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LY3084077

Phase 1

Healthy Volunteers | Small molecule | Other |Eli Lilly and Company|Last Updated: Jul 30, 2018

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 Enrollment43
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01846702A Study of LY3084077 in Healthy ParticipantsPHASE1 COMPLETED 43May 1, 2013Dec 1, 2013Jul 30, 20181 Singapore
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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 — 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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