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

• LY3537031 (Drug), also known as Brenipatide: Administered SC.
• Placebo (Drug): Administered SC.

Primary outcomes

• Percentage of Participants with a Weekly Composite Clinical Response for at Least 50 Percent (%) of Weeks [Week 9 to 16]

Secondary outcomes

• Percentage of Participants with a Weekly Abdominal Pain Response for at Least 50% of Weeks [Week 9 to 16]
• Percentage of Participants with a Weekly Complete Spontaneous Bowel Movement (CSBM) for at Least 50% of Weeks [Week 9 to 16]

Sex: All, ages: 18 Years to 75 Years

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

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company

NIH grants: 2025