342 Participants NeededMy employer runs this trial

Brenipatide for IBS-C

(RENEW-IBS-C Trial)

Recruiting at 68 trial locations
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Overseen ByTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Eli Lilly and Company
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called brenipatide to evaluate its effectiveness and safety for individuals with Irritable Bowel Syndrome-Constipation (IBS-C). Participants will receive either brenipatide or a placebo via a small injection under the skin. The trial aims to assess the treatment's impact on symptoms such as infrequent bowel movements and abdominal pain. Individuals who regularly experience constipation and abdominal pain, particularly with hard or lumpy bowel movements, may be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that brenipatide is likely to be safe for humans?

Research has shown that brenipatide is usually well-tolerated by people with Irritable Bowel Syndrome with Constipation (IBS-C). Previous studies identified diarrhea as the most common side effect. Other side effects were rarely reported, suggesting they might be less common or less serious. This medication remains under investigation, making ongoing trials like this one crucial. They help identify any new side effects and confirm the treatment's safety.12345

Why do researchers think this study treatment might be promising for IBS-C?

Brenipatide for IBS-C is unique because it introduces a new approach with its active ingredient, LY3537031, which is administered subcutaneously. Unlike traditional IBS-C treatments that often focus on altering gut motility or increasing fluid secretion in the intestines, Brenipatide targets specific pathways differently. Researchers are excited about its potential to provide relief with fewer side effects and more convenient dosing compared to oral medications, which are the standard treatments. This could mean a more effective and patient-friendly option for managing IBS-C symptoms.

What evidence suggests that brenipatide might be an effective treatment for IBS-C?

Research has shown that brenipatide might help ease symptoms of Irritable Bowel Syndrome with Constipation (IBS-C). Early results indicate that patients experienced less abdominal pain and improved bowel movements. One study revealed that participants had a noticeable decrease in symptoms compared to those who took a placebo. This trial will compare brenipatide, administered subcutaneously, with a placebo to further evaluate its effectiveness and safety in managing IBS-C symptoms. However, more research is needed to confirm these findings and ensure its overall safety and effectiveness.12346

Who Is on the Research Team?

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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)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for people diagnosed with irritable bowel syndrome with constipation (IBS-C), who have mostly hard or lumpy stools and regular abdominal pain. Participants should meet specific symptom criteria before joining.

Inclusion Criteria

Do you have belly pain along with hard or lumpy stools?

Exclusion Criteria

Do you have a known problem with your stomach emptying food too slowly?
Do you have an inflammatory bowel disease or immune-related digestive disorder?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive brenipatide or placebo administered subcutaneously

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Brenipatide

Trial Overview

The study compares a new drug called brenipatide (LY3537031), given as an injection under the skin, to a placebo. The goal is to see how safe and effective brenipatide is for treating IBS-C over about 35 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: LY3537031Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

A Study of Brenipatide (LY3537031) in Participants With ...

The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated what side effects may occur, and the safety and efficacy ...

A Study of Brenipatide (LY3537031) in Participants With ...

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 ...

A clinical trial for people who have irritable bowel syndrome ...

GZMT will test an investigational medicine called brenipatide. The study will test if it is safe and can help reduce IBS-C symptoms.

Brenipatide for IBS-C (RENEW-IBS-C Trial)

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 ...

A Study of Brenipatide (LY3537031) in Participants With ...

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 ...

A Study of Brenipatide (LY3537031) in Participants With ...

The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated, what side effects may occur, and the safety and efficacy ...