A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEli Lilly and Company
About this trial
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.
Eligibility criteria
Qualifiers
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 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
Disqualifiers
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
Trial design
Treatments tested in this trial
- LY3537031
- Placebo
Treatment groups
531 Participants
are divided into 2 treatment groupsLocations
88Belgium
Sint Vincentius Ziekenhuis2018, Antwerp Belgium
AZ Sint-Lucas8310, Bruges Belgium
UZ Brussel1090, Brussels Belgium
Antwerp University Hospital2650, Edegem Belgium
Sponsors and collaborators
Eli Lilly and Company
Lead sponsor
Source ClinicalTrials.gov