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LY4213663

Phase 1

Rheumatoid Arthritis (RA) | Small molecule | Immunology |Eli Lilly and Company|Last Updated: Jun 23, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment141

FDA Designations

No designations recorded

Clinical trial landscape

LY4213663 · 1 trial · 1 indication

Phase 1 1
NCT07258849A Study of LY4213663 in Healthy Participants and Participants With Rheumatoid ArthritisRheumatoid Arthritis (RA)
RECRUITING141 Analytics
PHASE1RECRUITING
A Study of LY4213663 in Healthy Participants and Participants With Rheumatoid Arthritis
Rheumatoid Arthritis (RA)Unlock 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 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 to 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)

LOWJun 23, 2026NCT07258849lastUpdatePostDate: changed
LOWJun 23, 2026NCT07258849lastUpdatePostDate: changed

Frequently asked questions about LY4213663

What is LY4213663 used for?

LY4213663 is an investigational small molecule being developed for the treatment of Rheumatoid Arthritis (RA). It is currently in Phase 1 clinical development, meaning it has not yet been approved and is still being studied for safety and efficacy in clinical trials.

What does LY4213663 target?

LY4213663 is a small molecule, but its specific molecular target has not been disclosed. It is being studied in the immunology therapeutic area for Rheumatoid Arthritis, suggesting it may modulate immune pathways relevant to the disease, but the exact mechanism of action is not publicly available.

Who makes LY4213663?

LY4213663 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the stock exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the drug's safety and effectiveness in participants with Rheumatoid Arthritis.

What phase is LY4213663 in?

LY4213663 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to study the drug in healthy volunteers and individuals with Rheumatoid Arthritis.

What clinical trials is LY4213663 in?

LY4213663 is being studied in one active clinical trial with the identifier NCT07258849. This Phase 1 study is recruiting 141 participants in the United States and Germany, and it includes healthy volunteers as well as participants with Rheumatoid Arthritis. The trial is placebo-controlled and randomized.

Is LY4213663 the same as any other drug?

No alternative names for LY4213663 have been disclosed. It is identified solely by its code name LY4213663 in clinical trial registries and by its developer, Eli Lilly and Company. No other drug names or aliases are associated with this investigational compound.