Tessler

    Recruiting

  • Gastroenterology Health Partners

    New Albany, Indiana, 47150

    812-206-1702

    Jonathan Obert

    Recruiting

  • University Gastroenterology

    Providence, Rhode Island, 02905

    401-421-8800

    Lisa Mueller

    Recruiting

  • Mayo Clinic in Rochester, Minnesota

    Rochester, Minnesota, 55905

    507-266-1685

    Houssam Halawi

    Not yet recruiting

  • Southern Star Research Institute

    San Antonio, Texas, 78229

    210-581-2812

    Jeff Bullock

    Recruiting

  • Springfield Clinic - First

    Springfield, Illinois, 62702

    217-528-7541

    Rajan Kochar

    Recruiting

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

    Wyoming, Michigan, 49519

    Allan Coates

    Recruiting

Other trials in United States

China12 sites, 12 recruiting

  • Binzhou Medical University Hospital

    Binzhou, 256603

    Ning Shi

    Recruiting

  • Sichuan Provincial People's Hospital

    Chengdu, 610072

    Chao Zhou

    Recruiting

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, 510080

    86-20-87332916

    Yinglian Xiao

    Recruiting

  • Zhejiang Hospital of Traditioal Chinese Medicine

    Hangzhou, 310006

    Bin Lv

    Recruiting

  • The Second Affiliated Hospital of University of South China

    Hengyang, 421200

    Honghui Chen

    Recruiting

  • Huizhou Central People's Hospital

    Huizhou, 516001

    Huixin Chen

    Recruiting

  • Huzhou Central Hospital

    Huzhou, 313000

    Wei Wu

    Recruiting

  • Meihekou Central Hospital

    Meihekou, 135000

    Zhongwei Pan

    Recruiting

  • Quzhou People's Hospital

    Quzhou, 324000

    Jianguang Xu

    Recruiting

  • Taian City Central Hospital

    Taian, 271000

    13375387610

    Haipeng Yuan

    Recruiting

  • Xianning Central Hospital

    Xianning, 437100

    Jianguang Xiong

    Recruiting

  • Yichun People's Hospital

    Yichun, 336000

    Huizhen Fan

    Recruiting

Other trials in China

Belgium10 sites, 10 recruiting

  • Sint Vincentius Ziekenhuis

    Antwerp, 2018

    003232852814

    Sara Nullens

    Not yet recruiting

  • AZ Sint-Lucas

    Bruges, 8310

    +3250365155

    Joris Arts

    Not yet recruiting

  • UZ Brussel

    Brussels, 1090

    +3224776811

    Sebastien Kindt

    Not yet recruiting

  • Antwerp University Hospital

    Edegem, 2650

    03 821 30 00

    Heiko De Schepper

    Not yet recruiting

  • AZ Maria Middelares

    Ghent, 9000

    +3292467100

    Didier Baert

    Recruiting

  • AZ Sint-Lucas

    Ghent, 9000

    092245335

    Frederik de Clerck

    Recruiting

  • UZ Gent

    Ghent, 9000

    093325166

    Danny De Looze

    Not yet recruiting

  • UZ Leuven

    Leuven, 3000

    +3216344225

    Jan Tack

    Recruiting

  • Clinical Chc Montlégia

    Liège, 4000

    +3243554211

    Boris Bastens

    Recruiting

  • AZ Delta vzw

    Roeselare, 8800

    +32 51 23 72 15

    Jolien Schol

    Recruiting

Other trials in Belgium

Mexico10 sites, 10 recruiting

  • Scientia Investigacion Clinica Tj

    Ciudad de Tijuana, 22105

    Luis Lopez

    Recruiting

  • Investigación Clínica Cuernavaca, S.C.

    Cuernavaca, 62448

    +52 5519192178

    Izchel Donají Sánchez

    Recruiting

  • Clinica de Investigacion en Reumatologia y Obesidad S. C.

