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LY3981314

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: May 19, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment76

FDA Designations

No designations recorded

Clinical trial landscape

LY3981314 · 1 trial · 1 indication

Phase 1 1
NCT07005284A Study of LY3981314 in Healthy ParticipantsHealthy
ACTIVE NOT_RECRUITING76 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study of LY3981314 in Healthy Participants
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Study Endpoints

Primary Endpoints

Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline up to Approximately Week 25

A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module

Secondary Endpoints

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3981314
Baseline Up to Approximately Week 25
PK: Maximum Concentration (Cmax) of LY3981314
Baseline up to Approximately Week 25
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY3981314 Part AEXPERIMENTALSingle-ascending doses of LY3981314 administered subcutaneously (SC)
LY3981314 Part BEXPERIMENTALSingle dose of LY3981314 administered SC
Placebo Part APLACEBO_COMPARATORPlacebo administered SC
Placebo Part BPLACEBO_COMPARATORPlacebo administered SC

Interventions

NameTypeDescription
LY3981314DRUGAdministered SC
PlaceboDRUGAdministered SC
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead electrocardiogram (ECG) * Individuals assigned male at birth who agree to follow contraceptive requirements, or individuals assig...

Countries:United States
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Frequently asked questions about LY3981314

What is LY3981314 used for?

LY3981314 is an investigational small molecule being studied in healthy participants. It is currently in Phase 1 clinical development, with an active trial evaluating its safety and tolerability in healthy volunteers. The drug is not approved for any condition and remains in early-stage clinical testing.

Who makes LY3981314?

LY3981314 is being developed by Eli Lilly and Company, a biopharmaceutical company traded on the NYSE under the ticker LLY. The company is conducting a Phase 1 clinical trial of LY3981314 in healthy participants in the United States.

What phase is LY3981314 in?

LY3981314 is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. It is being studied in a single active Phase 1 trial involving healthy volunteers, with no completed trials to date.

What clinical trials is LY3981314 in?

LY3981314 is being evaluated in one active clinical trial, NCT07005284, titled "A Study of LY3981314 in Healthy Participants." This Phase 1, randomized, double-blind, placebo-controlled study is enrolling 76 healthy adults aged 18 years and older in the United States.

Is LY3981314 FDA approved?

LY3981314 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The ongoing trial, NCT07005284, is designed to assess the drug in healthy participants, and the drug has not yet been studied in patients with any disease condition.