A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)

Purpose

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.

Conditions

  • Irritable Bowel Syndrome
  • Diarrhea

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts 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 - Have had no major changes in diet in the 4 weeks prior to screening

Exclusion Criteria

  • 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LY3537031 		LY3537031 administered subcutaneously (SC)
  • Drug: LY3537031
    Administered SC
    Other names:
    • Brenipatide
Placebo Comparator
Placebo 		Placebo administered SC
  • Drug: Placebo
    Administered SC

Recruiting Locations

Del Sol Research Management - Mesa
Mesa, Arizona 85206
Contact:
520-257-3881

Smart Cures Clinical Research
Anaheim, California 92806

Om Research LLC
Lancaster, California 93534
Contact:
661-388-2239

United Medical Doctors - Los Alamitos
Los Alamitos, California 90720
Contact:
562-430-4449

Encore Medical Research
Hollywood, Florida 33024
Contact:
954-400-1725

Clinical Research of Osceola
Kissimmee, Florida 34741
Contact:
407-954-4016

Springfield Clinic - First
Springfield, Illinois 62702
Contact:
217-528-7541

Gastroenterology Health Partners
New Albany, Indiana 47150
Contact:
812-206-1702

Gastroenterology Health Partners
Louisville, Kentucky 40218
Contact:
502-888-1988

Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
Wyoming, Michigan 49519

Ohio Gastroenterology
Columbus, Ohio 43202
Contact:
614-754-5500

University Gastroenterology
Providence, Rhode Island 02905
Contact:
401-421-8800

Biopharma Informatic, LLC
McAllen, Texas 78503
Contact:
281-944-3610

Southern Star Research Institute
San Antonio, Texas 78229
Contact:
210-581-2812

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com