    Guadalajara, 44650

    Hector Martinez Torres

    Recruiting

  • Proactive CR México SA de CV

    Irapuato, 36520

    Andrés Mendoza Sanchez

    Not yet recruiting

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

    Mérida, 97070

    529999204004

    Jose Alcocer Tamayo

    Recruiting

  • Centro de Investigación Clinica Chapultepec

    Mexico City, 04100

    Elda Rodriguez Negrete

    Recruiting

  • Hospital Juarez de Mexico

    Mexico City, 07760

    Eumir Juarez-Valdes

    Not yet recruiting

  • Clinical Research Institute S.C.

    Tlalnepantla, 54055

    Deyanira Kusulas

    Recruiting

  • CIMAB SA de CV

    Torreón, 27000

    Violeta Silva Sánchez Álvarez

    Recruiting

  • Núcleo de Investigación Médica Sur de Guadalajara

    Zapopan, 45070

    3317246375

    Rodrigo Nava Arceo

    Recruiting

Other trials in Mexico

Japan8 sites, 8 recruiting

  • Tokyo-Eki Center-building Clinic

    Chūōku, 103-0027

    81120023812

    Arihiro Kiyosue

    Recruiting

  • Sai Gastroenterology/Proctology Clinic

    Fujiidera, 583-0027

    81120023812

    Souken Sai

    Recruiting

  • Tokai University Hospital

    Isehara, 259-1193

    81120023812

    Hidekazu Suzuki

    Recruiting

  • Aoyama Internal Medicine Clinic

    Kobe, 650-0015

    81120023812

    Nobuo Aoyama

    Recruiting

  • Aono Clinic

    Kobe, 657-0841

    81120023812

    Satoshi Aono

    Recruiting

  • Hattori Clinic - Kumamoto

    Kumamoto, 860-0004

    81120023812

    KOICHI SAKURAI

    Recruiting

  • Sapporo Odori Endoscope Clinic

    Sapporo, 060-0042

    81120023812

    Shinya Mitsui

    Recruiting

  • Nishi-Shinjuku Kisaragi Clinic

    Shinjuku-Ku, 160-0023

    81120023812

    Takayuki Ishikawa

    Recruiting

Other trials in Japan

Spain8 sites, 8 recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

    Carmen Alonso-Cotoner

    Recruiting

  • EAP Osona Sud - Alt Congost S.L.P

    Centelles, 08540

    Emilia Ruthy Acosta Rojas

    Recruiting

  • Hospital Universitario Virgen Nieves

    Granada, 18014

    0034958020134

    BLANCA SERRANO FALCON

    Recruiting

  • Hospital Clinico San Carlos

    Madrid, 28040

    +349133000

    Enrique Rey

    Recruiting

  • Hospital Universitario Puerta de Hierro Majadahonda

    Madrid, 28222

    Virginia Matallana Royo

    Recruiting

  • Hospital Costa del Sol

    Marbella, 29603

    686487983

    ANGELES Perez Aisa

    Recruiting

  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

    Salamanca, 37007

    923291100

    FERNANDO GEIJO

    Recruiting

  • Clínica Gaias - Santiago

    Santiago de Compostela, 15702

    0034881850285

    Ana Alvarez Castro

    Recruiting

Other trials in Spain

United Kingdom8 sites, 8 recruiting

  • Cheadle Community Hospital

    Cheadle, ST10 1NS

    07452948414

    Mark Stone

    Recruiting

  • HMC Health Group - Meadows Centre for Health

    Hounslow, TW4 7NJ

    07946732168

    Ivor Singh

    Recruiting

  • EMS Healthcare

    Leigh, WN75RZ

    0151 350 1590

    Matthew Glaves

    Recruiting

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

    Ashley Price

    Recruiting

  • Newquay Health Centre

    Newquay, TR7 1RU

    01637 850002

    Nicholas Jacobsen

    Recruiting

  • Woodstock Bower Surgery

    Rotherham, S61 1AH

    07551985998

    Shahbaz Ali

    Recruiting

  • Brockwood Medical Practice

    Surrey, RH3 7NJ

    01306 735459

    Simone Pereira

    Recruiting

  • King's Mill Hospital

    Sutton in Ashfield, NG17 4JL

    Stephen Foley

    Recruiting

Other trials in United Kingdom

Poland7 sites, 7 recruiting

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

    Katowice, 40-600

    Marek Olakowski

    Recruiting

  • IRMED

