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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

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment44

FDA Designations

No designations recorded

Clinical trial landscape

LY3461767 · 2 trials · 2 indications

Phase 1 2
NCT04840914A Study of LY3461767 in Participants With Chronic Heart Failure With Reduced Ejection FractionChronic Heart Failure With Reduced Ejection Fraction
COMPLETED44 Analytics
NCT04352114A Study of LY3461767 in Healthy ParticipantsHealthy
COMPLETED48 Analytics
PHASE1COMPLETED
A Study of LY3461767 in Participants With Chronic Heart Failure With Reduced Ejection Fraction
Chronic Heart Failure With Reduced Ejection FractionUnlock trial analytics
PHASE1COMPLETED
A Study of LY3461767 in Healthy Participants
HealthyUnlock trial analytics

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
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3461767
Baseline through Day 29
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY3461767EXPERIMENTALLY3461767 administered subcutaneously (SC).
PlaceboPLACEBO_COMPARATORPlacebo administered subcutaneously (SC).
LY3461767 - Subcutaneous (SC)EXPERIMENTALLY3461767 administered SC.
Placebo - SCPLACEBO_COMPARATORPlacebo administered SC.
LY3461767 - Intravenous (IV)EXPERIMENTALLY3461767 administered IV.

Interventions

NameTypeDescription
LY3461767DRUGAdministered SC.
PlaceboDRUGAdministered SC.
LY3461767 - SCDRUGAdministered SC.
LY3461767 - IVDRUGAdministered IV.
Placebo - SCDRUGAdministered SC.
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Eligibility Criteria

Age Range18 Years to 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 StatesJapanSingapore
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Frequently asked questions about LY3461767

What is LY3461767 used for?

LY3461767 is an investigational small molecule being studied for chronic heart failure with reduced ejection fraction. It was also evaluated in healthy participants to assess its safety and tolerability. The drug is in Phase 1 clinical development and is not approved for any use.

Who makes LY3461767?

LY3461767 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the stock exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the drug's safety and effects in healthy participants and in patients with chronic heart failure with reduced ejection fraction.

What phase is LY3461767 in?

LY3461767 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in healthy participants and one in participants with chronic heart failure with reduced ejection fraction. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is LY3461767 in?

LY3461767 has been studied in two completed Phase 1 trials. NCT04352114 evaluated the drug in 48 healthy participants in the United States and Singapore. NCT04840914 evaluated it in 44 participants with chronic heart failure with reduced ejection fraction in the United States and Japan.

Is LY3461767 the same as another drug?

LY3461767 is the only name provided for this investigational drug. No alternative names have been reported. It is a small molecule being developed by Eli Lilly and Company for chronic heart failure with reduced ejection fraction.