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

Part of paid clinical trials in Mesa, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT07545759
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Diarrhea
  • Irritable Bowel Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • LY3537031 — DRUG
    Administered SC
  • Placebo — DRUG
    Administered SC

Study Details

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.

Key Dates

Start date
May 6, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
531 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LY3537031
    LY3537031 administered subcutaneously (SC)
  • Placebo Comparator: Placebo
    Placebo administered SC

Primary Outcome Measure

Percentage of Participants Who Had a Daily Composite Response for at Least 50 Percent (%) of Days [ Time Frame: Week 9 to Week 16 ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (14)

FacilityCityStateZIPSite coordinators
Del Sol Research Management - MesaMesaArizona85206
520-257-3881
David Tessler (PRINCIPAL_INVESTIGATOR)
Smart Cures Clinical ResearchAnaheimCalifornia92806
Dennis Riff (PRINCIPAL_INVESTIGATOR)
Om Research LLCLancasterCalifornia93534
6613882239
Jatinder Pruthi (PRINCIPAL_INVESTIGATOR)
United Medical Doctors - Los AlamitosLos AlamitosCalifornia90720
5624304449
Seyedehsan Navabi (PRINCIPAL_INVESTIGATOR)
Encore Medical ResearchHollywoodFlorida33024
9544001725
Rodolfo Perez (PRINCIPAL_INVESTIGATOR)
Clinical Research of OsceolaKissimmeeFlorida34741
4079544016
Basher Atiquzzaman (PRINCIPAL_INVESTIGATOR)
Springfield Clinic - FirstSpringfieldIllinois62702
2175287541
Rajan Kochar (PRINCIPAL_INVESTIGATOR)
Gastroenterology Health PartnersNew AlbanyIndiana47150
812-206-1702
Jonathan Obert (PRINCIPAL_INVESTIGATOR)
Gastroenterology Health PartnersLouisvilleKentucky40218
5028881988
Michael Krease (PRINCIPAL_INVESTIGATOR)
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research CenterWyomingMichigan49519
Allan Coates (PRINCIPAL_INVESTIGATOR)
Ohio GastroenterologyColumbusOhio43202
614-754-5500
Ryan Gaible (PRINCIPAL_INVESTIGATOR)
University GastroenterologyProvidenceRhode Island02905
401-421-8800
Lisa Mueller (PRINCIPAL_INVESTIGATOR)
Biopharma Informatic, LLCMcAllenTexas78503
(281) 944-3610
Ralph Alhalel, MD (PRINCIPAL_INVESTIGATOR)
Southern Star Research InstituteSan AntonioTexas78229
210-581-2812
Jeff Bullock (PRINCIPAL_INVESTIGATOR)

Find similar trials in Mesa, AZ

By research site
Del Sol Research Management - Mesa· Mesa, AZSmart Cures Clinical Research· Anaheim, CAOm Research LLC· Lancaster, CAUnited Medical Doctors - Los Alamitos· Los Alamitos, CAEncore Medical Research· Hollywood, FLClinical Research of Osceola· Kissimmee, FL

Related Studies