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A Study of LY4213663 in Healthy Participants and Participants With Rheumatoid Arthritis
NCT07258849 · Eli Lilly and Company
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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.
About this study
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 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 target: 134 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-12-02
Estimated completion: 2028-03
Last updated: 2026-04-17
Interventions
Drug: LY4213663Drug: LY4213663Drug: PlaceboDrug: Placebo
Primary outcomes
- • 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)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · study_director, Eli Lilly and Company
All locations (9)
Pinnacle Research Group, LLCRecruiting
Anniston, Alabama, United States
Arizona Research CenterRecruiting
Phoenix, Arizona, United States
Clinical Research of West Florida, Inc. (Clearwater)Not Yet Recruiting
Clearwater, Florida, United States
GNP Research at Mark Jaffe, MDRecruiting
Cooper City, Florida, United States
Fortrea Clinical Research UnitRecruiting
Daytona Beach, Florida, United States
AGA Clinical TrialsRecruiting
Hialeah, Florida, United States
Advanced Pharma CR, LLCRecruiting
Miami, Florida, United States
Floridian Clinical ResearchRecruiting
Miami Lakes, Florida, United States
Oasis Clinical ResearchRecruiting
Las Vegas, Nevada, United States