A Study of LY3502970 in Participants With Impaired and Normal Liver Function

Study Overview
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Brief Summary
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The main purpose of this study is to measure how much of LY3502970 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function compared to participants with normal liver function. The safety and tolerability of LY3502970 will also be evaluated. The study may last up to 6 weeks for each participant including the screening period.

Official Title
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A Phase 1, Multicenter, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Hepatic Function and Participants With Mild, Moderate, or Severe Hepatic Impairment

Conditions
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Healthy, Hepatic Insufficiency

Intervention / Treatment
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* Drug: LY3502970


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women with body weight of at least 45 kilograms and a body mass index of 18.5 to 40.0 kilograms per meter squared (kg/m²). Both healthy individuals and individuals with hepatic impairment classified as Child-Pugh Score A, B, C that is mild, moderate, or severe impairment, respectively, liver disease can participate who are considered acceptable for participation in this study by the investigator. Participants must have a diagnosis of chronic hepatic impairment for more than 6 months per physician diagnosis and standard of care practice, with no clinically significant changes within 30 days prior to study intervention administration. Participants may have mild stable baseline medical conditions for which neither the condition nor treatments received would negatively impact the health of the participant or study conduct. Have acceptable BP and pulse rate, as determined by the investigator at screening. No significant history of spontaneous or ethanol induced hypoglycemia. Have T2DM controlled with diet or exercise alone or on stable doses of anti-diabetic medications such as metformin or sulfonylureas, for at least 8 weeks prior to screening. Participants with Mild to Severe Hepatic Impairment who have a hemoglobin level of at least 8.5 grams/deciliter. Participants with both T2DM and Hepatic Impairment have T2DM controlled with diet or exercise alone or on stable doses of anti-diabetic medications such as metformin or sulfonylureas, for at least 8 weeks prior to screening. Participants with both T2DM and Hepatic Impairment have a hemoglobin A1c greater than or equal to 5.0% and less than or equal to 11.0% at the screening visit. Participants with both T2DM and Hepatic Impairment have clinical laboratory test results within normal range or deemed clinically insignificant by the investigator. Abnormalities of serum glucose, serum lipids, urinary glucose, and urinary protein consistent with T2DM are acceptable. Exclusion Criteria: Have significant history of, or current, cardiovascular, respiratory, hepatic (applies to Group 1 only), renal, GI, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs Have a history or presence of pancreatitis, elevation in serum amylase or lipase (greater than 1.5-fold ULN) or GI disorder or any GI disease, which impacts gastric emptying Have any abnormality in the 12-lead ECG at screening Have severe atopy or have a history of clinically significant multiple or severe drug allergies or severe post treatment hypersensitivity reactions Have a history of, or current psychiatric disorders Have any one of the following: a marked baseline prolongation of QT/QTc interval as determined, for example, from a QTc interval greater than 480 ms a history of additional risk factors for Torsades de Pointes for example, heart failure, hypokalemia, family history of Long QT Syndrome, or use concomitant medications that prolong the QT/QTc interval. Women who are pregnant, intend to become pregnant or are breastfeeding a child are not eligible to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 (Mild Hepatic Impairment)<br>LY3502970 administered orally. | Drug: LY3502970<br>* Administered orally.<br>|
| Experimental: LY3502970 (Moderate Hepatic Impairment)<br>LY3502970 administered orally. | Drug: LY3502970<br>* Administered orally.<br>|
| Experimental: LY3502970 (Severe Hepatic Impairment)<br>LY3502970 administered orally. | Drug: LY3502970<br>* Administered orally.<br>|
| Experimental: LY3502970 (Normal Hepatic Function)<br>LY3502970 administered orally. | 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 96 hours 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 96 hours postdose | 
| PK: Maximum observed concentration (Cmax) of LY3502970 | PK: Cmax of LY3502970 | Predose up to 96 hours postdose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LY3502970, Pharmacokinetics Hepatic Impairment, GLP-1 Receptor Non-peptide agonist (GLP-1 NPA)