A Study of LY3502970 in Participants With Normal and 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 (LY3502970) 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 LY3502970 will also be evaluated in these participants. The study will last up to 6 weeks including screening period.

Official Title
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A Phase 1, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Renal Function and Participants With Renal Impairment

Conditions
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Healthy, Renal Insufficiency

Intervention / Treatment
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* Drug: LY3502970


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a body mass index within the range 18.5 to 42.0 kilograms per meter squared (kg/m²), inclusive. Men and women who agree to use highly effective or effective methods of contraception may participate in this trial. Participants with Normal Renal Function: Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal renal function. Have estimated glomerular filtration rate (eGFR) of greater than or equal to 90 milliliter per minute (mL/min) Participants with Renal Impairment: Severe renal impairment: Have eGFR of 15 to 29 mL/min and not requiring hemodialysis. ESRD: Participants who have been on a stable hemodialysis schedule for at least 3 months prior to planned dosing. Exclusion Criteria: Have a current, functioning organ transplant. Non-functional renal allografts may be allowed. Regularly use known drugs of abuse or show positive findings on urinary drug screen that are not otherwise explained by permitted concomitant medications. Have known allergies to LY3502970, related compounds, or any components of the formulation, or history of severe atopy. Are lactating, pregnant, or intend to become pregnant, or to breastfeed during the study. Have a history or presence of chronic or acute pancreatitis Participants with Renal Impairment: Have hemoglobin <8.5 g/dL. Participants with Type 2 Diabetes Mellitus if they have taken any Glucagon-like Peptide-1 Receptor Agonists (GLP1-RA) or a Dipeptidyl Peptidase 4 (DPP4) inhibitor in the past 6 weeks or 5 half-lives prior to dosing, whichever is longer, prior to dosing on Day 1

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: LY3502970 (Control)<br>LY3502970 administered orally to participants with normal renal function | Drug: LY3502970<br>* Administered orally.<br>|
| Experimental: LY3502970 (Severe Renal Impairment)<br>LY3502970 administered orally to participants with severe renal impairment | Drug: LY3502970<br>* Administered orally.<br>|
| Experimental: LY3502970 (End-Stage Renal Disease)<br>LY3502970 administered orally to participants with end-stage renal disease (ESRD) | Drug: LY3502970<br>* Administered orally.<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 LY3502970 | PK: (AUC0-∞) of LY3502970 | Predose up to 12 days postdose | 
| PK: Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3502970 | PK: AUC0-tlast of LY3502970 | Predose up to 12 days postdose | 
| PK: Maximum observed concentration (Cmax) of LY3502970 | PK: Cmax of LY3502970 | Predose up to 12 days postdose |