NCT07358546

A Study of Efimosfermin Alfa in Adults With Hepatic Impairment

A Phase 1, Open-label, Single-dose Study to Evaluate the Pharmacokinetics and Safety of Efimosfermin Alfa in Adults With Varying Degrees of Hepatic Impairment Due to Steatotic Liver Disease

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to study the pharmacokinetic (PK) and safety profiles of a single dose of efimosfermin alfa in participants with varying degrees of Hepatic Impairment (HI) (assessed by Child-Pugh score) due to steatotic liver disease, with and without significant alcohol consumption.

Conditions

• Non-alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	Efimosfermin alfa	Efimosfermin alfa to be administrated subcutaneously

Timeline

• Start date: 2026-03-13
• Primary completion: 2027-10-13
• Completion: 2027-10-13
• First posted: 2026-01-22
• Last updated: 2026-04-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study