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LY4213663

Phase 1

Rheumatoid Arthritis (RA) | Small molecule | Immunology |Eli Lilly and Company|Last Updated: May 22, 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 Enrollment141
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07258849A Study of LY4213663 in Healthy Participants and Participants With Rheumatoid ArthritisPHASE1 RECRUITING 141Dec 2, 2025Mar 1, 2028May 22, 202610 United States, Germany
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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 33

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

Secondary Endpoints
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4213663
Baseline up to Week 33
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4213663
Baseline up to Week 33
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY4213663 (Part A)EXPERIMENTALSingle-ascending dose (SAD) of LY4213663 administered subcutaneously (SC) and intravenously (IV) in healthy participants
Placebo (Part A)PLACEBO_COMPARATORSAD placebo administered SC and IV
LY4213663 (Part B)EXPERIMENTALMultiple-ascending doses (MAD) of LY4213663 administered SC and IV in healthy participants
Placebo (Part B)PLACEBO_COMPARATORMAD placebo administered SC and IV
LY4213663 (Parts C and D)EXPERIMENTALMultiple doses of LY4213663 administered SC and IV in participants with RA
Interventions
NameTypeDescription
LY4213663DRUGAdministered SC
PlaceboDRUGAdministered SC
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites10

Inclusion Criteria: * Have a body mass index (BMI) of 18.0 to 32.0 kilogram per square meter (kg/m²), inclusive Part C and D Only: * Have a body weight at least 50 kilograms and BMI within the range 18.0 to 40.0 kg/m² (inclusive) at screening * Have a diagnosis of adult-onset RA for at least 3 mo...

Countries:United StatesGermany
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07258849Enrollment: 134 → 141
LOWMay 24, 2026NCT07258849studyFirstPostDate: changed