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

ClinicalTrials.gov ID

NCT07545772

Lead Sponsor

Eli Lilly and CompanyINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

342Estimated

Last Update Posted

Sep 8, 2026Actual

Start Date

Apr 29, 2026Actual

Primary Completion Date

Jul 2027Estimated

Completion Date

Sep 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-C

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.

• Irritable Bowel Syndrome
• Constipation

• 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:

• 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

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

81120023812

81120023812

81120023812

81120023812

2299327808

+349133000

686487983

0034881850285

07452948414

0151 350 1590

01637 850002

07551985998

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