A Study of LY3473329 in Participants With Impaired and Normal Renal Function

Lilly

Status and phase: Active, not recruiting; Phase 1

Conditions: Renal Insufficiency

Treatments: Drug: LY3473329

Study type: Interventional

Funder types: Industry

Identifiers

NCT05778864

J2O-MC-EKBE (Other Identifier)

18638

Details and patient eligibility

About

The main purpose of this study is to assess the amount of study drug (LY3473329) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to participants with normal renal function. The safety and tolerability of LY3473329 will also be evaluated in these participants. The study will last up to 8 weeks including screening period.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²)
• Men who agree to use highly effective or effective methods of contraception, women of childbearing potential (WOCP) who agree to use highly effective or effective methods of contraception, and women not of childbearing potential (WNOCBP) may participate in this trial
• Have clinical laboratory test results within the normal reference range for the population

Exclusion criteria

• Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition that, in the opinion of the investigator, would potentially affect participant safety within the study
• Have any abnormality in the 12-lead electrocardiogram (ECG), blood pressure and/or pulse rate that, in the opinion of the investigator, increases the risks associated with participating in the study
• Hemoglobin less than 8 grams/deciliter (g/dL) and/or clinically significant anemia symptoms
• Have an average weekly alcohol intake that exceeds 21 units per week for males and 14 units per week for females or males older than 65 years of age
• Smoke more than 10 cigarettes per day or the equivalent
• Have donated blood of more than 500 milliliter (mL) within 3 months prior to screening

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 5 patient groups

LY3473329 (Control)

Experimental group

Description:

LY3473329 administered orally to participants with normal renal function

Treatment:

Drug: LY3473329

LY3473329 (Mild Renal Impairment)

Experimental group

Description:

LY3473329 administered orally to participants with mild renal impairment

Treatment:

Drug: LY3473329

LY3473329 (Moderate Renal Impairment)

Experimental group

Description:

LY3473329 administered orally to participants with moderate renal impairment

Treatment:

Drug: LY3473329

LY3473329 (Severe Renal Impairment)

Experimental group

Description:

LY3473329 administered orally to participants with severe renal impairment

Treatment:

Drug: LY3473329

LY3473329 (End-Stage Renal Disease)

Experimental group

Description:

LY3473329 administered orally to participants with end-stage renal disease

Treatment:

Drug: LY3473329