A Study of LY4213663 in Healthy Participants and Participants With Rheumatoid Arthritis

Last updated: June 19, 2026
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

1

Condition

Rheumatoid Arthritis

Treatment

Placebo

LY4213663

Clinical Study ID

NCT07258849
27749
2025-523980-39-00
J6T-MC-KYAA
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 141
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
December 02, 2025
Estimated Completion Date:
March 31, 2028

Connect with a study center

  • Universitätsklinikum Charité

    Berlin, 10117
    Germany

    Site Not Available

  • Pinnacle Research Group, LLC

    Anniston, Alabama 36207
    United States

    Active - Recruiting

  • Arizona Research Center

    Phoenix, Arizona 85053
    United States

    Active - Recruiting

  • Clinical Research of West Florida, Inc. (Clearwater)

    Clearwater, Florida 33765
    United States

    Active - Recruiting

  • GNP Research at Mark Jaffe, MD

    Cooper City, Florida 33024
    United States

    Active - Recruiting

  • Fortrea Clinical Research Unit

    Daytona Beach, Florida 32117
    United States

    Active - Recruiting

  • AGA Clinical Trials

    Hialeah, Florida 33012
    United States

    Active - Recruiting

  • Advanced Pharma CR, LLC

    Miami, Florida 33417
    United States

    Active - Recruiting

  • Floridian Clinical Research

    Miami Lakes, Florida 33016
    United States

    Active - Recruiting

  • Oasis Clinical Research

    Las Vegas, Nevada 89121
    United States

    Active - Recruiting

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