A Study Evaluating the Efficacy and Safety of Pegozafermi... | NCT06318169 | Trialant

A Study Evaluating the Efficacy and Safety of Pegozafermi... | NCT06318169 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pegozafermin Regimen 1	Experimental		Biological: Pegozafermin
Pegozafermin Regimen 2	Experimental		Biological: Pegozafermin
Placebo	Placebo Comparator	Matched Placebo will be administered in Regimens 1 and 2.	Other: Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52	Worsening of steatohepatitis is defined as increase in non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) for ballooning, inflammation, or steatosis	Week 52
Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52	Resolution of steatohepatitis is defined as total absence of ballooning (score=0) and absent or mild inflammation (score 0 to 1). Worsening of fibrosis is defined as progression of fibrosis by ≥1 stage.	Week 52
Time to First Occurrence of Disease Progression	Final analysis of the time to first occurrence of disease progression will be measured by a composite of protocol-specified clinical events	Up to 5 years

Secondary Outcomes

Measure	Description	Time Frame
Percent Change from Baseline in Alanine Aminotransferase at Week 52		Baseline, Week 52
Absolute Change From Baseline in Enhanced Liver Fibrosis (ELF) Score at Week 52		Baseline, Week 52

Contacts/Locations Module