531 Participants NeededMy employer runs this trial

Brenipatide for Irritable Bowel Syndrome

(RENEW-IBS-D Trial)

Recruiting at 87 trial locations
Pi
Tq
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 for individuals with Irritable Bowel Syndrome-Diarrhea (IBS-D). The researchers aim to evaluate the treatment's effectiveness, potential side effects, and safety compared to a placebo (a harmless, inactive substance). Participants will receive the treatment via subcutaneous injection, and the study will last about 35 weeks. The trial seeks individuals who frequently experience diarrhea and abdominal pain that disrupts daily life, without recent major diet changes. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in IBS-D treatment.

Do I have to stop taking 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 shows that brenipatide is currently being tested for safety and tolerability in individuals with Irritable Bowel Syndrome-Diarrhea (IBS-D). Early results suggest that most participants tolerate brenipatide well. However, researchers continue to study specific side effects in ongoing trials. Since this trial is in Phase 2, earlier studies have indicated that brenipatide is somewhat safe for humans, but more information is needed to understand all possible side effects. Participants have not reported any serious side effects, though mild to moderate ones may occur. Always consult the trial team about potential risks to receive the most accurate and personalized information.12345

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

Unlike the standard treatments for irritable bowel syndrome (IBS), such as antispasmodics and dietary changes, Brenipatide offers a novel approach by being administered subcutaneously. This method might provide more consistent and targeted delivery of the medication, potentially improving effectiveness. Additionally, Brenipatide may work through a unique mechanism that sets it apart from current options, which often focus on symptomatic relief rather than addressing underlying causes. Researchers are excited about Brenipatide because it promises a new way to manage IBS symptoms, potentially offering relief to patients who haven't found success with existing therapies.

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

Research has shown that brenipatide is under investigation as a potential treatment for individuals with irritable bowel syndrome with diarrhea (IBS-D). In this trial, participants will receive either brenipatide or a placebo. Early findings suggest that brenipatide might help reduce symptoms such as frequent diarrhea and stomach pain, which are common in IBS-D. Although research continues, initial results appear promising for enhancing patients' daily lives. Brenipatide targets specific processes in the gut to manage these uncomfortable symptoms. However, further studies are necessary to fully understand its benefits and safety.12467

Who Is on the Research Team?

C1

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 adults with irritable bowel syndrome with diarrhea (IBS-D) who have frequent loose stools and moderate abdominal pain, haven't changed their diet recently, and meet specific stool pattern criteria. People with other major digestive issues or recent big dietary changes can't join.

Inclusion Criteria

Do you have belly pain along with frequent loose or watery 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 in people with IBS-D. The goal is to see how safe it is and if it helps symptoms 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 Study of Brenipatide (LY3537031) in Participants ... - MedPath

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 ...

Brenipatide for Irritable Bowel Syndrome · Info for Participants

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 ...

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 ...