Do you have Irritable Bowel Syndrome-Diarrhea (IBS-D)?
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.
Would you like to take part?
As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow up of your condition to monitor the safety and effectiveness of the care you’ll receive. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study 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
- 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
You may not qualify to participate in this study if you:
- 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
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.
