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

NCT ID
NCT07258849
Registry status
Recruiting
Study type
Interventional
Phase
Phase 1
Sponsor
Eli Lilly and Company
Conditions
Rheumatoid Arthritis (RA)

Overview

ClinicalTrials.gov lists this study as Recruiting.

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.

Enrollment: 141 participants (Estimated).

What is being studied

  • Drug: LY4213663
  • Drug: Placebo

Who may be eligible

Ages
18 Years to 75 Years
Sex
All
Healthy volunteers accepted
Yes

ClinicalTrials.gov lists the following 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 locations

10 study locations are listed.

Recruiting site status is explicitly provided for 10 locations; 9 are listed as Recruiting.

Countries: Germany, United States

  • Alabama, United States: 1
  • Arizona, United States: 1
  • Florida, United States: 6
  • Nevada, United States: 1

Sample of listed locations

  • Pinnacle Research Group, LLC — Anniston, Alabama, 36207, United States — Recruiting
  • Arizona Research Center — Phoenix, Arizona, 85053, United States — Recruiting
  • Clinical Research of West Florida, Inc. (Clearwater) — Clearwater, Florida, 33765, United States — Recruiting
  • GNP Research at Mark Jaffe, MD — Cooper City, Florida, 33024, United States — Recruiting
  • Fortrea Clinical Research Unit — Daytona Beach, Florida, 32117, United States — Recruiting
  • AGA Clinical Trials — Hialeah, Florida, 33012, United States — Recruiting
  • Advanced Pharma CR, LLC — Miami, Florida, 33417, United States — Recruiting
  • Floridian Clinical Research — Miami Lakes, Florida, 33016, United States — Recruiting
  • Oasis Clinical Research — Las Vegas, Nevada, 89121, United States — Recruiting
  • Universitätsklinikum Charité — Berlin, 10117, Germany — Not yet recruiting

Study details

Start date
December 2, 2025
Primary completion date
March 1, 2028
Completion date
March 1, 2028
First posted
December 2, 2025

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07258849
Registry last updated
June 23, 2026
QualifiedStudies registry data refreshed
October 2, 2026
QualifiedStudies record fetched
October 2, 2026

View NCT07258849 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

About joining clinical research

Find clinical trials you may match with

QualifiedStudies can help you search for research opportunities related to your health. Availability of this specific study through QualifiedStudies has not been established.

Find clinical trials you may match with | Rheumatoid Arthritis studies | Clinical trial FAQ