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LY3053102

Phase 1

Healthy Volunteers | Small molecule | Other |Eli Lilly and Company|Last Updated: Jul 19, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment41

FDA Designations

No designations recorded

Clinical trial landscape

LY3053102 · 1 trial · 1 indication

Phase 1 1
NCT01736241A Study of LY3053102 in Healthy ParticipantsHealthy Volunteers
COMPLETED41 Analytics
PHASE1COMPLETED
A Study of LY3053102 in Healthy Participants
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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 to 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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Frequently asked questions about LY3053102

What is LY3053102 used for?

LY3053102 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in early clinical development. The only completed trial evaluated its effects in healthy participants to assess safety and tolerability.

What does LY3053102 target?

The molecular target of LY3053102 has not been disclosed. The drug is a small molecule, but its specific biological target is not publicly available from the clinical trial information provided.

Who makes LY3053102?

LY3053102 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker LLY. The company sponsored the clinical trial of this investigational drug.

What phase is LY3053102 in?

LY3053102 is in Phase 1 clinical development. The single trial listed for this drug is a Phase 1 study that has been completed. The drug remains investigational and has not received regulatory approval.

What clinical trials is LY3053102 in?

LY3053102 has one completed Phase 1 trial, NCT01736241, titled 'A Study of LY3053102 in Healthy Participants.' This randomized, double-blind, placebo-controlled study enrolled 41 healthy volunteers in Singapore and has been completed.

Is LY3053102 the same as any other drug?

No alternative names for LY3053102 have been disclosed. The drug is identified only by its code name LY3053102 in the clinical trial information.