A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
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-Constipation (IBS-C). 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
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
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
Disqualifiers
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 design
Treatments tested in this trial
- LY3537031
- Placebo
Treatment groups
342 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov