A Study of LY3971297 in Participants With Heart Failure

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Eli Lilly and Company
Study ID
NCT07547540
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • LY3971297 — DRUG
    Administered SC
  • LY3971297 — DRUG
    Administered IV
  • Placebo — DRUG
    Administered SC
  • Placebo — DRUG
    Administered IV

Study Details

The main purpose of this study is to assess how well LY3971297 is tolerated and what side effects may occur in participants with heart failure with preserved ejection fraction (HFpEF) and participants with heart failure with reduced ejection fraction (HFrEF). Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. For each participant, the study will last about 2 months and will include 1 inpatient visit lasting approximately 4 days and 5 outpatient visits.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

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

Arms

  • Experimental: LY3971297 Part A Cohort 1
    LY3971297 administered subcutaneously (SC)
  • Placebo Comparator: Placebo Part A Cohort 1
    Placebo administered SC
  • Experimental: LY3971297 Part A Cohort 2
    LY3971297 administered SC
  • Placebo Comparator: Placebo Part A Cohort 2
    Placebo administered SC
  • Experimental: LY3971297 Part A Cohort 3
    LY3971297 administered SC
  • Placebo Comparator: Placebo Part A Cohort 3
    Placebo administered SC
  • Experimental: LY3971297 Part A Cohort 4
    LY3971297 administered SC
  • Placebo Comparator: Placebo Part A Cohort 4
    Placebo administered SC
  • Experimental: LY3971297 Part A Cohort 5
    LY3971297 administered intravenously (IV)
  • Placebo Comparator: Placebo Part A Cohort 5
    Placebo administered IV
  • Experimental: LY3971297 Part B
    LY3971297 administered SC or IV
  • Placebo Comparator: Placebo Part B
    Placebo administered SC or IV

Primary Outcome Measure

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline through Study Completion (Approximately 2 Months) ]

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 (2)

FacilityCityStateZIPSite coordinators
Washington UniversitySt LouisMissouri63110
Gregory Ewald (PRINCIPAL_INVESTIGATOR)
University of North Carolina, Division of CardiologyChapel HillNorth Carolina27599
919-843-5515
Kirkwood Adams (PRINCIPAL_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Washington University· St Louis, MOUniversity of North Carolina, Division of Cardiology· Chapel Hill, NC

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