A Study of LY4298445 in Healthy Participants and Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Healthy, Systemic Lupus Erythematosus, Rheumatoid Arthritis

In brief

The purpose of this study is to investigate the safety and tolerability of LY4298445 in healthy participants and in participants with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). Participation in the study will last up to approximately 52 weeks.

Key facts

Study ID

NCT07276958

Run by

Eli Lilly and Company

People needed

63

Starts

2026-02-04

Expected to finish

2028-03-01

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Have known allergies to LY4298445, related compounds, or any components of the formulation
• Are individuals assigned female at birth (AFAB) who are lactating or have a positive pregnancy test at screening or Day -1.
• Have severe active lupus-associated renal disease (lupus nephritis) defined clinically and/or by
• urine protein/creatinine ratio greater than 200 milligrams per millimole (mg/mmol) (as an estimate of approximate proteinuria greater than 2 reams (g) per day) or
• an estimated glomerular filtration rate (eGFR) less than 40 milliliters per minute (mL/min)/1.73 m² at screening, as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) 2021.
• requiring hemodialysis within 6 months prior to screening
• Have active central nervous system lupus as defined by ACR nomenclature for neuropsychiatric lupus syndromes and as captured by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K); seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, and cerebrovascular accident, within 2 months prior to screening
• Have a Class 4 RA according to the ACR revised criteria

Where it is running

• Nucleus Network — Brisbane, Australia (enrolling)
• Nucleus Network — Melbourne, Australia (enrolling)
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, China
• Peking University First Hospital — Beijing, China
• Peking University Third Hospital — Beijing, China
• Xiangya Hospital of Central South University — Changsha, China
• Renji Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, China
• Anhui Provincial Hospital — Hefei, China
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, China

Full record on ClinicalTrials.gov

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