Actively Recruiting
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Led by Eli Lilly and Company · Updated on 2026-05-13
531
Participants Needed
88
Research Sites
77 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Have an average worst abdominal pain score of 3 or higher on a 0-to-10 scale during the 14 days before randomization
- Have at least 4 days per week with a maximum BSFS of 5 or more and at least 2 of those days with a maximum BSFS of 6 during the 14 days before randomization
- Have had no major changes in diet in the 4 weeks before screening
You will not qualify if you...
- Diagnosis of IBS with constipation subtype, mixed IBS, or unclassified IBS by Rome IV criteria
- History of inflammatory or immune-mediated gastrointestinal disorders
- Known clinically significant gastric emptying abnormality
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 88 locations
1
Del Sol Research Management - Mesa
Mesa, Arizona, United States, 85206
Not Yet Recruiting
2
Smart Cures Clinical Research
Anaheim, California, United States, 92806
Not Yet Recruiting
3
Om Research LLC
Lancaster, California, United States, 93534
Not Yet Recruiting
4
United Medical Doctors - Los Alamitos
Los Alamitos, California, United States, 90720
Not Yet Recruiting
5
Encore Medical Research
Hollywood, Florida, United States, 33024
Not Yet Recruiting
6
Clinical Research of Osceola
Kissimmee, Florida, United States, 34741
Not Yet Recruiting
7
Springfield Clinic - First
Springfield, Illinois, United States, 62702
Actively Recruiting
8
Gastroenterology Health Partners
New Albany, Indiana, United States, 47150
Not Yet Recruiting
9
Gastroenterology Health Partners
Louisville, Kentucky, United States, 40218
Not Yet Recruiting
10
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
Wyoming, Michigan, United States, 49519
Not Yet Recruiting
11
Ohio Gastroenterology
Columbus, Ohio, United States, 43202
Not Yet Recruiting
12
University Gastroenterology
Providence, Rhode Island, United States, 02905
Not Yet Recruiting
13
Biopharma Informatic, LLC
McAllen, Texas, United States, 78503
Not Yet Recruiting
14
Southern Star Research Institute
San Antonio, Texas, United States, 78229
Not Yet Recruiting
15
Sint Vincentius Ziekenhuis
Antwerp, Belgium, 2018
Not Yet Recruiting
16
AZ Sint-Lucas
Bruges, Belgium, 8310
Not Yet Recruiting
17
UZ Brussel
Brussels, Belgium, 1090
Not Yet Recruiting
18
Antwerp University Hospital
Edegem, Belgium, 2650
Not Yet Recruiting
19
AZ Maria Middelares
Ghent, Belgium, 9000
Not Yet Recruiting
20
AZ Sint-Lucas
Ghent, Belgium, 9000
Not Yet Recruiting
21
UZ Gent
Ghent, Belgium, 9000
Not Yet Recruiting
22
UZ Leuven
Leuven, Belgium, 3000
Not Yet Recruiting
23
Clinical Chc Montlégia
Liège, Belgium, 4000
Not Yet Recruiting
24
AZ Delta vzw
Roeselare, Belgium, 8800
Not Yet Recruiting
25
Bluewater Clinical Research Group Inc.
Sarnia, Canada, N7T 4X3
Not Yet Recruiting
26
Scarborough Center for Inflammatory Bowel Disease
Scarborough, Canada, M1B 3V4
Not Yet Recruiting
27
ClinSurge Research - LMC Scarborough / Malvern Medical Centre
Scarborough, Canada, M1R 0B1
Not Yet Recruiting
28
Stouffville Medical Research Institute Inc.
