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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

Qualifiers

Have body weight of at least 50 kilograms (kg) and body mass index (BMI) between 18 and 32 kilogram per square meter (kg/m²), inclusive.

Are 18 to 75 years of age, inclusive.

Have body weight between 45 and 145 kg, inclusive, and BMI between 18 and 35 kg/m², inclusive.

Have a clinical diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria at least 6 months prior to screening.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • LY4298445
  • LY4298445

Treatment groups

63 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Locations

8
Australia
Nucleus Network4006, Brisbane Australia
Nucleus NetworkVIC 3004, Melbourne Australia
China
Peking University First Hospital100034, Beijing China
Peking University Third Hospital100191, Beijing China

Sponsors and collaborators

Eli Lilly and Company

Lead sponsor