At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- LY3537031 (drug), Placebo (drug)
- How long the study runs
- Study runs about 18 months (dates as stated)
- About the drug or intervention
- LY3537031 — drug: Administered SC · Placebo — drug: Administered SC
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 75 Years
- Who
- All
- Number of participants
- 531
- Started
- 2026-05-06
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for irritable bowel syndrome
- • Phase2 - 531 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 participants with Irritable Bowel Syndrome-Diarrhea (IBS-D)
Who can take part?
- • Ages 18 Years to 75 Years
- • Diagnosed with irritable bowel syndrome
Where?
- • Cheadle - Cheadle Community Hospital
- • Hounslow - HMC Health Group - Meadows Centre for Health
- • Macclesfield - EMS Healthcare
- • Newcastle upon Tyne - Royal Victoria Infirmary
- • +4 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This 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 participants with Irritable Bowel Syndrome-Diarrhea (IBS-D). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo. The study will last approximately 36 weeks.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 75 Years
- Who can join: All genders
What the study is looking for
- ✓Meet Rome IV criteria for IBS-D, which includes having greater than 25% of bowel movements with Bristol Stool Form...
- ✓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...
- ✓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...
- ✓Have had no major changes in diet in the 4 weeks prior to screening
Who cannot take part
- ✗Have a diagnosis of IBS with a subtype of constipation, 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
See the full criteria
Where Is This Study? (8 UK sites)
Cheadle Community Hospital
Cheadle ST10 1NS, United Kingdom
HMC Health Group - Meadows Centre for Health
Hounslow TW4 7NJ, United Kingdom
EMS Healthcare
Macclesfield SK10 4TF, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne NE1 4LP, United Kingdom
Newquay Health Centre
Newquay TR7 1RU, United Kingdom
Woodstock Bower Surgery
Rotherham S61 1AH, United Kingdom
Brockwood Medical Practice
Surrey RH3 7NJ, United Kingdom
King's Mill Hospital
Sutton in Ashfield NG17 4JL, United Kingdom
How to Get in Touch
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Sponsor contactCONTACT
Physicians interested in becoming principal investigators please contact
Sponsor contactCONTACT