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

August 21, 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-C

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

342

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
        • Principal Investigator:
          • Sebastien Kindt
        • Contact:
          • Phone Number: +3224776811
      • 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
        • Recruiting
        • Bluewater Clinical Research Group Inc.
        • Principal Investigator:
          • John O'Mahony
        • Contact:
          • Phone Number: 1 (519) 344-6612
      • Scarborough, Canada, M1B 3V4
        • Recruiting
        • Scarborough Center for Inflammatory Bowel Disease
        • Principal Investigator:
          • Jason Reinglas
      • Scarborough, Canada, M1R 0B1
        • Recruiting
        • ClinSurge Research - LMC Scarborough / Malvern Medical Centre
        • Principal Investigator:
          • Dale Connor
      • Stouffville, Canada, L4A 1H2
        • Recruiting
        • Stouffville Medical Research Institute Inc.
        • Principal Investigator:
          • Nima Mirtorabi
        • Contact:
          • Phone Number: (905) 640-3100
      • Toronto, Canada, M3J 0K2
        • Recruiting
        • Canadian Phase Onward
        • Principal Investigator:
          • Leslie Housefather
  • China
      • Binzhou, China, 256603
        • 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
        • Recruiting
        • The First Affiliated Hospital, Sun Yat-sen University
        • Contact:
          • Phone Number: 86-20-87332916
        • Principal Investigator:
          • Yinglian Xiao
      • Hangzhou, China, 310006
        • Recruiting
        • Zhejiang Hospital of Traditioal Chinese Medicine
        • Principal Investigator:
          • Bin Lv
      • Hengyang, China, 421200
        • Recruiting
        • The Second Affiliated Hospital of University of South China
        • Principal Investigator:
          • Honghui Chen
      • Huizhou, China, 516001
        • Recruiting
        • Huizhou Central People's Hospital
        • Principal Investigator:
          • Huixin Chen
      • Huzhou, China, 313000
        • Recruiting
        • Huzhou Central Hospital
        • Principal Investigator:
          • Wei Wu
      • Meihekou, China, 135000
        • Recruiting
        • Meihekou Central Hospital
        • Principal Investigator:
          • Zhongwei Pan
      • Quzhou, China, 324000
        • Recruiting
        • Quzhou People's Hospital
        • Principal Investigator:
          • Jianguang Xu
      • Taian, China, 271000
        • Recruiting
        • Taian City Central Hospital
        • Principal Investigator:
          • Haipeng Yuan
        • Contact:
          • Phone Number: 13375387610
      • Xianning, China, 437100
        • Recruiting
        • Xianning Central Hospital
        • Principal Investigator:
          • Jianguang Xiong
      • Yichun, China, 336000
        • Recruiting
        • Yichun People's Hospital
        • Principal Investigator:
          • Huizhen Fan
  • Japan
      • Chūōku, Japan, 103-0027
        • Recruiting
        • Tokyo-Eki Center-building Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Arihiro Kiyosue
      • Isehara, Japan, 259-1193
        • Recruiting
        • Tokai University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hidekazu Suzuki
      • Kobe, Japan, 657-0841
        • Recruiting
        • Aono Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Satoshi Aono
      • Sapporo, Japan, 060-0042
        • Recruiting
        • Sapporo Odori Endoscope Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Shinya Mitsui
      • Shinjuku-Ku, Japan, 160-0023
        • Recruiting
        • Nishi-Shinjuku Kisaragi Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Takayuki Ishikawa
  • Mexico
      • Ciudad de Tijuana, Mexico, 22105
        • Recruiting
        • Scientia Investigacion Clinica Tj
        • Principal Investigator:
          • Luis Lopez
      • Mexico City, Mexico, 04100
        • Recruiting
        • Centro de Investigacion Clinica Chapultepec
        • Principal Investigator:
          • Elda Rodriguez Negrete
      • Mexico City, Mexico, 07760
        • Not yet recruiting
        • Hospital Juarez de Mexico
        • Principal Investigator:
          • Eumir Juarez-Valdes
      • Mexico City, Mexico, 03330
        • Recruiting
        • Centro de Investigación y Gastroenterología - S.C.
        • Contact:
          • Phone Number: 5510546591
        • Principal Investigator:
          • Alma Ladron de Guevara Cetina
      • Mérida, Mexico, 97070
        • Not yet recruiting
        • Kohler & Milstein Research S.A. De C.V.
        • Contact:
          • Phone Number: 529999204004
        • Principal Investigator:
          • Jose Alcocer Tamayo
      • Torreón, Mexico, 27000
        • Not yet recruiting
        • CIMAB SA de CV
        • Principal Investigator:
          • Violeta Silva Sánchez Álvarez
      • Veracruz, Mexico, 91900
        • Not yet recruiting
        • FAICIC S. de R.L. de C.V.
        • Principal Investigator:
          • Aracely Cruz Palacios
        • Contact:
          • Phone Number: 2299327808
      • Zapopan, Mexico, 45070
        • Not yet recruiting
        • Núcleo de Investigación Médica Sur de Guadalajara
        • Contact:
          • Phone Number: 3317246375
        • Principal Investigator:
          • Rodrigo Nava Arceo
  • Spain
      • Barcelona, Spain, 08035
        • Not yet recruiting
        • Hospital Universitari Vall d'Hebron
        • Principal Investigator:
          • Carmen Alonso-Cotoner
      • Centelles, Spain, 08540
        • 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 Clinico 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
        • Recruiting
        • Clínica Gaias - Santiago
        • Contact:
          • Phone Number: 0034881850285
        • Principal Investigator:
          • Ana Alvarez Castro
  • United Kingdom
      • Cheadle, United Kingdom, ST10 1NS
