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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)

NCT07545772

RecruitingPhase 2

Sponsor: Eli Lilly and Company

Conditions: Irritable Bowel Syndrome, Constipation

Interventions: LY3537031, Placebo

Countries: United States, Belgium, Canada, China, Japan, Mexico, Spain, United Kingdom

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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
Locations (70)
  • Mesa, Arizona, United States
  • Anaheim, California, United States
  • Lancaster, California, United States
  • Los Alamitos, California, United States
  • Hollywood, Florida, United States
  • Springfield, Illinois, United States
  • New Albany, Indiana, United States
  • Louisville, Kentucky, United States
  • New York, New York, United States
  • Columbus, Ohio, United States
  • Providence, Rhode Island, United States
  • McAllen, Texas, United States
  • San Antonio, Texas, United States
  • Webster, 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
  • Binzhou, China
  • + 40 more on CT.gov