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

Part of paid clinical trials in Louisville, Kentucky.

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

Start date
Apr 29, 2026
Status verified
Apr 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 (1)

FacilityCityStateZIPSite coordinators
Gastroenterology Health Partners Loc. 1LouisvilleKentucky40218
502-888-1988

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Gastroenterology Health Partners Loc. 1· Louisville, KY

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