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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
274
Efimosfermin alfa will be administered.
Placebo will be administered.
GSK Investigational Site
Topeka, Kansas, United States
RECRUITINGGSK Investigational Site
Fort Worth, Texas, United States
RECRUITINGGSK Investigational Site
San Antonio, Texas, United States
RECRUITINGChange from Baseline in vibration-controlled transient elastography-liver stiffness measurement (VCTE-LSM)
VCTE-LSM is a non-invasive test that uses vibration-controlled transient elastography to measure the stiffness of the liver in kilopascals (kPa)
Time frame: Baseline (Day 1) and up to Week 60
Change from Baseline in model for end-stage liver disease (MELD) score
MELD is a scoring system for assessing the severity of chronic liver disease. MELD scores range between 6 and 40, with 40 being the most severe.
Time frame: Baseline (Day 1) and up to Week 60
Change from Baseline in serum aspartate aminotransferase (AST) (International units per liter)
This is a measurement of the AST enzyme in the blood.
Time frame: Baseline (Day 1) and up to Week 60
Change from Baseline in a blood test that helps predict the risk of disease progression in liver disease
Time frame: Baseline (Day 1) and up to Week 52
Trough Concentration at steady state (Ctrough,ss) following administration of efimosfermin alfa
Time frame: Up to Week 56
Area Under the concentration-time Curve from Time 0 (pre-dose) to the last quantifiable concentration (AUC[0-t]) of efimosfermin alfa in the subset of participants with optional intensive pharmacokinetics (PK) sampling
Time frame: Up to Week 4
Maximum observed drug concentration (Cmax) of efimosfermin alfa in the subset of participants with optional intensive PK sampling
Time frame: Up to Week 4
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Number of Participants with Anti-drug antibodies (ADA) against efimosfermin alfa
Time frame: Up to Week 56
Number of participants with treatment-emergent adverse events (TEAEs) and TEAEs by severity
Time frame: Up to Week 60
Number of participants with TEAEs leading to discontinuation and TEAEs leading to discontinuation by severity
Time frame: Up to Week 60
Number of participants with Grade 3 and Grade 4 laboratory abnormalities
Time frame: Up to Week 60
Number of participants with clinically significant changes in Vital signs
Time frame: Up to Week 60
Number of participants with clinically significant changes in 12-lead electrocardiogram (ECG) findings
Time frame: Up to Week 60