A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Key facts
- Where
- Sarnia, Scarborough, Stouffville, and Toronto, CanadaSee the 5 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07545772, who can take part
Where in Canada
- Bluewater Clinical Research Group Inc.Sarnia, CanadaContact: John O'Mahony (principal investigator)Taking people
- ClinSurge Research - LMC Scarborough / Malvern Medical CentreScarborough, CanadaContact: Dale Connor (principal investigator)Taking people
- Scarborough Center for Inflammatory Bowel DiseaseScarborough, CanadaContact: Jason Reinglas (principal investigator)Taking people
- Stouffville Medical Research Institute Inc.Stouffville, CanadaContact: Nima Mirtorabi (principal investigator)Taking people
- Canadian Phase OnwardToronto, CanadaContact: Leslie Housefather (principal investigator)Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07545772EU 2025-524974-41-00
- Record updated
- 5 November 2026
- Original description
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.Read full original descriptionShow less
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Brenipatide in the Treatment of Adult Participants With IBS-C
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 36 weeks.
Inclusion: 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; 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.
Exclusion: 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.