A Study of LY3437943 in Healthy Participants and Participants With Impaired Renal Function

Study Overview
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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.

Official Title
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A Parallel-group, Phase 1, Open-label Study to Investigate the Pharmacokinetics of LY3437943 in Participants With Renal Impairment Compared With Healthy Participants

Conditions
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Healthy, Renal Insufficiency

Intervention / Treatment
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* Drug: LY3437943


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3437943 (Control)<br>LY3437943 administered subcutaneous (SC) to participants with normal renal function | Drug: LY3437943<br>* Administered SC.<br>|
| Experimental: LY3437943 (Severe Renal Impairment)<br>LY3437943 administered SC to participants with severe renal impairment | Drug: LY3437943<br>* Administered SC.<br>|
| Experimental: LY3437943 (End-Stage Renal Disease)<br>LY3437943 administered SC to participants with end-stage renal disease | Drug: LY3437943<br>* Administered SC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3437943 | PK: AUC0-∞ of LY3437943 | Predose up to 31 days postdose | 
| PK: Maximum observed concentration (Cmax) of LY3437943 | PK: Cmax of LY3437943 | Predose up to 31 days postdose |