RENEW-IBS-D

RecruitingPhase 2

A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)

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

Lead sponsor

Eli Lilly and Company

Asset

Brenipatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Estimated enrollment

531

Study population

Diarrhea, Irritable Bowel Syndrome

Eligibility highlights

Primary endpoint

•Percentage of Participants Who Had a Daily Composite Response for at Least 50

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07545759

Org study ID27805

Secondary ID2025

Secondary ID2025-524973-17-00EU Trial (CTIS) Number

Secondary IDJ2S-MC-GZMSEli Lilly and Company

Timeline

Milestones

Study first posted2026-04-22actual

Study start2026-05-06actual

Last update posted2026-11-04actual

Primary completion2027-09estimated (month precision)

Study completion2027-11estimated (month precision)

Assets

Investigational agents

Brenipatide

Who this study enrolls

DiarrheaIrritable Bowel Syndrome

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other (unclassified)

4 endpoints

Primary/protocol endpoint/low confidence

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

Time frame:Week 9 to Week 16

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Percentage of Participants Who Had a Daily Abdominal Pain Response for at Least 50% of Days

Time frame:Week 9 to Week 16

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Percentage of Participants Who Had Daily Stool Consistency Response for at Least 50% of Days

Time frame:Week 1 to Week 24

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Percentage of Participants Who Had a Daily Composite Response

Time frame:Day 1 through Week 24

threshold achievement, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.