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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-02

Study Completion Date

2028-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Rheumatoid Arthritis (RA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LY4213663 (Part A)

Single-ascending dose (SAD) of LY4213663 administered subcutaneously (SC) and intravenously (IV) in healthy participants

Group Type EXPERIMENTAL

LY4213663

Intervention Type DRUG

Administered SC

LY4213663

Intervention Type DRUG

Administered IV

Placebo (Part A)

SAD placebo administered SC and IV

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Placebo

Intervention Type DRUG

Administered IV

LY4213663 (Part B)

Multiple-ascending doses (MAD) of LY4213663 administered SC and IV in healthy participants

Group Type EXPERIMENTAL

LY4213663

Intervention Type DRUG

Administered SC

LY4213663

Intervention Type DRUG

Administered IV

Placebo (Part B)

MAD placebo administered SC and IV

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Placebo

Intervention Type DRUG

Administered IV

LY4213663 (Parts C and D)

Multiple doses of LY4213663 administered SC and IV in participants with RA

Group Type EXPERIMENTAL

LY4213663

Intervention Type DRUG

Administered SC

LY4213663

Intervention Type DRUG

Administered IV

Interventions

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LY4213663

Administered SC

Intervention Type DRUG

LY4213663

Administered IV

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Placebo

Administered IV

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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