A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGlaxoSmithKline
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Efimosfermin
DrugEfimosfermin will be administered as a subcutaneous injection.
Placebo
DrugPlacebo will be administered as a subcutaneous injection.
Treatment groups
42 Participants
are divided into 3 treatment groupsGroup A: Efimosfermin (Dose 1)Experimental treatment 1 intervention
Group B: Efimosfermin (Dose 2)Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with treatment emergent adverse events (TEAEs)
To assess the effects of efimosfermin on safety and tolerability.
Time frame
From Day 1 to 100 weeksSecondary outcomes
1
Serum concentrations of efimosfermin
To assess the steady-state PK of efimosfermin.
Time frame
Up to Week 212
Maximum serum drug concentration (Cmax) of efimosfermin
To assess the steady-state PK of efimosfermin.
Time frame
Up to Week 213
Area under the serum concentration-time curve (AUC) of efimosfermin
To assess the steady-state PK of efimosfermin.
Time frame
Up to Week 214
Average serum drug concentration (Cavg) of efimosfermin
To assess the steady-state PK of efimosfermin.
Time frame
Up to Week 21Sponsors and contacts
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Source ClinicalTrials.gov