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Recruiting NCT06920043

A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH

Phase II Interventional Metabolic Dysfunction-Associated Steatohepatitis Non-alcoholic Fatty Liver Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Efimosfermin, Placebo.
Who it may be relevant to
Registry conditions: Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2, Randomized, Double-blinded, Placebo-controlled Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)

Overview

The purpose of this study is to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of efimosfermin in participants with metabolic dysfunction associated steatohepatitis (MASH) and compensated cirrhosis consistent with stage F4 fibrosis.

Interventions

  • Drug Efimosfermin
    Efimosfermin will be administered as a subcutaneous injection.
  • Drug Placebo
    Placebo will be administered as a subcutaneous injection.

Primary outcome measures

  • Number of participants with treatment emergent adverse events (TEAEs) [Time frame: From Day 1 to 100 weeks]
Secondary outcome measures (5)
  • Serum concentrations of efimosfermin [Time frame: Up to Week 21]
  • Maximum serum drug concentration (Cmax) of efimosfermin [Time frame: Up to Week 21]
  • Area under the serum concentration-time curve (AUC) of efimosfermin [Time frame: Up to Week 21]
  • Average serum drug concentration (Cavg) of efimosfermin [Time frame: Up to Week 21]
  • Concentration of study drug at the end of the dosing interval (Ctrough) of efimosfermin [Time frame: Up to Week 21]

Eligibility criteria

Inclusion criteria

  • Ability to understand and sign a written informed consent form (ICF)
  • Age 18 through 75 years at enrollment
  • History or presence of 2 or more of the 5 components of metabolic syndrome
  • Liver biopsy confirmation of MASH consistent with stage F4 fibrosis
  • Other inclusion criteria may apply.

Exclusion criteria

  • Individuals with chronic liver disease from other causes, or any history or evidence of decompensated liver disease
  • History of type 1 diabetes
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 × the upper limit of normal (ULN)
  • Other exclusion criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 30 centers
  • GSK Investigational Site — Chandler
  • GSK Investigational Site — Mesa
  • GSK Investigational Site — Tucson
  • GSK Investigational Site — Fresno
  • GSK Investigational Site — Lancaster
  • GSK Investigational Site — Pasadena
  • GSK Investigational Site — Rialto
  • GSK Investigational Site — Santa Maria
  • … and 22 more centers

Identifiers

NCT: NCT06920043 · 306301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