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LY4088044

Phase 1

Undisclosed | Small molecule | Other |Eli Lilly and Company|Trials Updated: Oct 7, 2026

LY4088044 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2025

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

LY4088044 clinical trials

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)

LOWOct 7, 2026NCT07090785lastUpdatePostDate: changed
LOWOct 7, 2026NCT07090785lastUpdatePostDate: changed
LOWAug 7, 2026NCT07090785lastUpdatePostDate: changed
LOWAug 7, 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, with a single trial enrolling healthy adult volunteers. No therapeutic indication has been disclosed for the compound.

Who is developing LY4088044?

LY4088044 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the Phase 1 study evaluating the compound in healthy participants.

What phase is LY4088044 in?

LY4088044 is in Phase 1 clinical development. It has not been approved by the FDA and remains investigational. One Phase 1 trial is currently recruiting, and no trials have been completed.

What clinical trials is LY4088044 in?

LY4088044 is being studied in one Phase 1 trial, NCT07090785, titled A Study of LY4088044 in Healthy Participants. The trial is recruiting 104 healthy volunteers across the United States, New Zealand, and Singapore, and it is randomized, double-blind, and placebo-controlled.

What is the design of the LY4088044 Phase 1 trial?

The Phase 1 trial of LY4088044, NCT07090785, is a randomized, double-blind, placebo-controlled study in healthy participants. It plans to enroll 104 adults aged 18 years and older of all sexes. Participants are being recruited in the United States, New Zealand, and Singapore.