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

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-17

Study Completion Date

2024-09-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Renal Insufficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LY3473329 (Control)

LY3473329 administered orally to participants with normal renal function

Group Type EXPERIMENTAL

LY3473329

Intervention Type DRUG

Administered orally.

LY3473329 (Mild Renal Impairment)

LY3473329 administered orally to participants with mild renal impairment

Group Type EXPERIMENTAL

LY3473329

Intervention Type DRUG

Administered orally.

LY3473329 (Moderate Renal Impairment)

LY3473329 administered orally to participants with moderate renal impairment

Group Type EXPERIMENTAL

LY3473329

Intervention Type DRUG

Administered orally.

LY3473329 (Severe Renal Impairment)

LY3473329 administered orally to participants with severe renal impairment

Group Type EXPERIMENTAL

LY3473329

Intervention Type DRUG

Administered orally.

LY3473329 (End-Stage Renal Disease)

LY3473329 administered orally to participants with end-stage renal disease

Group Type EXPERIMENTAL

LY3473329

Intervention Type DRUG

Administered orally.

Interventions

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LY3473329

Administered orally.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes