NCT07545772

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
342

participants targeted

Target at P75+ for phase_2

Timeline
16mo left

Started Apr 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Apr 2026Sep 2027

Study Start

First participant enrolled

April 1, 2026

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

April 16, 2026

Last Update Submit

April 16, 2026

Conditions

Irritable Bowel SyndromeConstipation

Outcome Measures

Primary Outcomes (1)

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

    Week 9 to 16

Secondary Outcomes (2)

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

    Week 9 to 16

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

    Week 9 to 16

Study Arms (2)

LY3537031

EXPERIMENTAL

LY3537031 administered subcutaneously (SC).

Drug: LY3537031

Placebo

PLACEBO COMPARATOR

Placebo administered SC.

Drug: Placebo

Interventions

LY3537031DRUG

Administered SC.

Also known as: Brenipatide
LY3537031
PlaceboDRUG

Administered SC.

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastroenterology Health Partners Loc. 1

Louisville, Kentucky, 40218, United States

Location

MeSH Terms

Conditions

Irritable Bowel SyndromeConstipation

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2026

First Posted

April 22, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
More information

Locations

US(1)