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
Eli Lilly and Company
Summary
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 35 weeks.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- DrugLY3537031
Administered SC
- DrugPlacebo
Administered SC
Locations (88)
- Del Sol Research Management - MesaMesa, Arizona
- Smart Cures Clinical ResearchAnaheim, California
- Om Research LLCLancaster, California
- United Medical Doctors - Los AlamitosLos Alamitos, California
- Encore Medical ResearchHollywood, Florida
- Clinical Research of OsceolaKissimmee, Florida