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LY3090106

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: May 3, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

LY3090106 · 2 trials · 2 indications

Phase 1 2
NCT03736772A Study of LY3090106 in Japanese and Caucasian Healthy ParticipantsHealthy
COMPLETED30 Analytics
NCT02614716A Study of LY3090106 in Participants With Sjögren's Syndrome (SS)Sjögren's Syndrome
COMPLETED32 Analytics
PHASE1COMPLETED
A Study of LY3090106 in Japanese and Caucasian Healthy Participants
HealthyUnlock trial analytics
PHASE1COMPLETED
A Study of LY3090106 in Participants With Sjögren's Syndrome (SS)
Sjögren's SyndromeUnlock 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 through 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

Number of Participants with One or More Adverse Event(s) Considered by the Investigator to be Related to Study Drug Administration
Baseline through Study Completion (Day 197)

Secondary Endpoints

Maximum Observed Drug Concentration (Cmax) of LY3090106
Baseline through Day 85
Area Under the Concentration-Versus-Time Curve (AUC) of LY3090106
Baseline through Day 85
Pharmacokinetics: Maximum Concentration (Cmax) of LY3090106
Baseline through Day 197
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY3090106EXPERIMENTALLY3090106 administered subcutaneously (SC)
PlaceboPLACEBO_COMPARATORPlacebo administered SC

Interventions

NameTypeDescription
LY3090106DRUGAdministered SC
PlaceboDRUGAdministered SC
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Eligibility Criteria

Age Range20 Years to 64 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Overtly healthy Japanese or Caucasian * Body mass index (BMI) 18.0 - 32.0 kilograms per square meter (kg/m²) Exclusion Criteria: * Have participated, within the last 30 days, in a clinical study involving an investigational product (IP). If the previous IP has a long half-li...

Countries:United StatesBulgariaGeorgiaRomania
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Frequently asked questions about LY3090106

What is LY3090106 used for?

LY3090106 is an investigational small molecule being studied for the treatment of Sjögren's syndrome. It has also been evaluated in healthy participants to assess its safety and tolerability. The drug is in Phase 1 clinical development and is not yet approved for any use.

Who makes LY3090106?

LY3090106 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 trials to evaluate the drug's safety and efficacy in Sjögren's syndrome and in healthy volunteers.

What phase is LY3090106 in?

LY3090106 is in Phase 1 clinical development. Two Phase 1 trials have been completed: one in participants with Sjögren's syndrome and another in healthy Japanese and Caucasian participants. The drug remains investigational and has not received regulatory approval.

What clinical trials has LY3090106 been in?

LY3090106 has been studied in two completed Phase 1 trials. NCT02614716 enrolled 32 participants with Sjögren's syndrome in the United States, Bulgaria, Georgia, and Romania. NCT03736772 enrolled 30 healthy Japanese and Caucasian participants in the United States. Both trials were randomized, double-blind, and placebo-controlled.

Is LY3090106 the same as any other drug?

LY3090106 is the drug name used in clinical trials. No alternative names have been reported for this investigational compound. It is being studied under this identifier by Eli Lilly and Company in its Phase 1 clinical program.