NCT07165002

A Study of the Pharmacokinetics and Safety of LY3537031 in Participants With Normal Liver Function and With Mild, Moderate, or Severe Liver Impairment

A Phase 1, Multicenter, Parallel-Design, Single-Dose, Open-Label Study to Evaluate the Pharmacokinetics and Safety of LY3537031 in Participants With Normal Hepatic Function and Participants With Mild, Moderate, or Severe Hepatic Impairment

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to measure how much LY3537031 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function and in healthy participants with normal liver function. The safety and tolerability of LY3537031 will also be evaluated. The study drug will be administered subcutaneously (SC) (under the skin).

Conditions

• Healthy
• Hepatic Insufficiency

Interventions

Type	Name	Description
DRUG	LY3537031	Administered SC

Timeline

• Start date: 2025-10-20
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-09-10
• Last updated: 2025-12-04

Locations

3 sites across 3 countries: Hungary, New Zealand, Slovakia

Regulatory

• FDA-regulated drug study