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Clinical Trials/NCT07545772
NCT07545772
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-C

Eli Lilly and Company1 site in 1 country342 target enrollmentStarted: April 1, 2026Last updated:
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ConditionsIrritable Bowel SyndromeConstipation
InterventionsPlaceboLY3537031
DrugsLY3537031Placebo

Overview

Phase
Phase 2
Status
Not yet recruiting
Enrollment
342
Locations
1
Primary Endpoint
Percentage of Participants with a Weekly Composite Clinical Response for at Least 50 Percent (%) of Weeks
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-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.

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

  • •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

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 with a Weekly Composite Clinical Response for at Least 50 Percent (%) of Weeks

Time Frame: 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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