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LY4298445

Phase 1

Systemic Lupus Erythematosus | Small molecule | Immunology |Eli Lilly and Company|Trials Updated: Oct 8, 2026

LY4298445 development status

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

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

LY4298445 clinical trials

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 Sites10

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:AustraliaChinaJapan
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Recent Changes (Last 90 Days)

LOWOct 8, 2026NCT07276958lastUpdatePostDate: changed
LOWOct 8, 2026NCT07276958lastUpdatePostDate: changed
LOWSep 3, 2026NCT07276958Enrollment: 63 → 68
LOWSep 3, 2026NCT07276958Enrollment: 63 → 68

Frequently asked questions about LY4298445

What is LY4298445?

LY4298445 is an investigational small molecule being developed by Eli Lilly and Company for systemic lupus erythematosus, an autoimmune disease. It is in Phase 1 clinical development and has not been approved by the FDA. Lilly is also studying it in rheumatoid arthritis and healthy participants.

What is LY4298445 used for in systemic lupus erythematosus?

LY4298445 is being evaluated as a potential treatment for systemic lupus erythematosus, an autoimmune condition. It is investigational and has not been approved for any indication. The Phase 1 program also includes participants with rheumatoid arthritis and healthy volunteers, so its use in lupus remains under study.

Who makes LY4298445?

LY4298445 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 and in participants with systemic lupus erythematosus or rheumatoid arthritis.

What phase is LY4298445 in?

LY4298445 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The single Phase 1 trial is currently recruiting and is designed to enroll 68 participants, including healthy volunteers and people with systemic lupus erythematosus or rheumatoid arthritis.

What clinical trials is LY4298445 in?

LY4298445 is being studied in one Phase 1 trial, NCT07276958, titled A Study of LY4298445 in Healthy Participants and Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis. The trial is recruiting, is placebo controlled and randomized, and plans to enroll 68 participants across Australia, China, and Japan.

Is LY4298445 tested in healthy volunteers?

Yes. The Phase 1 trial NCT07276958 enrolls healthy volunteers alongside participants with systemic lupus erythematosus or rheumatoid arthritis. It is a randomized, placebo-controlled study of 68 participants, open to adults 18 years and older of any sex, and is recruiting in Australia, China, and Japan.