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LY3461767

Phase 1

Chronic Heart Failure With Reduced Ejection Fraction | Small molecule | Cardiovascular |Eli Lilly and Company|Last Updated: May 30, 2024

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment44
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04840914A Study of LY3461767 in Participants With Chronic Heart Failure With Reduced Ejection FractionPHASE1 COMPLETED 44 — — Jun 1, 2021May 9, 2024May 30, 20247 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 Day 90

A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Endpoints
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3461767
Predose up to 48 hours post end of infusion
PK: Maximum Concentration (Cmax) of LY3461767
Predose up to 48 hours post end of infusion
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY3461767EXPERIMENTALLY3461767 administered subcutaneously (SC).
PlaceboPLACEBO_COMPARATORPlacebo administered subcutaneously (SC).
Interventions
NameTypeDescription
LY3461767DRUGAdministered SC.
PlaceboDRUGAdministered SC.
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Are males and in agreement to follow contraceptive requirements, or women of non-child-bearing potential * Have a body mass index (BMI) of \</= 45.0 kilograms per square meter (kg/m²) * Have chronic stable heart failure (New York Heart Association (NYHA) classification II and ...

Countries:United StatesJapan
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