Back to resultsA Study of LY3437943 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
LY3437943
Sponsored by
About this trial
This is an interventional basic science trial for Healthy focused on measuring Pharmacokinetics, Hepatic Impairment
Eligibility Criteria
Inclusion Criteria: All Participants: Have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²), inclusive Healthy or various degrees of hepatic impairment depending on the study group Exclusion Criteria: Participants with hepatic impairment: Have or are anticipating an organ transplant within the next 6 months Requires needle evacuation of ascites fluid more than 2 times per month Have had variceal bleeding within 3 months of check-in, unless the participant has undergone a successful banding procedure; in that case, may check-in from 1 month after the banding procedure
Sites / Locations
- Accel Research Sites- Clinical Research UnitRecruiting
- Advanced Pharma Clinical ResearchRecruiting
- 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
LY3437943 (Normal Hepatic Function)
LY3437943 (Severe Hepatic Impairment)
LY3437943 (Moderate Hepatic Impairment)
LY3437943 (Mild Hepatic Impairment)
Arm Description
LY3437943 administered subcutaneously (SC).
LY3437943 administered SC.
LY3437943 administered SC.
LY3437943 administered SC.
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
1. Study Identification
Unique Protocol Identification Number
NCT05916560
Brief Title
A Study of LY3437943 in Participants With Impaired and Normal Liver Function
Official Title
A Parallel-Group, Single-Dose, Phase 1, Open-Label Study to Investigate the Pharmacokinetics of LY3437943 in Participants With Hepatic Impairment Compared With Healthy Participants
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
July 17, 2024 (Anticipated)
Study Completion Date
July 17, 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 LY3437943 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 healthy participants with normal liver function. The safety and tolerability of LY3437943 will also be evaluated. The study may last up to 9 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
Pharmacokinetics, Hepatic Impairment
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LY3437943 (Normal Hepatic Function)
Arm Type
Experimental
Arm Description
LY3437943 administered subcutaneously (SC).
Arm Title
LY3437943 (Severe Hepatic Impairment)
Arm Type
Experimental
Arm Description
LY3437943 administered SC.
Arm Title
LY3437943 (Moderate Hepatic Impairment)
Arm Type
Experimental
Arm Description
LY3437943 administered SC.
Arm Title
LY3437943 (Mild Hepatic Impairment)
Arm Type
Experimental
Arm Description
LY3437943 administered SC.
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 30 days postdose
Title
PK: Maximum observed concentration (Cmax) of LY3437943
Description
PK: Cmax of LY3437943
Time Frame
Predose up to 30 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:
All Participants:
Have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²), inclusive
Healthy or various degrees of hepatic impairment depending on the study group
Exclusion Criteria:
Participants with hepatic impairment:
Have or are anticipating an organ transplant within the next 6 months
Requires needle evacuation of ascites fluid more than 2 times per month
Have had variceal bleeding within 3 months of check-in, unless the participant has undergone a successful banding procedure; in that case, may check-in from 1 month after the banding procedure
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
Accel Research Sites- Clinical Research Unit
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
386-785-2400
First Name & Middle Initial & Last Name & Degree
Bruce G Rankin
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
(305) 220-2727 Ext. 864
First Name & Middle Initial & Last Name & Degree
Kimberly Cruz
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
Learn more about this trial
A Study of LY3437943 in Participants With Impaired and Normal Liver Function
We'll reach out to this number within 24 hrs