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Taking people in United KingdomPhase 2

Brenipatide injections for adults with diarrhea-predominant irritable bowel syndrome

Tests brenipatide against placebo in adults with irritable bowel syndrome with diarrhea.

Key facts

Who runs it
Eli Lilly and Company
Where
Cheadle, Hounslow, Leigh, Newcastle upon Tyne, Newquay, Rotherham, Surrey, and Sutton in Ashfield, United KingdomSee the 8 sitesAlso in 9 other countries, 81 sites
Registry title
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Status
Recruiting
Phase
Phase 2
People taking part
531 people, planned
Started
6 May 2026
Expected to end
Nov 2027
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • LY3537031
  • Placebo
Record updated
4 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 diarrhea (IBS-D). 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-D by the Rome IV criteria. More than 25% of bowel movements are loose or watery (BSFS Types 6 or 7), and <25% are hard (BSFS Types 1 or 2). In the 14 days before the study starts, the average worst belly pain score must be ≥3.0 on a 0-to-10 scale. On at least 4 days per week, the loosest stool must be BSFS ≥5, with at least 2 of those days BSFS ≥6.
Earlier treatment
No major changes in diet in the 4 weeks before screening.

Main reasons for not taking part

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

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Have a history of inflammatory or immune-mediated gastrointestinal disorders
  • Have a diagnosis of IBS with a subtype of constipation, mixed IBS, or unclassified IBS by the Rome IV criteria
  • 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 Kingdom

Also in 9 other countries, 81 sites

  • Cheadle Community HospitalCheadle, United KingdomContact: Mark Stone (principal investigator)Taking people
  • HMC Health Group - Meadows Centre for HealthHounslow, United KingdomContact: Ivor Singh (principal investigator)Taking people
  • EMS HealthcareLeigh, United KingdomContact: Matthew Glaves (principal investigator)Taking people
  • Royal Victoria InfirmaryNewcastle upon Tyne, United KingdomContact: Ashley Price (principal investigator)Taking people
  • Newquay Health CentreNewquay, United KingdomContact: Nicholas Jacobsen (principal investigator)Taking people
  • Woodstock Bower SurgeryRotherham, United KingdomContact: Shahbaz Ali (principal investigator)Taking people
  • Brockwood Medical PracticeSurrey, United KingdomContact: Simone Pereira (principal investigator)Taking people
  • King's Mill HospitalSutton in Ashfield, United KingdomContact: Stephen Foley (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-Diarrhea (IBS-D). 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-D
Plain-language title
Brenipatide injections for adults with diarrhea-predominant irritable bowel syndromeGenerated 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 NCT07545759, who can take part
Record updated
4 November 2026