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LY3475766

Phase 1

Dyslipidemias | Small molecule | Cardiovascular |Eli Lilly and Company|Trials Updated: Apr 28, 2021

LY3475766 target and mechanism

ModalitySmall molecule

Also known as LY3475766 - IV

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

LY3475766 clinical trials

LY3475766 · 1 trial · 1 indication

Phase 1 1
NCT04052594A Study of LY3475766 in Healthy ParticipantsDyslipidemias
COMPLETED48 Analytics
PHASE1COMPLETED
A Study of LY3475766 in Healthy Participants
DyslipidemiasUnlock 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 up to Day 85

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 LY3475766
Predose up to Day 85
PK: Maximum Observed Drug Concentration (Cmax) of LY3475766
Predose up to Day 85
PK: Time to Maximum Observed Drug Concentration (Tmax) of LY3475766
Predose up to Day 85
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY3475766 - IVEXPERIMENTALLY3475766 administered intravenously (IV) to participants with dyslipidemia
Placebo - IVPLACEBO_COMPARATORPlacebo administered IV to participants with dyslipidemia
LY3475766 - SCEXPERIMENTALLY3475766 administered subcutaneously (SC) to participants with dyslipidemia
Placebo - SCPLACEBO_COMPARATORPlacebo administered SC to participants with dyslipidemia

Interventions

NameTypeDescription
LY3475766 - IVDRUGAdministered IV
LY3475766 - SCDRUGAdministered SC
Placebo - IVDRUGAdministered IV
Placebo - SCDRUGAdministered SC
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Are overtly healthy males or females, apart from dyslipidemia * Male participants must agree to adhere to contraception restrictions * Female participants must be of nonchildbearing potential and include those who are infertile due to surgical sterilization or those who are po...

Countries:United States
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Frequently asked questions about LY3475766

What is LY3475766?

LY3475766 is an investigational small molecule being developed by Eli Lilly and Company for dyslipidemias, a group of conditions involving abnormal levels of lipids such as cholesterol and triglycerides in the blood. It is in Phase 1 clinical development.

What is LY3475766 used for in dyslipidemias?

LY3475766 is being studied for dyslipidemias, which are disorders of lipid metabolism. It has been evaluated in a Phase 1 trial in healthy participants, and no approved use has been established. It remains an investigational therapy.

Who makes LY3475766?

LY3475766 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the clinical program evaluating the compound.

What phase is LY3475766 in?

LY3475766 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no later-stage trials are currently active. The compound has not been approved for any indication and remains investigational.

What clinical trials is LY3475766 in?

LY3475766 has been studied in one Phase 1 trial, NCT04052594, titled A Study of LY3475766 in Healthy Participants. The trial enrolled 48 healthy volunteers in the United States, was randomized, double-blind, and placebo-controlled, and has been completed.

Is LY3475766 the same as LY3475766 - IV?

Yes, LY3475766 - IV is an alternative name for LY3475766. Both refer to the same investigational small molecule developed by Eli Lilly and Company for dyslipidemias.