        • Recruiting
        • Cheadle Community Hospital
        • Principal Investigator:
          • Mark Stone
        • Contact:
          • Phone Number: 07452948414
      • Hounslow, United Kingdom, TW4 7NR
        • Recruiting
        • HMC Health Group - Meadows Centre for Health
        • Principal Investigator:
          • Ivor Singh
        • Contact:
          • Phone Number: 07946732168
      • Macclesfield, United Kingdom, SK10 4TF
        • Recruiting
        • EMS Healthcare
        • Principal Investigator:
          • Matthew Glaves
        • Contact:
          • Phone Number: 0151 350 1590
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Not yet recruiting
        • Royal Victoria Infirmary
        • Principal Investigator:
          • Ashley Price
      • Newquay, United Kingdom, TR7 1RU
        • Recruiting
        • Newquay Health Centre
        • Principal Investigator:
          • Nicholas Jacobsen
        • Contact:
          • Phone Number: 01637 850002
      • Rotherham, United Kingdom, S61 1AH
        • Recruiting
        • Woodstock Bower Surgery
        • Contact:
          • Phone Number: 07551985998
        • Principal Investigator:
          • Shahbaz Ali
      • Surrey, United Kingdom, RH3 7NJ
        • Recruiting
        • Brockwood Medical Practice
        • Principal Investigator:
          • Simone Pereira
        • Contact:
          • Phone Number: 01306 735459
      • Sutton in Ashfield, United Kingdom, NG17 4JL
        • Recruiting
        • King's Mill Hospital
        • Principal Investigator:
          • Stephen Foley
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Recruiting
        • Del Sol Research Management - Mesa
        • Contact:
          • Phone Number: 520-257-3881
        • Principal Investigator:
          • David Tessler
    • California
      • Anaheim, California, United States, 92806
        • Recruiting
        • Smart Cures Clinical Research
        • Principal Investigator:
          • Dennis Riff
      • Lancaster, California, United States, 93534
        • Recruiting
        • Om Research LLC
        • Principal Investigator:
          • Jatinder Pruthi
        • Contact:
          • Phone Number: 661-388-2239
      • Los Alamitos, California, United States, 90720
        • Recruiting
        • United Medical Doctors - Los Alamitos
        • Contact:
          • Phone Number: 562-430-4449
        • Principal Investigator:
          • Seyedehsan Navabi
    • Florida
      • Hollywood, Florida, United States, 33024
        • Recruiting
        • Encore Medical Research
        • Contact:
          • Phone Number: 954-400-1725
        • Principal Investigator:
          • Rodolfo Perez
    • Illinois
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Springfield Clinic - First
        • Contact:
          • Phone Number: 217-528-7541
        • Principal Investigator:
          • Rajan Kochar
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Recruiting
        • Gastroenterology Health Partners
        • Contact:
          • Phone Number: 812-206-1702
        • Principal Investigator:
          • Jonathan Obert
    • Kentucky
      • Louisville, Kentucky, United States, 40218
        • Recruiting
        • Gastroenterology Health Partners
        • Principal Investigator:
          • Michael Krease
        • Contact:
          • Phone Number: 502-888-1988
    • New York
      • New York, New York, United States, 10075
        • Recruiting
        • New York Gastroenterology Associates
        • Contact:
          • Phone Number: 212-535-1845
        • Principal Investigator:
          • Yevgenia Pashinsky
    • Ohio
      • Columbus, Ohio, United States, 43202
        • Recruiting
        • Ohio Gastroenterology
        • Principal Investigator:
          • Ryan Gaible
        • Contact:
          • Phone Number: 614-754-5500
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Recruiting
        • University Gastroenterology
        • Principal Investigator:
          • Lisa Mueller
        • Contact:
          • Phone Number: 401-421-8800
    • Texas
      • McAllen, Texas, United States, 78503
        • Recruiting
        • Biopharma Informatic, LLC
        • Principal Investigator:
          • Ralph Alhalel, MD
        • Contact:
          • Phone Number: 281-944-3610
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Southern Star Research Institute
        • Contact:
          • Phone Number: 210-581-2812
        • Principal Investigator:
          • Jeff Bullock
      • Webster, Texas, United States, 77598
        • Recruiting
        • GI Alliance-Webster
        • Principal Investigator:
          • Sudhanshu Gogia

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:

  • 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

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 with a Weekly Composite Clinical Response for at Least 50 Percent (%) of Weeks
Time Frame: Week 9 to 16
Week 9 to 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with a Weekly Abdominal Pain Response for at Least 50% of Weeks
Time Frame: Week 9 to 16
Week 9 to 16
Percentage of Participants with a Weekly Complete Spontaneous Bowel Movement (CSBM) for at Least 50% of Weeks
Time Frame: Week 9 to 16
Week 9 to 16

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

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)

April 29, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

September 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)

August 24, 2026

Last Update Submitted That Met QC Criteria

August 21, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27821
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • J2S-MC-GZMT (Other Identifier: Eli Lilly and Company)
  • 2025-524974-41-00 (Ctis)

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 EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal should be approved by an independent review panel and researchers should 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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