A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)

Part of paid clinical trials in Mesa, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT07545772
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Constipation
  • 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-Constipation (IBS-C). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo. The study will last approximately 35 weeks.

Key Dates

First listed
Apr 22, 2026
Start date
Apr 29, 2026
Status verified
Aug 2026
Primary completion
Jul 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
342 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 with a Weekly Composite Clinical Response for at Least 50 Percent (%) of Weeks [ Time Frame: Week 9 to 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
661-388-2239
Jatinder Pruthi (PRINCIPAL_INVESTIGATOR)
United Medical Doctors - Los AlamitosLos AlamitosCalifornia90720
562-430-4449
Seyedehsan Navabi (PRINCIPAL_INVESTIGATOR)
Encore Medical ResearchHollywoodFlorida33024
954-400-1725
Rodolfo Perez (PRINCIPAL_INVESTIGATOR)
Springfield Clinic - FirstSpringfieldIllinois62702
217-528-7541
Rajan Kochar (PRINCIPAL_INVESTIGATOR)
Gastroenterology Health PartnersNew AlbanyIndiana47150
812-206-1702
Jonathan Obert (PRINCIPAL_INVESTIGATOR)
Gastroenterology Health PartnersLouisvilleKentucky40218
502-888-1988
Michael Krease (PRINCIPAL_INVESTIGATOR)
New York Gastroenterology AssociatesNew YorkNew York10075
212-535-1845
Yevgenia Pashinsky (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)
GI Alliance-WebsterWebsterTexas77598
Sudhanshu Gogia (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, FLSpringfield Clinic - First· Springfield, IL

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