    Piotrkow Trybunalski, 97-300

    Katarzyna Ostrowska

    Recruiting

  • Twoja Przychodnia PCM

    Poznan, 60-324

    +48 724 444 299

    Ewa Furmanowska-Ladorska

    Recruiting

  • Twoja Przychodnia SCM

    Szczecin, 71-434

    48 91 433 29 19

    Beata Gawdis-Wojnarska

    Recruiting

  • WSD MEDI

    Warsaw, 02-786

    +48 504 440 092

    Michal Krogulecki

    Not yet recruiting

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

    Warsaw, 04-501

    500111648

    Jaroslaw Kierkus

    Recruiting

  • ETG Zamość

    Zamość, 22-400

    48606930022

    Katarzyna Wojcik

    Recruiting

Other trials in Poland

Germany6 sites, 6 recruiting

  • FutureMeds GmbH

    Berlin, 10629

    030 3101360

    Saskia Kerschischnik

    Recruiting

  • Studienzentrum MVZ Dachau

    Dachau, 85221

    004981316119311

    Wilfred Landry

    Recruiting

  • Pratia - Hamburg

    Hamburg, 20253

    00494046076323

    Marret Mehrwald

    Recruiting

  • Klinische Forschung Karlsruhe

    Karlsruhe, 76137

    0049 721 89 34 926

    Alla Reimer

    Recruiting

  • AmBeNet GmbH

    Leipzig, 04107

    4934196276326

    Hans-Detlev Stahl

    Recruiting

  • FutureMeds Offenbach

    Offenbach, 63065

    069247433849

    Maximilian Boehme

    Recruiting

Other trials in Germany

Canada5 sites, 5 recruiting

  • Bluewater Clinical Research Group Inc.

    Sarnia, N7T 4X3

    1 (519) 344-6612

    John O'Mahony

    Recruiting

  • Scarborough Center for Inflammatory Bowel Disease

    Scarborough, M1B 3V4

    Jason Reinglas

    Recruiting

  • ClinSurge Research - LMC Scarborough / Malvern Medical Centre

    Scarborough, M1R 0B1

    Dale Connor

    Recruiting

  • Stouffville Medical Research Institute Inc.

    Stouffville, L4A 1H2

    (905) 640-3100

    Nima Mirtorabi

    Recruiting

  • Canadian Phase Onward

    Toronto, M3J 0K2

    Leslie Housefather

    Recruiting

Other trials in Canada

About this study

Official title: 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 36 weeks.

Being tested
LY3537031, Placebo
Medical subject headings
Irritable Bowel Syndrome, Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3537031Drug

    Also called Brenipatide

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT07545759
Study groupRoleWhat they receive
LY3537031ExperimentalLY3537031 administered subcutaneously (SC)
Receives: Drug: LY3537031
PlaceboPlacebo comparatorPlacebo administered SC
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Had a Daily Composite Response for at Least 50 Percent (%) of Days

    Measured: Week 9 to Week 16

Secondary outcomes (3)

  1. Percentage of Participants Who Had a Daily Abdominal Pain Response for at Least 50% of Days

    Measured: Week 9 to Week 16

  2. Percentage of Participants Who Had Daily Stool Consistency Response for at Least 50% of Days

    Measured: Week 1 to Week 24

  3. Percentage of Participants Who Had a Daily Composite Response

    Measured: Day 1 through Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2026
  2. Study start6 May 2026
  3. Primary completionSep 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
531 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07545759
Sponsor's protocol ID
27805
Other IDs
J2S-MC-GZMS, 2025-524973-17-00, 2025
Acronym
RENEW-IBS-D
Status last verified
Nov 2026
First submitted
16 Apr 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY3537031 in people with Irritable Bowel Syndrome and Diarrhea, run by Eli Lilly and Company at 89 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United States, China, Belgium, Mexico, Japan and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07545759.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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