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

ClinicalTrials.gov ID

NCT07545759

Lead Sponsor

Eli Lilly and CompanyINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

531Estimated

Last Update Posted

Sep 8, 2026Actual

Start Date

May 6, 2026Actual

Primary Completion Date

Sep 2027Estimated

Completion Date

Nov 2027Estimated

Official Title

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

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.

• Irritable Bowel Syndrome
• Diarrhea

• LY3537031
• Placebo

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Eli Lilly and CompanyINDUSTRY

661-388-2239

954-400-1725

614-754-5500

281-944-3610

003232852814

+3250365155

+3224776811

03 821 30 00

+3292467100

092245335

093325166

+3216344225

+3243554211

+32 51 23 72 15

030 3101360

004981316119311

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81120023812

81120023812

81120023812

81120023812

81120023812

+48 724 444 299

48 91 433 29 19

+48 504 440 092

48606930022

+349133000

686487983

0034881850285

07452948414

0151 350 1590

01637 850002

07551985998

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