LY3437943 for Liver Function

Recruiting at 5 trial locations

Overseen By Madhavi Rudraraju

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Disqualifiers: Organ transplant, Ascites, Variceal bleeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

43 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

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)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for people with different levels of liver function, from healthy to severely impaired. Participants should have a body mass index (BMI) between 19.0 and 42.0 kg/m².

Inclusion Criteria

I am healthy or have liver issues depending on the study's needs.

All Participants must have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²), inclusive

Exclusion Criteria

I have liver issues and am expecting a transplant soon.

I don't need a procedure to remove excess belly fluid more than twice a month.

I haven't had variceal bleeding in the last 3 months, or if I did, it was successfully treated over a month ago.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of LY3437943 administered subcutaneously

1 day

Follow-up

Participants are monitored for safety and pharmacokinetics of LY3437943

4 weeks

Treatment Details

Interventions

• LY3437943

Trial Overview The study tests LY3437943 in individuals to see how much gets into the blood and how long it stays there across varying degrees of liver health. It also assesses the drug's safety over up to a nine-week period.

Participant Groups

Group I: LY3437943 (Severe Hepatic Impairment) Experimental Treatment 1 Intervention

LY3437943 administered SC.

Group II: LY3437943 (Normal Hepatic Function) Experimental Treatment 1 Intervention

LY3437943 administered subcutaneously (SC).

Group III: LY3437943 (Moderate Hepatic Impairment) Experimental Treatment 1 Intervention

LY3437943 administered SC.

Group IV: LY3437943 (Mild Hepatic Impairment) Experimental Treatment 1 Intervention

LY3437943 administered SC.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University