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Taking people in United StatesPhase 2

Brenipatide injections for adults with irritable bowel syndrome with constipation

Tests brenipatide, given under the skin, against placebo in adults with IBS-C.

Key facts

Who runs it
Eli Lilly and Company
Where
Anaheim, Columbus, Hollywood, Lancaster, Los Alamitos, Louisville, McAllen, Mesa, New Albany, New York, Providence, San Antonio, Springfield, and Webster, United StatesSee the 14 sitesAlso in 7 other countries, 56 sites
Registry title
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Status
Recruiting
Phase
Phase 2
People taking part
342 people, planned
Started
29 Apr 2026
Expected to end
Sept 2027
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • LY3537031
  • Placebo
Record updated
5 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with irritable bowel syndrome with constipation (IBS-C) who have belly pain. It tests brenipatide (LY3537031), given as an injection under the skin, against placebo.

Age
18 Years to 75 Years
Sex
All sexes can join.
Disease stage
IBS-C by the Rome IV criteria. More than 25% of bowel movements must be hard stools (Bristol Stool Form Scale Types 1 or 2). Less than 25% may be loose stools (Types 6 or 7). Average worst belly pain must be 3.0 or more on a 0-to-10 scale. This is measured in a daily electronic diary over the 14 days in a row before the study treatment is assigned.

Main reasons for not taking part

  • IBS with diarrhea, mixed IBS or unclassified IBS by the Rome IV criteria
  • History of inflammatory or immune-related gut disorders
  • Known important problem with how the stomach empties

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in United States

Also in 7 other countries, 56 sites

  • Smart Cures Clinical ResearchAnaheim, United StatesContact: Dennis Riff (principal investigator)Taking people
  • Ohio GastroenterologyColumbus, United StatesContact: Ryan Gaible (principal investigator)Taking people
  • Encore Medical ResearchHollywood, United StatesContact: Rodolfo Perez (principal investigator)Taking people
  • Om Research LLCLancaster, United StatesContact: Jatinder Pruthi (principal investigator)Taking people
  • United Medical Doctors - Los AlamitosLos Alamitos, United StatesContact: Seyedehsan Navabi (principal investigator)Taking people
  • Gastroenterology Health PartnersLouisville, United StatesContact: Michael Krease (principal investigator)Taking people
  • Biopharma Informatic, LLCMcAllen, United StatesContact: Ralph Alhalel, MD (principal investigator)Taking people
  • Del Sol Research Management - MesaMesa, United StatesContact: David Tessler (principal investigator)Taking people
  • Gastroenterology Health PartnersNew Albany, United StatesContact: Jonathan Obert (principal investigator)Taking people
  • New York Gastroenterology AssociatesNew York, United StatesContact: Yevgenia Pashinsky (principal investigator)Taking people
  • University GastroenterologyProvidence, United StatesContact: Lisa Mueller (principal investigator)Taking people
  • Southern Star Research InstituteSan Antonio, United StatesContact: Jeff Bullock (principal investigator)Taking people
  • Springfield Clinic - FirstSpringfield, United StatesContact: Rajan Kochar (principal investigator)Taking people
  • GI Alliance WebsterWebster, United StatesContact: Sudhanshu Gogia (principal investigator)Taking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

The study will last approximately 36 weeks.

The 2 groups in the trial

  • LY3537031Treatment being tested

    LY3537031 administered subcutaneously (SC).

  • PlaceboPlacebo, for comparison

    Placebo administered SC.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Brenipatide in the Treatment of Adult Participants With IBS-C
Plain-language title
Brenipatide injections for adults with irritable bowel syndrome with constipationGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT07545772, who can take part
Record updated
5 November 2026