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LY3053102

Phase 1

Healthy Volunteers | Small molecule | Other |Eli Lilly and Company|Last Updated: Jul 19, 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 Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01736241A Study of LY3053102 in Healthy ParticipantsPHASE1 COMPLETED 41Dec 1, 2012Jul 1, 2013Jul 19, 20181 Singapore
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Study Endpoints
Primary Endpoints
Number of Participants With One or More Adverse Events (AEs) or Any Serious AEs
Baseline through Day 31

A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Secondary Endpoints
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3053102
Time 0 to 168 hours after study drug administration on Day 1
PK: Observed Maximum Drug Concentration (Cmax) of LY3053102
Time 0 to 168 hours after study drug administration on Day 1
Number of Participants Who Developed Anti-LY3053102 Antibodies
Baseline, up to Day 31
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY3053102EXPERIMENTALA single 2-, 7-, 20-, 50-, 150-, or 405-milligrams (mg) dose of LY3053102 was subcutaneously administered to newly randomized participants in 6 escalating dose level cohorts. The dose was escalated based on the safety results over at least a 7-day evaluation period postdose. The dose escalation occurred over 13 weeks proceeding according to tolerability at each dose level.
PlaceboPLACEBO_COMPARATORA single dose of LY3053102-matching placebo was administered subcutaneously to 1 newly randomized participant in each LY3053102-dose level cohort over 13 weeks.
Interventions
NameTypeDescription
LY3053102DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range21 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Normal blood pressure * Female participants were not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause * Had a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m\^2), inclusive, ...

Countries:Singapore
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