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Clinical Trials/NCT07545759
NCT07545759
Not yet recruiting
Phase 2

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Brenipatide in the Treatment of Adult Participants With IBS-D

Eli Lilly and Company88 sites in 6 countries531 target enrollmentStarted: April 1, 2026Last updated:
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ConditionsIrritable Bowel SyndromeDiarrhea
InterventionsPlaceboLY3537031
DrugsLY3537031Placebo

Overview

Phase
Phase 2
Status
Not yet recruiting
Enrollment
531
Locations
88
Primary Endpoint
Percentage of Participants Who Had a Daily Composite Response for at Least 50 Percent (%) of Days
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Placebo

Placebo Comparator

Placebo administered SC

Intervention: Placebo (Drug)

LY3537031

Experimental

LY3537031 administered subcutaneously (SC)

Intervention: LY3537031 (Drug)

Outcomes

Primary Outcomes

Percentage of Participants Who Had a Daily Composite Response for at Least 50 Percent (%) of Days

Time Frame: Week 9 to Week 16

Secondary Outcomes

  • Percentage of Participants Who Had a Daily Abdominal Pain Response for at Least 50% of Days(Week 9 to Week 16)
  • Percentage of Participants Who Had Daily Stool Consistency Response for at Least 50% of Days(Week 1 to Week 24)
  • Percentage of Participants Who Had a Daily Composite Response(Day 1 through Week 24)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (88)

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