What this study is
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.
What's being tested
- LY3537031
Intervention · DRUG
- Placebo
Intervention · DRUG
Both interventions
Administered SC.
Study details
- 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
- Sponsor
- Eli Lilly and Company
- Conditions
- Irritable Bowel Syndrome · Constipation
- Enrolling
- 342 people
- Starts
- 2026-04-29
- Est. completion
- 2027-09
- Design
- Double-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (70)
70 openDel Sol Research Management - Mesa
Mesa, Arizona, United States
- Contact520-257-3881
- David Tessler · Principal investigator
RecruitingSmart Cures Clinical Research
Anaheim, California, United States
- Dennis Riff · Principal investigator
RecruitingOm Research LLC
Lancaster, California, United States
- Contact661-388-2239
- Jatinder Pruthi · Principal investigator
RecruitingUnited Medical Doctors - Los Alamitos
Los Alamitos, California, United States
- Contact562-430-4449
- Seyedehsan Navabi · Principal investigator
RecruitingEncore Medical Research
Hollywood, Florida, United States
- Contact954-400-1725
- Rodolfo Perez · Principal investigator
RecruitingSpringfield Clinic - First
Springfield, Illinois, United States
- Contact217-528-7541
- Rajan Kochar · Principal investigator
RecruitingGastroenterology Health Partners
New Albany, Indiana, United States
- Contact812-206-1702
- Jonathan Obert · Principal investigator
RecruitingGastroenterology Health Partners
Louisville, Kentucky, United States
- Contact502-888-1988
- Michael Krease · Principal investigator
RecruitingNew York Gastroenterology Associates
New York, New York, United States
- Contact212-535-1845
- Yevgenia Pashinsky · Principal investigator
RecruitingOhio Gastroenterology
Columbus, Ohio, United States
- Contact614-754-5500
- Ryan Gaible · Principal investigator
RecruitingUniversity Gastroenterology
Providence, Rhode Island, United States
- Contact401-421-8800
- Lisa Mueller · Principal investigator
RecruitingBiopharma Informatic, LLC
McAllen, Texas, United States
- Contact281-944-3610
- Ralph Alhalel, MD · Principal investigator
RecruitingSouthern Star Research Institute
San Antonio, Texas, United States
- Contact210-581-2812
- Jeff Bullock · Principal investigator
RecruitingGI Alliance-Webster
Webster, Texas, United States
- Sudhanshu Gogia · Principal investigator
Recruiting
56 sites outside the US
- Not yet recruiting
- Not yet recruiting
- Not yet recruiting
Antwerp University Hospital
Edegem, Belgium
- Contact03 821 30 00
- Heiko De Schepper · Principal investigator
Not yet recruiting- Recruiting
- Recruiting
- Not yet recruiting
- Recruiting
- Recruiting
- Recruiting
Bluewater Clinical Research Group Inc.
Sarnia, Canada
- Contact1 (519) 344-6612
- John O'Mahony · Principal investigator
RecruitingScarborough Center for Inflammatory Bowel Disease
Scarborough, Canada
- Jason Reinglas · Principal investigator
RecruitingClinSurge Research - LMC Scarborough / Malvern Medical Centre
Scarborough, Canada
- Dale Connor · Principal investigator
RecruitingStouffville Medical Research Institute Inc.
