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LY3475766

Phase 1

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

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

Clinical trial landscape

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 used for?

LY3475766 is an investigational small molecule being developed for the treatment of dyslipidemias, a group of disorders characterized by abnormal levels of lipids in the blood. It is being studied in the cardiovascular therapeutic area. The drug is currently in Phase 1 clinical development and has not yet been approved by regulatory authorities.

How does LY3475766 work?

The specific molecular target of LY3475766 has not been disclosed in available information. As a small molecule intended for dyslipidemias, it is presumed to modulate lipid metabolism, but the exact mechanism of action remains under investigation in clinical trials.

Who is developing LY3475766?

LY3475766 is being developed by Eli Lilly and Company, a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug for the treatment of dyslipidemias.

What phase is LY3475766 in?

LY3475766 is in Phase 1 clinical development. It is an investigational drug that has not yet received regulatory approval. The Phase 1 trial has been completed, and the drug remains in early-stage clinical evaluation for the treatment of dyslipidemias.

What clinical trials is LY3475766 in?

LY3475766 has one completed Phase 1 clinical trial registered under the identifier NCT04052594. This study, titled 'A Study of LY3475766 in Healthy Participants,' was conducted in the United States and enrolled 48 participants. The trial was randomized, double-blind, and placebo-controlled, and it included healthy volunteers aged 18 years and older.

Is LY3475766 the same as any other drug?

No alternative names for LY3475766 have been disclosed. The drug is identified solely by its compound number LY3475766 in clinical trial registrations and available information. It is a distinct investigational agent being developed by Eli Lilly and Company for dyslipidemias.