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LY4088044

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Aug 7, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment104

FDA Designations

No designations recorded

Clinical trial landscape

LY4088044 · 1 trial · 1 indication

Phase 1 1
NCT07090785A Study of LY4088044 in Healthy ParticipantsHealthy
RECRUITING104 Analytics
PHASE1RECRUITING
A Study of LY4088044 in Healthy Participants
HealthyUnlock 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 up to Approximately Day 190

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

Secondary Endpoints

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4088044
Baseline up to Approximately Day 190
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4088044
Baseline up to Approximately Day 190
Pharmacodynamics (PD): Protein Levels in Skin Samples
Baseline up to Approximately Day 190
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY4088044 (Part A)EXPERIMENTALSingle-ascending dose (SAD) of LY4088044 administered intravenously (IV)
Placebo (Part A)PLACEBO_COMPARATORAdministered IV
LY4088044 (Part B)EXPERIMENTALSAD of LY4088044 administered subcutaneously (SC)
Placebo (Part B)PLACEBO_COMPARATORAdministered SC
LY4088044 (Part C)EXPERIMENTALMultiple-ascending doses (MAD) of LY4088044 administered IV
Placebo (Part C)PLACEBO_COMPARATORAdministered IV

Interventions

NameTypeDescription
LY4088044DRUGAdministered IV
PlaceboDRUGAdministered IV
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites6

Inclusion Criteria: * Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and cardiac monitoring * Have a body mass index (BMI) within the range 18.5 to 30 kilogram per square meter (kg/m²) Exclusion Criteria: * A...

Countries:United StatesNew ZealandSingapore
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Recent Changes (Last 90 Days)

LOWAug 7, 2026NCT07090785lastUpdatePostDate: changed
LOWAug 7, 2026NCT07090785lastUpdatePostDate: changed
LOWJun 23, 2026NCT07090785lastUpdatePostDate: changed
LOWJun 23, 2026NCT07090785lastUpdatePostDate: changed

Frequently asked questions about LY4088044

What is LY4088044?

LY4088044 is an investigational small molecule being developed by Eli Lilly and Company. It is currently in Phase 1 clinical development for use in healthy participants. The drug is being studied in a placebo-controlled, double-blind, randomized trial to evaluate its safety and tolerability.

What is LY4088044 used for?

LY4088044 is being studied for use in healthy participants. The ongoing Phase 1 trial is designed to assess the drug's safety and tolerability in this population. It is not yet approved for any medical condition and remains in early-stage clinical development.

Who makes LY4088044?

LY4088044 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting a Phase 1 clinical trial of this investigational small molecule in healthy participants.

What phase is LY4088044 in?

LY4088044 is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. It is currently being evaluated in a Phase 1 trial involving healthy participants to assess its safety and tolerability.

What clinical trials is LY4088044 in?

LY4088044 is being studied in a Phase 1 clinical trial with the identifier NCT07090785, titled "A Study of LY4088044 in Healthy Participants." The trial is recruiting 104 participants in the United States, New Zealand, and Singapore. It is a randomized, double-blind, placebo-controlled study.

Is LY4088044 FDA approved?

LY4088044 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The ongoing trial is evaluating the drug in healthy participants, and it has not yet completed the clinical development process required for regulatory approval.