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

Primary Purpose

Healthy, Hepatic Insufficiency

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY3502970
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring LY3502970, Pharmacokinetics Hepatic Impairment, GLP-1 Receptor Non-peptide agonist (GLP-1 NPA)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical Pharmacology of MiamiRecruiting
  • Orlando Clinical Research CenterRecruiting
  • American Research Corporation at Texas Liver InstituteRecruiting
  • Pinnacle Clinical ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

LY3502970 (Mild Hepatic Impairment)

LY3502970 (Moderate Hepatic Impairment)

LY3502970 (Severe Hepatic Impairment)

LY3502970 (Normal Hepatic Function)

Arm Description

LY3502970 administered orally.

LY3502970 administered orally.

LY3502970 administered orally.

LY3502970 administered orally.

Outcomes

Primary Outcome Measures

Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3502970
PK: AUC0-∞ of LY3502970
PK: Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3502970
PK: AUC0-tlast of LY3502970
PK: Maximum observed concentration (Cmax) of LY3502970
PK: Cmax of LY3502970

Secondary Outcome Measures

Full Information

First Posted
May 22, 2023
Last Updated
October 5, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05882032
Brief Title
A Study of LY3502970 in Participants With Impaired and Normal Liver Function
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2023 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Hepatic Insufficiency
Keywords
LY3502970, Pharmacokinetics Hepatic Impairment, GLP-1 Receptor Non-peptide agonist (GLP-1 NPA)

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LY3502970 (Mild Hepatic Impairment)
Arm Type
Experimental
Arm Description
LY3502970 administered orally.
Arm Title
LY3502970 (Moderate Hepatic Impairment)
Arm Type
Experimental
Arm Description
LY3502970 administered orally.
Arm Title
LY3502970 (Severe Hepatic Impairment)
Arm Type
Experimental
Arm Description
LY3502970 administered orally.
Arm Title
LY3502970 (Normal Hepatic Function)
Arm Type
Experimental
Arm Description
LY3502970 administered orally.
Intervention Type
Drug
Intervention Name(s)
LY3502970
Intervention Description
Administered orally.
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3502970
Description
PK: AUC0-∞ of LY3502970
Time Frame
Predose up to 96 hours postdose
Title
PK: Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3502970
Description
PK: AUC0-tlast of LY3502970
Time Frame
Predose up to 96 hours postdose
Title
PK: Maximum observed concentration (Cmax) of LY3502970
Description
PK: Cmax of LY3502970
Time Frame
Predose up to 96 hours postdose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@Lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Pharmacology of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
305-817-2900
First Name & Middle Initial & Last Name & Degree
Alexander Prezioso
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
407-240-7878
First Name & Middle Initial & Last Name & Degree
Thomas Marbury
Facility Name
American Research Corporation at Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
210-253-3426
First Name & Middle Initial & Last Name & Degree
Eric Lawitz
Facility Name
Pinnacle Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
210-982-0320
First Name & Middle Initial & Last Name & Degree
Madhavi Rudraraju

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://trials.lilly.com/en-US/trial/407541
Description
A Study of LY3502970 in Participants With Impaired and Normal Liver Function

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