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

Primary Purpose

Healthy, Renal Insufficiency

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY3437943
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

Eligibility Criteria

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

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

Sites / Locations

  • Orange County Research Center
  • Clinical Pharmacology of Miami
  • Orlando Clinical Research Center
  • Nucleus Networks

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

LY3437943 (Control)

LY3437943 (Severe Renal Impairment)

LY3437943 (End-Stage Renal Disease)

Arm Description

LY3437943 administered subcutaneous (SC) to participants with normal renal function

LY3437943 administered SC to participants with severe renal impairment

LY3437943 administered SC to participants with end-stage renal disease

Outcomes

Primary Outcome Measures

Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3437943
PK: AUC0-∞ of LY3437943
PK: Maximum observed concentration (Cmax) of LY3437943
PK: Cmax of LY3437943

Secondary Outcome Measures

Full Information

First Posted
November 3, 2022
Last Updated
September 29, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05611957
Brief Title
A Study of LY3437943 in Healthy Participants and Participants With Impaired Renal Function
Official Title
A Parallel-group, Phase 1, Open-label Study to Investigate the Pharmacokinetics of LY3437943 in Participants With Renal Impairment Compared With Healthy Participants
Study Type
Interventional

2. Study Status

Record Verification Date
September 15, 2023
Overall Recruitment Status
Completed
Study Start Date
November 16, 2022 (Actual)
Primary Completion Date
September 5, 2023 (Actual)
Study Completion Date
September 5, 2023 (Actual)

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 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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
LY3437943 (Control)
Arm Type
Experimental
Arm Description
LY3437943 administered subcutaneous (SC) to participants with normal renal function
Arm Title
LY3437943 (Severe Renal Impairment)
Arm Type
Experimental
Arm Description
LY3437943 administered SC to participants with severe renal impairment
Arm Title
LY3437943 (End-Stage Renal Disease)
Arm Type
Experimental
Arm Description
LY3437943 administered SC to participants with end-stage renal disease
Intervention Type
Drug
Intervention Name(s)
LY3437943
Intervention Description
Administered SC.
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3437943
Description
PK: AUC0-∞ of LY3437943
Time Frame
Predose up to 31 days postdose
Title
PK: Maximum observed concentration (Cmax) of LY3437943
Description
PK: Cmax of LY3437943
Time Frame
Predose up to 31 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: 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
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
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Clinical Pharmacology of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33014-3616
Country
United States
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Nucleus Networks
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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