Irritable Bowel SyndromePhase 2RENEW-IBS-CNCT07545772
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
A Phase 2 study testing LY3537031 in people with Irritable Bowel Syndrome and Constipation, run by Eli Lilly and Company at 70 sites in 8 countries.
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-Constipation (IBS-C). 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, Constipation
- 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
- 342 participants
- Where
- 70 sitesin 8 countries
- Study dates
- 29 Apr 2026to Sep 2027
- Phase
- Phase 2
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
- 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
Who cannot join
- 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
Trial locations and contacts
70 sites in 8 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
Physicians interested in becoming principal investigators please contact contact
70 sites in 8 countries
United States14 sites, 14 recruiting
- 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
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
New York Gastroenterology Associates
New York, New York, 10075
212-535-1845
Yevgenia Pashinsky
- Recruiting
University Gastroenterology
Providence, Rhode Island, 02905
401-421-8800
Lisa Mueller
- 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
GI Alliance-Webster
Webster, Texas, 77598
Sudhanshu Gogia
China12 sites, 12 recruiting
- 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
Belgium10 sites, 10 recruiting
- Not yet 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
- Not yet recruiting
UZ Gent
Ghent, 9000
093325166
Danny De Looze
- Not yet recruiting
UZ Leuven
Leuven, 3000
+3216344225
Jan Tack
- Not yet recruiting
Clinical Chc Montlégia
Liège, 4000
+3243554211
Boris Bastens
- Not yet recruiting
AZ Delta vzw
Roeselare, 8800
+32 51 23 72 15
Jolien Schol
Mexico8 sites, 8 recruiting
- Recruiting
Scientia Investigacion Clinica Tj
Ciudad de Tijuana, 22105
Luis Lopez
- Recruiting
Kohler & Milstein Research S.A. De C.V.
Mérida, 97070
529999204004
Jose Alcocer Tamayo
- Recruiting
Centro de Investigación y Gastroenterología - S.C.
Mexico City, 03330
5510546591
Alma Ladron de Guevara Cetina
- Recruiting
Centro de Investigación Clinica Chapultepec
Mexico City, 04100
Elda Rodriguez Negrete
- Not yet recruiting
Hospital Juarez de Mexico
Mexico City, 07760
Eumir Juarez-Valdes
- Recruiting
CIMAB SA de CV
Torreón, 27000
Violeta Silva Sánchez Álvarez
- Recruiting
FAICIC S. de R.L. de C.V.
Veracruz, 91900
2299327808
Aracely Cruz Palacios
- Recruiting
Núcleo de Investigación Médica Sur de Guadalajara
Zapopan, 45070
3317246375
Rodrigo Nava Arceo
Spain8 sites, 8 recruiting
- 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
- Not yet 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
United Kingdom8 sites, 8 recruiting
- Recruiting
Cheadle Community Hospital
Cheadle, ST10 1NS
07452948414
Mark Stone
- Recruiting
HMC Health Group - Meadows Centre for Health
Hounslow, TW4 7NR
07946732168
Ivor Singh
- Recruiting
EMS Healthcare
Macclesfield, SK10 4TF
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
Canada5 sites, 5 recruiting
- 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
Japan5 sites, 5 recruiting
- Recruiting
Tokyo-Eki Center-building Clinic
Chūōku, 103-0027
81120023812
Arihiro Kiyosue
- Recruiting
Tokai University Hospital
Isehara, 259-1193
81120023812
Hidekazu Suzuki
- Recruiting
Aono Clinic
Kobe, 657-0841
81120023812
Satoshi Aono
- Recruiting
Sapporo Odori Endoscope Clinic
Sapporo, 060-0042
81120023812
Shinya Mitsui
- Recruiting
Nishi-Shinjuku Kisaragi Clinic
Shinjuku-Ku, 160-0023
81120023812
Takayuki Ishikawa
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-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 36 weeks.
- Conditions
- Irritable Bowel Syndrome, Constipation
- Being tested
- LY3537031, Placebo
- Medical subject headings
- Irritable Bowel Syndrome, Constipation
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 group | Role | What they receive |
|---|---|---|
| LY3537031 | Experimental | LY3537031 administered subcutaneously (SC). Receives: Drug: LY3537031 |
| Placebo | Placebo comparator | Placebo administered SC. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with a Weekly Composite Clinical Response for at Least 50 Percent (%) of Weeks
Measured: Week 9 to 16
Secondary outcomes (2)
Percentage of Participants with a Weekly Abdominal Pain Response for at Least 50% of Weeks
Measured: Week 9 to 16
Percentage of Participants with a Weekly Complete Spontaneous Bowel Movement (CSBM) for at Least 50% of Weeks
Measured: Week 9 to 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start29 Apr 2026
- Primary completionJul 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 342 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545772
- Sponsor's protocol ID
- 27821
- Other IDs
- J2S-MC-GZMT, 2025-524974-41-00, 2025
- Acronym
- RENEW-IBS-C
- Status last verified
- Oct 2026
- First submitted
- 16 Apr 2026
- Last updated
- 8 Oct 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.