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LY4298445

Phase 1

Healthy | Small molecule | Immunology |Eli Lilly and Company|Last Updated: Sep 3, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment68

FDA Designations

No designations recorded

Clinical trial landscape

LY4298445 · 1 trial · 3 indications

Phase 1 1
NCT07276958A Study of LY4298445 in Healthy Participants and Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)Healthy
RECRUITING68 Analytics
PHASE1RECRUITING
A Study of LY4298445 in Healthy Participants and Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)
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 Week 52

A summary of 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 LY4298445
Baseline up to Approximately Week 57
PK: Maximum Concentration (Cmax) of LY4298445
Baseline up to Week 52
Pharmacodynamic (PD): Degree of Peripheral B Cell Depletion Following Biopsy in Participants
Baseline up to Week 52
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY4298445 (Part A1)EXPERIMENTALSingle-ascending dose (SAD) of LY4298445 administered subcutaneously (SC) or intravenously (IV) in healthy participants
LY4298445 Placebo (Part A1)PLACEBO_COMPARATORSAD of LY4298445 administered SC or IV in healthy participants
LY4298445 (Part A2)EXPERIMENTALSAD of LY4298445 administered SC in participants with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA)
LY4298445 (Part B)EXPERIMENTALMultiple-ascending doses (MAD) of LY4298445 administered SC in participants with SLE or RA
LY4298445 (Part C)EXPERIMENTALSingle dose of LY4298445 administered SC in healthy Japanese and, optionally, Chinese participants
LY4298445 Placebo (Part C)PLACEBO_COMPARATORSingle dose of LY4298445 administered SC in healthy Japanese and, optionally, Chinese participants

Interventions

NameTypeDescription
LY4298445DRUGAdministered SC
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites9

Inclusion Criteria: Healthy Participants Healthy participants between the ages of 18 and 55 years. * Have body weight of at least 50 kilograms (kg) and body mass index (BMI) between 18 and 32 kilogram per square meter (kg/m²), inclusive. Participants with Systemic Lupus Erythematosus (SLE) * Are...

Countries:AustraliaChina
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Recent Changes (Last 90 Days)

LOWSep 3, 2026NCT07276958Enrollment: 63 → 68
LOWSep 3, 2026NCT07276958Enrollment: 63 → 68
LOWJul 17, 2026NCT07276958lastUpdatePostDate: changed
LOWJul 17, 2026NCT07276958lastUpdatePostDate: changed
LOWJun 23, 2026NCT07276958lastUpdatePostDate: changed
LOWJun 23, 2026NCT07276958lastUpdatePostDate: changed

Frequently asked questions about LY4298445

What is LY4298445 used for?

LY4298445 is an investigational small molecule being studied for use in healthy participants and in participants with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). It is being developed by Eli Lilly and Company and is currently in Phase 1 clinical development.

What does LY4298445 target?

LY4298445 is a small molecule in the immunology therapeutic area. Its specific molecular target has not been disclosed in the available information, so its mechanism of action is not described here.

Who makes LY4298445?

LY4298445 is being developed by Eli Lilly and Company, a biopharmaceutical company traded on the stock exchange under the ticker LLY. The drug is currently in Phase 1 clinical trials.

What phase is LY4298445 in?

LY4298445 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study is currently recruiting participants to evaluate the drug.

What clinical trials is LY4298445 in?

LY4298445 is being studied in a Phase 1 clinical trial with the identifier NCT07276958. This trial is recruiting participants and is designed to evaluate the drug in healthy participants and in those with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). The study is being conducted in Australia and China.

Is LY4298445 the same as any other drug?

LY4298445 is the only name provided for this investigational drug. No alternative names have been mentioned in the available information, so it is not known to be the same as any other drug.