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

Lilly

Status and phase: Not yet enrolling; Phase 2

Conditions: Irritable Bowel Syndrome; Diarrhea

Treatments: Drug: LY3537031; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07545759

27805

J2S-MC-GZMS (Other Identifier)

2025-524973-17-00 (Other Identifier)

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-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.

Enrollment: 531 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

531 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