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LY4298445

Phase 1

Healthy | Small molecule | Immunology |Eli Lilly and Company|Last Updated: Jun 4, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment63
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07276958A Study of LY4298445 in Healthy Participants and Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)PHASE1 RECRUITING 63Feb 4, 2026Mar 1, 2028Jun 4, 20261 Australia
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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 Chinese participants
LY4298445 Placebo (Part C)PLACEBO_COMPARATORSingle dose of LY4298445 administered SC in healthy Japanese and Chinese participants
Interventions
NameTypeDescription
LY4298445DRUGAdministered SC
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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:Australia
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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT07276958lastUpdatePostDate: changed
LOWJun 4, 2026NCT07276958lastUpdatePostDate: changed
LOWJun 4, 2026NCT07276958lastUpdatePostDate: changed
LOWJun 4, 2026NCT07276958lastUpdatePostDate: changed
LOWMay 26, 2026NCT07276958Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07276958studyFirstPostDate: changed