A Study of Efimosfermin Alfa in Adults With Hepatic Impairment

Part of paid clinical trials in Rialto, California.

Sponsor
GlaxoSmithKline
Study ID
NCT07358546
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Non-alcoholic Fatty Liver Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Efimosfermin alfa — DRUG
    Efimosfermin alfa to be administrated subcutaneously

Study Details

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.

Key Dates

Start date
Mar 13, 2026
Status verified
May 2026
Primary completion
Oct 13, 2027
Completion
Oct 13, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Efimosfermin alfa in participants with moderate hepatic impairment due to MASH without alcohol
    All participants will receive efimosfermin alfa. Participants will have moderate hepatic impairment (Child-Pugh B) due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) with typical alcohol consumption threshold in the 3 months prior to Screening of less than (\<) 5 standard drinks on any day and \<15 standard drinks per week for men; or \<4 standard drinks on any day and \<8 standard drinks per week for women.
  • Experimental: Efimosfermin alfa in participants with moderate hepatic impairment due to MASH with alcohol
    All participants will receive efimosfermin alfa. Participants will have moderate hepatic impairment (Child-Pugh B) due to MASH with typical alcohol consumption threshold in the 3 months prior to Screening of greater than or equal to (\>=) 5 standard drinks per day or \>=15 standard drinks per week for men; or \>= 4 standard drinks per day or \>=8 or more drinks per week for women.
  • Experimental: Efimosfermin alfa in severe hepatic impairment participants due to MASH regardless of alcohol use
    All participants will receive efimosfermin alfa. Participants will have severe hepatic impairment (Child-Pugh C) due to MASH with any typical daily alcohol consumption.

Primary Outcome Measure

Area under the serum drug concentration versus time curve from time zero to infinity (AUC[0-inf]) of efimosfermin alfa [ Time Frame: Up to 90 Days ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteRialtoCalifornia92377
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Zeid Kayali (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteTampaFlorida33603
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Jesus Navarro (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteSan AntonioTexas78215
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Eric Lawitz (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rialto, CA

By research site
GSK Investigational Site· Rialto, CAGSK Investigational Site· Tampa, FLGSK Investigational Site· San Antonio, TX

Related Studies