A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Key facts
- Where
- Binzhou, Chengdu, Guangzhou, Hangzhou, Hengyang, Huizhou, Huzhou, Meihekou, Quzhou, Taian, Xianning, and Yichun, ChinaSee the 12 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: NCT07545759, who can take part
Where in China
- Binzhou Medical University HospitalBinzhou, ChinaContact: Ning Shi (principal investigator)Taking people
- Sichuan Provincial People's HospitalChengdu, ChinaContact: Chao Zhou (principal investigator)Taking people
- The First Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, ChinaContact: Yinglian Xiao (principal investigator)Taking people
- Zhejiang Hospital of Traditioal Chinese MedicineHangzhou, ChinaContact: Bin Lv (principal investigator)Taking people
- The Second Affiliated Hospital of University of South ChinaHengyang, ChinaContact: Honghui Chen (principal investigator)Taking people
- Huizhou Central People's HospitalHuizhou, ChinaContact: Huixin Chen (principal investigator)Taking people
- Huzhou Central HospitalHuzhou, ChinaContact: Wei Wu (principal investigator)Taking people
- Meihekou Central HospitalMeihekou, ChinaContact: Zhongwei Pan (principal investigator)Taking people
- Quzhou people's HospitalQuzhou, ChinaContact: Jianguang Xu (principal investigator)Taking people
- Taian City Central HospitalTaian, ChinaContact: Haipeng Yuan (principal investigator)Taking people
- Xianning Central HospitalXianning, ChinaContact: Jianguang Xiong (principal investigator)Taking people
- Yichun People's HospitalYichun, ChinaContact: Huizhen Fan (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
- NCT07545759EU 2025-524973-17-00
- Record updated
- 4 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-Diarrhea (IBS-D). 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-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 36 weeks.
Inclusion: 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.
Exclusion: Have a history of inflammatory or immune-mediated gastrointestinal disorders; Have a diagnosis of IBS with a subtype of constipation, mixed IBS, or unclassified IBS by the Rome IV criteria; Have a known clinically significant gastric emptying abnormality.