A Study of LY3437943 in Healthy Participants and Participants With Impaired 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

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-16

Study Completion Date

2023-09-05

Brief Summary

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The main purpose of this study is to assess the amount of study drug 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 healthy participants. The study will last up to 5 weeks, excluding screening.

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Detailed Description

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Conditions

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Healthy 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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LY3437943 (Control)

LY3437943 administered subcutaneous (SC) to participants with normal renal function

Group Type EXPERIMENTAL

LY3437943

Intervention Type DRUG

Administered SC.

LY3437943 (Severe Renal Impairment)

LY3437943 administered SC to participants with severe renal impairment

Group Type EXPERIMENTAL

LY3437943

Intervention Type DRUG

Administered SC.

LY3437943 (End-Stage Renal Disease)

LY3437943 administered SC to participants with end-stage renal disease

Group Type EXPERIMENTAL

LY3437943

Intervention Type DRUG

Administered SC.

Interventions

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LY3437943

Administered SC.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Normal Participants:

* Healthy male and female participants as determined by physical examination
* Participants with normal renal function assessed by estimated glomerular filtration rate (eGFR) ≥ 90 milliliter per minute (mL/min).
* Body mass index (BMI) ≥ 19.0 and ≤ 40.0 kilograms per meter squared (kg/m²)
* Male participants who agree to use contraception and female participants of child bearing potential must agree to use contraceptive methods and women not of child bearing potential can participate.

Participants with Renal Impairment:

* Have acceptable blood pressure (BP) and pulse rate, as determined by the investigator
* Participants with type 2 diabetes must have a glycated hemoglobin (HbA1c) ≥ 5.0% and ≤ 11.5%
* Are males or females with severe renal impairment as determined by a stable eGFR \<30 mL/min, not requiring hemodialysis OR
* Are males or females with end-stage renal disease (have received hemodialysis for at least 3 months)

Exclusion Criteria

* Have known allergies to LY3437943 or related compounds
* Have a current, functioning organ transplant. Nonfunctional renal allografts may be allowed
* Have any abnormality in the 12-lead electrocardiogram (ECG)
* Are women with a positive pregnancy test or women who are lactating

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes