NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Irritable Bowel Syndrome Constipation
Date of first enrollment	15/06/2026
Target sample size	342
Countries of recruitment	United States,Japan
Study type	Interventional
Intervention(s)	DRUG: LY3537031(Other Name: Brenipatide) Administered SC. DRUG: Placebo Administered SC. (Study Arms) Experimental: LY3537031 LY3537031 administered subcutaneously (SC). Interventions: Drug: LY3537031 Placebo Comparator: Placebo Placebo administered SC. Interventions: Drug: Placebo

Outcome(s)

Primary Outcome	Percentage of Participants with a Weekly Composite Clinical Response for at Least 50 Percent (%) of Weeks [Time Frame: Week 9 to 16]
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 75age old
Gender	Both
Include 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
Exclude 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