RENEW-IBS-C

RecruitingPhase 2

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

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

Lead sponsor

Eli Lilly and Company

Asset

Brenipatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Estimated enrollment

342

Study population

Constipation, Irritable Bowel Syndrome

Eligibility highlights

Primary endpoint

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

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 IDNCT07545772

Org study ID27821

Secondary ID2025

Secondary ID2025-524974-41-00

Secondary IDJ2S-MC-GZMTEli Lilly and Company

Timeline

Milestones

Study first posted2026-04-22actual

Study start2026-04-29actual

Last update posted2026-11-05actual

Primary completion2027-07estimated (month precision)

Study completion2027-09estimated (month precision)

Assets

Investigational agents

Brenipatide

Who this study enrolls

ConstipationIrritable Bowel Syndrome

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (3)

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)

3 endpoints

Primary/protocol endpoint/low confidence

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

Time frame:Week 9 to 16

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Percentage of Participants with a Weekly Abdominal Pain Response for at Least 50% of Weeks

Time frame:Week 9 to 16

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Percentage of Participants with a Weekly Complete Spontaneous Bowel Movement (CSBM) for at Least 50% of Weeks

Time frame:Week 9 to 16

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.