Stouffville, Canada, L4A 1H2
Not Yet Recruiting
29
Canadian Phase Onward
Toronto, Canada, M3J 0K2
Not Yet Recruiting
30
Binzhou Medical University Hospital
Binzhou, China, 256603
Not Yet Recruiting
31
Sichuan Provincial People's Hospital
Chengdu, China, 610072
Not Yet Recruiting
32
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China, 510080
Not Yet Recruiting
33
Zhejiang Hospital of Traditioal Chinese Medicine
Hangzhou, China, 310000
Not Yet Recruiting
34
The Second Affiliated Hospital of University of South China
Hengyang, China, 421200
Not Yet Recruiting
35
Huizhou Central People's Hospital
Huizhou, China, 516001
Not Yet Recruiting
36
Huzhou Central Hospital
Huzhou, China, 313000
Not Yet Recruiting
37
Meihekou Central Hospital
Meihekou, China, 135000
Not Yet Recruiting
38
Quzhou People's Hospital
Quzhou, China, 324000
Not Yet Recruiting
39
Taian City Central Hospital
Taian, China, 271000
Not Yet Recruiting
40
Xianning Central Hospital
Xianning, China, 437100
Not Yet Recruiting
41
Yichun People's Hospital
Yichun, China, 336000
Not Yet Recruiting
42
FutureMeds GmbH
Berlin, Germany, 10629
Not Yet Recruiting
43
Studienzentrum MVZ Dachau
Dachau, Germany, 85221
Not Yet Recruiting
44
Klinische Forschung Hamburg
Hamburg, Germany, 20253
Not Yet Recruiting
45
Klinische Forschung Karlsruhe
Karlsruhe, Germany, 76137
Not Yet Recruiting
46
AmBeNet GmbH
Leipzig, Germany, 04107
Not Yet Recruiting
47
Dedicated Research Site FutureMeds
Offenbach, Germany, 63065
Not Yet Recruiting
48
Tokyo-Eki Center-building Clinic
Chūōku, Japan, 103-0027
Not Yet Recruiting
49
Sai Gastroenterology/Proctology Clinic
Fujiidera, Japan, 583-0027
Not Yet Recruiting
50
Tokai University Hospital
Isehara, Japan, 259-1193
Not Yet Recruiting
51
Aoyama Internal Medicine Clinic
Kobe, Japan, 650-0015
Not Yet Recruiting
52
Aono Clinic
Kobe, Japan, 657-0841
Not Yet Recruiting
53
Hattori Clinic - Kumamoto
Kumamoto, Japan, 860-0004
Not Yet Recruiting
54
Sapporo Odori Endoscope Clinic
Sapporo, Japan, 060-0042
Not Yet Recruiting
55
Nishi-Shinjuku Kisaragi Clinic
Shinjuku-Ku, Japan, 160-0023
Not Yet Recruiting
56
Scientia Investigacion Clinica Tj
Ciudad de Tijuana, Mexico, 22105
Not Yet Recruiting
57
Investigación Clínica Cuernavaca, S.C.
Cuernavaca, Mexico, 62448
Not Yet Recruiting
58
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, Mexico, 44650
Not Yet Recruiting
59
Proactive CR México SA de CV
Irapuato, Mexico, 36520
Not Yet Recruiting
60
Centro de Investigación Clinica Chapultepec
Mexico City, Mexico, 04100
Not Yet Recruiting
61
Hospital Juarez de Mexico
Mexico City, Mexico, 07760
Not Yet Recruiting
62
Kohler & Milstein Research S.A. De C.V.
Mérida, Mexico, 97070
Not Yet Recruiting
63
Clinical Research Institute S.C.
Tlalnepantla, Mexico, 54055
Not Yet Recruiting
64
CIMAB SA de CV
Torreón, Mexico, 27000
Not Yet Recruiting
65
Núcleo de Investigación Médica Sur de Guadalajara
Zapopan, Mexico, 45070
Not Yet Recruiting
66
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
Katowice, Poland, 40-600
Not Yet Recruiting
67
IRMED
Piotrkow Trybunalski, Poland, 97-300
Not Yet Recruiting
68
Twoja Przychodnia PCM
Poznan, Poland, 60-324
Not Yet Recruiting
69
Twoja Przychodnia SCM
Szczecin, Poland, 71-434
Not Yet Recruiting
70
WSD MEDI
Warsaw, Poland, 02-786
Not Yet Recruiting
71
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, Poland, 04-501
Not Yet Recruiting
72
ETG Zamość
Zamość, Poland, 22-400
Not Yet Recruiting
73
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Not Yet Recruiting
74
EAP Osona Sud - Alt Congost S.L.P
Centelles, Spain, 08540
Not Yet Recruiting
75
Hospital Universitario Virgen Nieves
Granada, Spain, 18014
Not Yet Recruiting
76
Hospital Clinico San Carlos
Madrid, Spain, 28040
Not Yet Recruiting
77
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Spain, 28222
Not Yet Recruiting
78
Hospital Costa del Sol
Marbella, Spain, 29603
Not Yet Recruiting
79
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, Spain, 37007
Not Yet Recruiting
80
Clínica Gaias - Santiago
Santiago de Compostela, Spain, 15702
Not Yet Recruiting
81
Cheadle Community Hospital
Cheadle, United Kingdom, ST10 1NS
Not Yet Recruiting
82
University Hospital of North Durham
Durham, United Kingdom, DH1 5TW
Not Yet Recruiting
83
HMC Health Group - Meadows Centre for Health
Hounslow, United Kingdom, TW4 7NR
Not Yet Recruiting
84
EMS Healthcare
Macclesfield, United Kingdom, SK10 4TF
Not Yet Recruiting
85
Newquay Health Centre
Newquay, United Kingdom, TR7 1RU
Not Yet Recruiting
86
Woodstock Bower Surgery
Rotherham, United Kingdom, S61 1AH
Not Yet Recruiting
87
Brockwood Medical Practice
Surrey, United Kingdom, RH3 7NJ
Not Yet Recruiting
88
King's Mill Hospital
Sutton in Ashfield, United Kingdom, NG17 4JL
Not Yet Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
P
Physicians interested in becoming principal investigators please contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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