Stouffville, Canada
- Contact(905) 640-3100
- Nima Mirtorabi · Principal investigator
RecruitingCanadian Phase Onward
Toronto, Canada
- Leslie Housefather · Principal investigator
RecruitingBinzhou Medical University Hospital
Binzhou, China
- Ning Shi · Principal investigator
RecruitingSichuan Provincial People's Hospital
Chengdu, China
- Chao Zhou · Principal investigator
RecruitingThe First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
- Contact86-20-87332916
- Yinglian Xiao · Principal investigator
RecruitingZhejiang Hospital of Traditioal Chinese Medicine
Hangzhou, China
- Bin Lv · Principal investigator
RecruitingThe Second Affiliated Hospital of University of South China
Hengyang, China
- Honghui Chen · Principal investigator
RecruitingHuizhou Central People's Hospital
Huizhou, China
- Huixin Chen · Principal investigator
RecruitingHuzhou Central Hospital
Huzhou, China
- Wei Wu · Principal investigator
RecruitingMeihekou Central Hospital
Meihekou, China
- Zhongwei Pan · Principal investigator
RecruitingQuzhou People's Hospital
Quzhou, China
- Jianguang Xu · Principal investigator
Recruiting- Recruiting
Xianning Central Hospital
Xianning, China
- Jianguang Xiong · Principal investigator
RecruitingYichun People's Hospital
Yichun, China
- Huizhen Fan · Principal investigator
RecruitingTokyo-Eki Center-building Clinic
Chūōku, Japan
- Contact81120023812
- Arihiro Kiyosue · Principal investigator
Recruiting- Recruiting
- Recruiting
Sapporo Odori Endoscope Clinic
Sapporo, Japan
- Contact81120023812
- Shinya Mitsui · Principal investigator
RecruitingNishi-Shinjuku Kisaragi Clinic
Shinjuku-Ku, Japan
- Contact81120023812
- Takayuki Ishikawa · Principal investigator
RecruitingScientia Investigacion Clinica Tj
Ciudad de Tijuana, Mexico
- Luis Lopez · Principal investigator
RecruitingCentro de Investigación y Gastroenterología - S.C.
Mexico City, Mexico
- Contact5510546591
- Alma Ladron de Guevara Cetina · Principal investigator
RecruitingCentro de Investigación Clinica Chapultepec
Mexico City, Mexico
- Elda Rodriguez Negrete · Principal investigator
RecruitingHospital Juarez de Mexico
Mexico City, Mexico
- Eumir Juarez-Valdes · Principal investigator
Not yet recruitingKohler & Milstein Research S.A. De C.V.
Mérida, Mexico
- Contact529999204004
- Jose Alcocer Tamayo · Principal investigator
RecruitingCIMAB SA de CV
Torreón, Mexico
- Violeta Silva Sánchez Álvarez · Principal investigator
RecruitingFAICIC S. de R.L. de C.V.
Veracruz, Mexico
- Contact2299327808
- Aracely Cruz Palacios · Principal investigator
RecruitingNúcleo de Investigación Médica Sur de Guadalajara
Zapopan, Mexico
- Contact3317246375
- Rodrigo Nava Arceo · Principal investigator
RecruitingHospital Universitari Vall d'Hebron
Barcelona, Spain
- Carmen Alonso-Cotoner · Principal investigator
RecruitingEAP Osona Sud - Alt Congost S.L.P
Centelles, Spain
- Emilia Ruthy Acosta Rojas · Principal investigator
RecruitingHospital Universitario Virgen Nieves
Granada, Spain
- Contact0034958020134
- BLANCA SERRANO FALCON · Principal investigator
Recruiting- Recruiting
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Spain
- Virginia Matallana Royo · Principal investigator
Recruiting- Recruiting
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, Spain
- Contact923291100
- FERNANDO GEIJO · Principal investigator
RecruitingClínica Gaias - Santiago
Santiago de Compostela, Spain
- Contact0034881850285
- Ana Alvarez Castro · Principal investigator
RecruitingCheadle Community Hospital
Cheadle, United Kingdom
- Contact07452948414
- Mark Stone · Principal investigator
RecruitingHMC Health Group - Meadows Centre for Health
Hounslow, United Kingdom
- Contact07946732168
- Ivor Singh · Principal investigator
Recruiting- Recruiting
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
- Ashley Price · Principal investigator
RecruitingNewquay Health Centre
Newquay, United Kingdom
- Contact01637 850002
- Nicholas Jacobsen · Principal investigator
RecruitingWoodstock Bower Surgery
Rotherham, United Kingdom
- Contact07551985998
- Shahbaz Ali · Principal investigator
RecruitingBrockwood Medical Practice
Surrey, United Kingdom
- Contact01306 735459
- Simone Pereira · Principal investigator
RecruitingKing's Mill Hospital
Sutton in Ashfield, United Kingdom
- Stephen Foley · Principal investigator
Recruiting
Study team
Sponsor
Eli Lilly and Company
Study ID 27821
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
CONTACT
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.