LY4213663 in healthy people and people with rheumatoid arthritis
Official title: A Phase 1, Multicenter, Randomized, Placebo-Controlled, Investigator- and Participant-Blinded, Single- and Multiple-Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of LY4213663 in Healthy Participants, and Two Open-Label, Multiple-Dose Evaluations of LY4213663 in Patients With Rheumatoid Arthritis.
Run by Eli Lilly and Company · NCT07258849 · Data updated 2026-11-12
This will test whether LY4213663 is safe and how the body handles it in healthy volunteers and people with rheumatoid arthritis.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 141 (estimated) |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 10 sites (Anniston, Alabama and 9 other locations) |
| Status | Recruiting |
| Started | December 2, 2025 |
| Main results expected | March 2028 |
| Study ends | March 2028 |
| Registry record updated | June 23, 2026 |
| Trial ID | NCT07258849 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with adult-onset rheumatoid arthritis for at least three months who meet the trial's weight and BMI requirements and who do not have Class 4 disease, ECG abnormalities, or active infections are the intended participants.
✕Probably not a fit
People with Class 4 RA, current acute infections, significant cardiac or other major organ disease, ECG abnormalities, or who fall outside the study's BMI/weight windows are unlikely to receive benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1, first-in-human/early clinical program that gives LY4213663 either under the skin (subcutaneous) or into a vein (intravenous) to healthy volunteers and to people with rheumatoid arthritis. The study includes single- and multiple-dose groups and contains placebo arms for comparison. Blood tests will measure how the drug is processed (pharmacokinetics) and any biological effects or safety signals (pharmacodynamics and adverse events). The active treatment and follow-up period lasts about 33 weeks excluding screening.
Why it matters
Potential benefit: If LY4213663 is well tolerated and shows appropriate blood-levels, it could advance toward later trials and potentially become a new option for people with rheumatoid arthritis.
How similar studies have gone: Although other biologic agents for RA have succeeded in later-phase trials, LY4213663 is an experimental early-phase agent and has not yet been shown effective.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Pinnacle Research Group, LLC
Anniston, Alabama, United States Recruiting -
Arizona Research Center
Phoenix, Arizona, United States Recruiting -
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida, United States Recruiting -
GNP Research at Mark Jaffe, MD
Cooper City, Florida, United States Recruiting -
Fortrea Clinical Research Unit
Daytona Beach, Florida, United States Recruiting -
AGA Clinical Trials
Hialeah, Florida, United States Recruiting
Show 4 more locations
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Advanced Pharma CR, LLC
Miami, Florida, United States Recruiting -
Floridian Clinical Research
Miami Lakes, Florida, United States Recruiting -
Oasis Clinical Research
Las Vegas, Nevada, United States Recruiting -
Universitätsklinikum Charité
Berlin, Germany Not yet recruiting
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.