Actively Recruiting
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Brenipatide in Adults With Irritable Bowel Syndrome-Constipation (IBS-C)
Led by Eli Lilly and Company · Updated on 2026-05-13
342
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, side effects, and effectiveness of brenipatide (LY3537031) in adults with Irritable Bowel Syndrome-Constipation (IBS-C). This study compares brenipatide given as a subcutaneous injection with a placebo to better understand how well the drug is tolerated and its impact on IBS-C symptoms. The trial is a phase 2, randomized, double-blind, placebo-controlled study sponsored by Eli Lilly and Company. Participants will receive either brenipatide or a placebo, both administered by subcutaneous injection. The study is expected to last about 35 weeks. Researchers will monitor participants closely to assess their response to the treatment during this period. Throughout the study, participants will be asked to record symptoms such as abdominal pain and bowel movements using a daily electronic diary. The main outcome measured is the percentage of participants showing a weekly clinical response over weeks 9 to 16. Secondary outcomes include weekly abdominal pain and complete spontaneous bowel movement responses during the same timeframe. Safety and side effects will also be carefully monitored during the study period.
CONDITIONS
Brief Title
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Meet Rome IV criteria for irritable bowel syndrome-constipation (IBS-C)
- Have more than 25% bowel movements with Bristol Stool Form Scale (BSFS) Types 1 or 2 and less than 25% with Types 6 or 7
- Average worst abdominal pain score of 3 or higher on a 0-to-10 scale during 14 consecutive days before randomization based on daily eDiary
You will not qualify if you...
- Diagnosis of IBS with diarrhea subtype, mixed IBS, or unclassified IBS
- History of inflammatory or immune-mediated gastrointestinal disorders
- Known clinically significant gastric emptying abnormality
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive subcutaneous injections of either Brenipatide (LY3537031) or placebo as part of the study treatment.
Weekly visits for up to 8 weeks
Trial Site Locations
Total: 1 location
1
Gastroenterology Health Partners Loc. 1
Louisville, Kentucky, United States, 40218
Actively Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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