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

Primary Purpose

Renal Insufficiency, Healthy

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 Renal Insufficiency

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical Pharmacology of MiamiRecruiting
  • Advanced Pharma Clinical ResearchRecruiting
  • Orlando Clinical Research CenterRecruiting
  • Alliance For multispecialty Research, LLCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

LY3502970 (Control)

LY3502970 (Severe Renal Impairment)

LY3502970 (End-Stage Renal Disease)

Arm Description

LY3502970 administered orally to participants with normal renal function

LY3502970 administered orally to participants with severe renal impairment

LY3502970 administered orally to participants with end-stage renal disease (ESRD)

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
June 30, 2023
Last Updated
October 18, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05936138
Brief Title
A Study of LY3502970 in Participants With Normal and Impaired Renal Function
Official Title
A Phase 1, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Renal Function and Participants With Renal Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2023 (Actual)
Primary Completion Date
November 11, 2023 (Anticipated)
Study Completion Date
November 11, 2023 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Healthy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
LY3502970 (Control)
Arm Type
Experimental
Arm Description
LY3502970 administered orally to participants with normal renal function
Arm Title
LY3502970 (Severe Renal Impairment)
Arm Type
Experimental
Arm Description
LY3502970 administered orally to participants with severe renal impairment
Arm Title
LY3502970 (End-Stage Renal Disease)
Arm Type
Experimental
Arm Description
LY3502970 administered orally to participants with end-stage renal disease (ESRD)
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 12 days 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 12 days postdose
Title
PK: Maximum observed concentration (Cmax) of LY3502970
Description
PK: Cmax of LY3502970
Time Frame
Predose up to 12 days postdose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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
Advanced Pharma Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33147-4040
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
+1 305-220-2727 ext 864
First Name & Middle Initial & Last Name & Degree
Kimberly Cruz
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
407-475-0227
First Name & Middle Initial & Last Name & Degree
Thomas Marbury
Facility Name
Alliance For multispecialty Research, LLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
+1 865-305-9100 x2246
First Name & Middle Initial & Last Name & Degree
William Smith

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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