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
- Cheadle, Hounslow, Leigh, Newcastle upon Tyne, Newquay, Rotherham, Surrey, and Sutton in Ashfield, United KingdomSee the 8 sitesAlso in 7 other countries, 62 sites
- Trial code
- 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 Kingdom
Also in 7 other countries, 62 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-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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData 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