A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
NCT07358546 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2026-04-13
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
- DRUG
-
Efimosfermin alfa
Efimosfermin alfa to be administrated subcutaneously
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-13
- Primary Completion
- 2027-10-13
- Completion
- 2027-10-13
- FDA Drug
- Yes
Countries
- United States
Study Locations
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