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

Lilly

Status and phase: Enrolling; Phase 2

Conditions: Irritable Bowel Syndrome; Constipation

Treatments: Drug: LY3537031; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07545772

J2S-MC-GZMT (Other Identifier)

27821

2025-524974-41-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 342 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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342 participants in 2 patient groups, including a placebo group

LY3537031

Experimental group

Description:

LY3537031 administered subcutaneously (SC).

Treatment:

Drug: LY3537031

Placebo

Placebo Comparator group

Description:

Placebo administered SC.

Treatment:

Drug: Placebo