A Study of LY3971297 in Participants With Heart Failure
Part of paid clinical trials in Detroit, Michigan.
- Sponsor
- Eli Lilly and Company
- Study ID
- NCT07547540
- Phase
- PHASE1
- Status
- Not Yet Recruiting
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Conditions
- Heart Failure
- Heart Failure, Diastolic
- Heart Failure, Systolic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
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
- First listed
- Apr 23, 2026
- Start date
- Aug 31, 2026
- Status verified
- Aug 2026
- Primary completion
- Nov 30, 2027
- Completion
- Nov 30, 2027
Study Design
- Enrollment
- 90 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: LY3971297 Part A Cohort 1LY3971297 administered subcutaneously (SC)
- Placebo Comparator: Placebo Part A Cohort 1Placebo administered SC
- Experimental: LY3971297 Part A Cohort 2LY3971297 administered SC
- Placebo Comparator: Placebo Part A Cohort 2Placebo administered SC
- Experimental: LY3971297 Part A Cohort 3LY3971297 administered SC
- Placebo Comparator: Placebo Part A Cohort 3Placebo administered SC
- Experimental: LY3971297 Part A Cohort 4LY3971297 administered SC
- Placebo Comparator: Placebo Part A Cohort 4Placebo administered SC
- Experimental: LY3971297 Part A Cohort 5LY3971297 administered intravenously (IV)
- Placebo Comparator: Placebo Part A Cohort 5Placebo administered IV
- Experimental: LY3971297 Part BLY3971297 administered SC or IV
- Placebo Comparator: Placebo Part BPlacebo 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) or1-317-615-4559
- Physicians interested in becoming principal investigators please contact
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | 313-916-6375 David Lanfear (PRINCIPAL_INVESTIGATOR) |
| Washington University | St Louis | Missouri | 63110 | 314-454-7009 Gregory Ewald (PRINCIPAL_INVESTIGATOR) |
| University of North Carolina, Division of Cardiology | Chapel Hill | North Carolina | 27599 | 919-843-9937 Kirkwood Adams (PRINCIPAL_INVESTIGATOR) |
| Houston Methodist Hospital | Houston | Texas | 77030 | Mahwash Kassi (PRINCIPAL_INVESTIGATOR) |
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