A Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Compared With Placebo in Adult Participants With Alcohol-related Liver Disease (ALD)

Part of paid clinical trials in Topeka, Kansas.

Sponsor
GlaxoSmithKline
Study ID
NCT07791043
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Liver Diseases, Alcoholic

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Efimosfermin alfa — DRUG
    Efimosfermin alfa will be administered.
  • Placebo — DRUG
    Placebo will be administered.

Study Details

This is a dose-ranging study to evaluate safety of efimosfermin alfa and to establish proof-of-concept that efimosfermin alfa therapy provides benefit in participants with ALD.

Key Dates

First listed
Aug 27, 2026
Start date
Aug 31, 2026
Status verified
Sep 2026
Primary completion
Aug 11, 2028
Completion
Jan 14, 2030

Study Design

Enrollment
274 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Efimosfermin alfa Dose Level 1
    Participants will receive efimosfermin alfa dose level 1.
  • Experimental: Efimosfermin alfa Dose Level 2
    Participants will receive efimosfermin alfa dose level 2.
  • Experimental: Efimosfermin alfa Dose Level 3
    Participants will receive efimosfermin alfa dose level 3.
  • Placebo Comparator: Placebo
    Participants will receive placebo.

Primary Outcome Measure

Change from Baseline in vibration-controlled transient elastography-liver stiffness measurement (VCTE-LSM) [ Time Frame: Baseline (Day 1) and up to Week 60 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteTopekaKansas66606
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Shekhar Challa (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteFort WorthTexas76104
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Thomas Cotter (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 Topeka, KS

By research site
GSK Investigational Site· Topeka, KSGSK Investigational Site· Fort Worth, TXGSK Investigational Site· San Antonio, TX

Related Studies