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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)

NCT07545759

RecruitingPhase 2

Sponsor: Eli Lilly and Company

Conditions: Irritable Bowel Syndrome, Diarrhea

Interventions: LY3537031, Placebo

Countries: United States, Belgium, Canada, China, Germany, Japan, Mexico, Poland

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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
Locations (89)
  • Mesa, Arizona, United States
  • Anaheim, California, United States
  • Lancaster, California, United States
  • Los Alamitos, California, United States
  • Hollywood, Florida, United States
  • Kissimmee, Florida, United States
  • Springfield, Illinois, United States
  • New Albany, Indiana, United States
  • Louisville, Kentucky, United States
  • Wyoming, Michigan, United States
  • Rochester, Minnesota, United States
  • Columbus, Ohio, United States
  • Providence, Rhode Island, United States
  • McAllen, Texas, United States
  • San Antonio, Texas, United States
  • Antwerp, Belgium
  • Bruges, Belgium
  • Brussels, Belgium
  • Edegem, Belgium
  • Ghent, Belgium
  • Ghent, Belgium
  • Ghent, Belgium
  • Leuven, Belgium
  • Liège, Belgium
  • Roeselare, Belgium
  • Sarnia, Canada
  • Scarborough, Canada
  • Scarborough, Canada
  • Stouffville, Canada
  • Toronto, Canada
  • + 59 more on CT.gov