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LY3084077

Phase 1

Undisclosed | Small molecule | Other |Eli Lilly and Company|Trials Updated: Jul 30, 2018

LY3084077 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since May 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

LY3084077 clinical trials

LY3084077 · 1 trial · 1 indication

Phase 1 1
NCT01846702A Study of LY3084077 in Healthy ParticipantsHealthy Volunteers
COMPLETED43 Analytics
PHASE1COMPLETED
A Study of LY3084077 in Healthy Participants
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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
Pre-dose, Up to Day 190

An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

Secondary Endpoints

Pharmacokinetics (PK): Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) GLP1-Fc Domain of LY3084077
Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose
PK: Maximum Concentration (Cmax) GLP1-Fc Domain of LY3084077
Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose
Pharmacodynamics (PD): Percent Change From Baseline in Fasting Triglycerides
Baseline, Up to Day 15
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORSingle dose of placebo matching LY3084077 administered subcutaneously (SC).
LY3084077EXPERIMENTALSingle escalating doses (1 mg up to 300 mg) of LY3084077 administered SC.

Interventions

NameTypeDescription
PlaceboDRUGGiven as a SC injection.
LY3084077DRUGGiven as a SC injection.
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Eligibility Criteria

Age Range21 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Have normal blood pressure * Must be a healthy male or female who cannot become pregnant * Have a body mass index (BMI) of 18.5 to 40.0 kg/m\^2, inclusive, at screening Exclusion Criteria: * Have known allergies to fibroblast growth factor-21 (FGF21) analogues, glucagon-like...

Countries:Singapore
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Frequently asked questions about LY3084077

What is LY3084077?

LY3084077 is an investigational small molecule developed by Eli Lilly and Company. It has been studied in a Phase 1 clinical trial in healthy participants. The specific disease or condition it is intended to treat has not been disclosed, and it remains in early clinical development.

Who makes LY3084077?

LY3084077 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored the Phase 1 study of the compound in healthy participants.

What phase is LY3084077 in?

LY3084077 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The compound has not been approved by the FDA and remains investigational.

What clinical trials is LY3084077 in?

LY3084077 has been evaluated in one completed Phase 1 trial, NCT01846702, titled A Study of LY3084077 in Healthy Participants. The trial enrolled 43 healthy volunteers in Singapore, was randomized, double-blind, and placebo-controlled, and included participants aged 21 years and older.

Is LY3084077 approved by the FDA?

No. LY3084077 is an investigational small molecule in Phase 1 development and has not been approved by the FDA. Its only recorded clinical study, NCT01846702, has been completed.