Recruiting
Phase 1

LY4213663

Sponsor:

Eli Lilly and Company

Code:

NCT07258849

Conditions

Rheumatoid Arthritis (RA)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

LY4213663

LY4213663

Placebo

Placebo

Study Details

Brief summary:

The purpose of this study is to evaluate how well LY4213663 is tolerated and what side effects may occur in healthy participants and participants with rheumatoid arthritis (RA). The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm).

Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last approximately 33 weeks excluding screening.

Conditions

Rheumatoid Arthritis (RA)

Study ID

NCT07258849

Start date

Dec 2, 2025

Status verified date

Jun, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 months prior to screening

Exclusion Criteria:

Healthy Participants for SAD Part A and MAD Part B Only:

  • Have a history or presence of cardiovascular, respiratory, hepatic, ophthalmological, renal, gastrointestinal, endocrine, hematological, neurological, or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs

Participants with RA for Parts C and D Only:

  • Have Class 4 RA according to American College of Rheumatology (ACR) revised criteria
  • Have a 12-lead electrocardiogram (ECG) abnormality at screening
  • Have a current or recent acute active infection

Study Design

Enrollment

141 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: LY4213663 (Part A)

Single-ascending dose (SAD) of LY4213663 administered subcutaneously (SC) and intravenously (IV) in healthy participants

placebo comparator: Placebo (Part A)

SAD placebo administered SC and IV

experimental: LY4213663 (Part B)

Multiple-ascending doses (MAD) of LY4213663 administered SC and IV in healthy participants

placebo comparator: Placebo (Part B)

MAD placebo administered SC and IV

experimental: LY4213663 (Parts C and D)

Multiple doses of LY4213663 administered SC and IV in participants with RA

Interventions

LY4213663

Administered SC

LY4213663

Administered IV

Placebo

Administered SC

Placebo

Administered IV

Primary outcome measure

  • Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline up to Week 33 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Pinnacle Research Group, LLC

Recruiting

Anniston, Alabama, United States, 36207

Contacts

256-236-0055, ext 101

Principal Investigator:

Vishala Chindalore

Arizona Research Center

Recruiting

Phoenix, Arizona, United States, 85053

Contacts

602-773-3020

Principal Investigator:

Louise Taber

Clinical Research of West Florida, Inc. (Clearwater)

Recruiting

Clearwater, Florida, United States, 33765

Contacts

727-466-0078

Principal Investigator:

Robert Levin

GNP Research at Mark Jaffe, MD

Recruiting

Cooper City, Florida, United States, 33024

Contacts

754-248-3589

Principal Investigator:

Mark Jaffe

Fortrea Clinical Research Unit

Recruiting

Daytona Beach, Florida, United States, 32117

Contacts

866-429-3700

Principal Investigator:

Sharrell Cooper

AGA Clinical Trials

Recruiting

Hialeah, Florida, United States, 33012

Contacts

704-526-6864

Principal Investigator:

WILSON CUEVA

Advanced Pharma CR, LLC

Recruiting

Miami, Florida, United States, 33417

Contacts

305-220-2727, Ext 802

Principal Investigator:

Simon Abelson

Floridian Clinical Research

Recruiting

Miami Lakes, Florida, United States, 33016

Contacts

305-330-9977

Principal Investigator:

Christopher Mesa

Oasis Clinical Research

Recruiting

Las Vegas, Nevada, United States, 89121

Contacts

702-832-1369

Principal Investigator:

Stephen Tam

More Information

Sponsor

Eli Lilly and Company

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-21. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-06-23.