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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05916560
• Other study ID #: 18531
• Secondary ID: J1I-MC-GZBT
• Status: Recruiting
• Phase: Phase 1
• Start date: July 13, 2023
• Est. completion date: November 2024

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]Lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Hepatic Insufficiency
• Liver Failure

Intervention

Drug:
• LY3437943
Administered SC.

Locations

Country	Name	City	State
United States	Accel Research Sites- Clinical Research Unit	DeLand	Florida
United States	Advanced Pharma Clinical Research	Miami	Florida
United States	American Research Corporation at Texas Liver Institute	San Antonio	Texas
United States	Pinnacle Clinical Research	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-8) of LY3437943	PK: AUC0-8 of LY3437943	Predose up to 30 days postdose
Primary	PK: Maximum observed concentration (Cmax) of LY3437943	PK: Cmax of LY3437943	Predose up to 30 days postdose