Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
Conditions
Keywords
Fibroblast growth factor, Stage 4 fibrosis, Compensated Cirrhosis
Brief summary
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
DRUGEfimosfermin
Efimosfermin will be administered as a subcutaneous injection.
DRUGPlacebo
Placebo will be administered as a subcutaneous injection.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment emergent adverse events (TEAEs) | From Day 1 to 100 weeks | To assess the effects of efimosfermin on safety and tolerability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum concentrations of efimosfermin | Up to Week 21 | To assess the steady-state PK of efimosfermin. |
| Maximum serum drug concentration (Cmax) of efimosfermin | Up to Week 21 | To assess the steady-state PK of efimosfermin. |
| Area under the serum concentration-time curve (AUC) of efimosfermin | Up to Week 21 | To assess the steady-state PK of efimosfermin. |
| Average serum drug concentration (Cavg) of efimosfermin | Up to Week 21 | To assess the steady-state PK of efimosfermin. |
| Concentration of study drug at the end of the dosing interval (Ctrough) of efimosfermin | Up to Week 21 | To assess the steady-state PK of efimosfermin. |
Countries
United States
Contacts
CONTACTUS GSK Clinical Trials Call Center
CONTACTEU GSK Clinical Trials Call Center
Outcome results
None listed