Irritable Bowel Syndrome Constipation
Conditions
Interventions
DRUG: LY3537031(Other Name: Brenipatide)
Administered SC.
DRUG: Placebo
Administered SC.
(Study Arms)
Experimental: LY3537031
LY3537031 administered subcutaneously (SC).
Interventions:
Dr
Sponsors
Masaki Takeshi
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with a Weekly Composite Clinical Response for at Least 50 Percent (%) of Weeks [Time Frame: Week 9 to 16] | — |
Countries
Japan, United States
Contacts
Public ContactTrial Guide Call Center
Eli Lilly Japan K.K.
Outcome results
None listed