A Study of LY4213663 in Healthy Participants and Participants With Rheumatoid Arthritis
Eli Lilly and Company · NCT07258849
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–75 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 1
- Target enrollment
- 141
- US sites recruiting
- 9
- Study start
- December 2, 2025
- Record last updated
- June 23, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: LY4213663; LY4213663; Placebo; Placebo
Conditions: Rheumatoid Arthritis (RA)
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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
Recruiting US locations
Pinnacle Research Group, LLC
Anniston, AL 36207
Site contact: 256-236-0055, ext 101
Arizona Research Center
Phoenix, AZ 85053
Site contact: 602-773-3020
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, FL 33765
Site contact: 727-466-0078
GNP Research at Mark Jaffe, MD
Cooper City, FL 33024
Site contact: 754-248-3589
Fortrea Clinical Research Unit
Daytona Beach, FL 32117
Site contact: 866-429-3700
AGA Clinical Trials
Hialeah, FL 33012
Site contact: 704-526-6864
Advanced Pharma CR, LLC
Miami, FL 33417
Site contact: 305-220-2727, Ext 802
Floridian Clinical Research
Miami Lakes, FL 33016
Site contact: 305-330-9977
Oasis Clinical Research
Las Vegas, NV 89121
Site contact: 702-832-1369
Study contacts (from the official record)
- Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · LillyTrials@Lilly.com
- Physicians interested in becoming principal investigators please contact · clinical_inquiry_hub@lilly.com
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