A Study of LY3437943 in Participants With Impaired and Normal Liver Function

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05916560

Collaborator

(none)

Enrollment

Locations

Arms

10.6

Anticipated Duration (Months)

9.3

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Hepatic Insufficiency	Drug: LY3437943	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

37 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Anticipated Study Start Date :

Jun 30, 2023

Anticipated Primary Completion Date :

May 19, 2024

Anticipated Study Completion Date :

May 19, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3437943 (Normal Hepatic Function) LY3437943 administered subcutaneously (SC).	Drug: LY3437943 Administered SC.
Experimental: LY3437943 (Severe Hepatic Impairment) LY3437943 administered SC.	Drug: LY3437943 Administered SC.
Experimental: LY3437943 (Moderate Hepatic Impairment) LY3437943 administered SC.	Drug: LY3437943 Administered SC.
Experimental: LY3437943 (Mild Hepatic Impairment) LY3437943 administered SC.	Drug: LY3437943 Administered SC.

Outcome Measures

Primary Outcome Measures

Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3437943 [Predose up to 30 days postdose]
PK: AUC0-∞ of LY3437943
PK: Maximum observed concentration (Cmax) of LY3437943 [Predose up to 30 days postdose]
PK: Cmax of LY3437943

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Accel Research Sites- Clinical Research Unit	DeLand	Florida	United States	32720
2	Advanced Pharma Clinical Research	Miami	Florida	United States	33147-4040
3	American Research Corporation at Texas Liver Institute	San Antonio	Texas	United States	78215
4	Pinnacle Clinical Research	San Antonio	Texas	United States	78229

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director: 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), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT05916560

Other Study ID Numbers:

18531
J1I-MC-GZBT

First Posted:

Jun 23, 2023

Last Update Posted:

Jun 23, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Eli Lilly and Company

Pharmacokinetics

Hepatic Impairment

Additional relevant MeSH terms:

Hepatic Insufficiency

Liver Failure

Study Results

No Results Posted as of Jun 23, 2023