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LY3971297

Phase 1

Heart Failure | Small molecule | Cardiovascular |Eli Lilly and Company|Last Updated: May 22, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment90
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07547540A Study of LY3971297 in Participants With Heart FailurePHASE1 NOT YET_RECRUITING 90Jun 1, 2026Aug 1, 2027May 22, 20263 United States, Japan
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Study Endpoints
Primary Endpoints
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline through Study Completion (Approximately 2 Months)
Number of Participants with One or More Treatment-Emergent Adverse Event
Baseline through Study Completion (Approximately 2 Months)
Secondary Endpoints
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3971297
Predose on Day 1 up to Day 29 Post-Dose
PK: Maximum Concentration (Cmax) of LY3971297
Predose on Day 1 up to Day 29 Post-Dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY3971297 Part A Cohort 1EXPERIMENTALLY3971297 administered subcutaneously (SC)
Placebo Part A Cohort 1PLACEBO_COMPARATORPlacebo administered SC
LY3971297 Part A Cohort 2EXPERIMENTALLY3971297 administered SC
Placebo Part A Cohort 2PLACEBO_COMPARATORPlacebo administered SC
LY3971297 Part A Cohort 3EXPERIMENTALLY3971297 administered SC
Placebo Part A Cohort 3PLACEBO_COMPARATORPlacebo administered SC
LY3971297 Part A Cohort 4EXPERIMENTALLY3971297 administered SC
Placebo Part A Cohort 4PLACEBO_COMPARATORPlacebo administered SC
LY3971297 Part A Cohort 5EXPERIMENTALLY3971297 administered intravenously (IV)
Placebo Part A Cohort 5PLACEBO_COMPARATORPlacebo administered IV
LY3971297 Part BEXPERIMENTALLY3971297 administered SC or IV
Placebo Part BPLACEBO_COMPARATORPlacebo administered SC or IV
Interventions
NameTypeDescription
LY3971297DRUGAdministered SC
PlaceboDRUGAdministered SC
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Are diagnosed with chronic heart failure with New York Heart Association Class II-III (Heart Failure) HF symptomatology at screening and on guideline-directed HF therapy for at least 6 months prior to screening. * Have not changed optimal guideline-directed HF therapy, either ...

Countries:United StatesJapan
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