Last updated 5 days ago
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
531 patients around the world
Available in United States, Mexico
Eli Lilly and Company
7Research sites
531Patients around the world
This study is for people with
Irritable bowel syndrome
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- 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 less than 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.
- 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.
Sites
Köhler & Milstein Research
CIMAB S.A. de C.V. - Coahuila
Centro de Investigación Clínica Chapultepec - Sanatorio La Luz
Scientia Investigacion Clinica S.C.
Clinical Research Institute S.C.
Hospital Juarez de México
Clínica de Investigación en Reumatología y Obesidad S.C.
StudyRENEW-IBS-D
SponsorEli Lilly and Company
Study typeInterventional
Conditions
Irritable bowel syndrome
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07545759
