Primary Opjective: To evaluate the effect of pegozafermin compared to placebo on liver histology at 52 weeks relative to baseline biopsy Key Secondary Objective: To evaluate the effect of pegozafermin compared to placebo on liver-related noninvasive tests (NITs) at 52 weeks Secondary objectives: To evaluate the effect of pegozafermin compared to placebo on additional liver histology endpoints at 52 weeks relative to baseline biopsy To evaluate the effect of pegozafermin compared to placebo on additional NITs at 52 weeks To evaluate the metabolic effects of pegozafermin compared to placebo at 52 weeks To evaluate the safety and tolerability of pegozafermin compared to placebo after 52 weeks of treatment Exploratory objectives: To evaluate the effect of pegozafermin compared to placebo on additional clinical parameters, including histology, imaging assessments, anthropometric assessment, and laboratory parameters at 52 weeks To evaluate the effects of pegozafermin on patient reported outcomes (PROs) from baseline to 52 weeks To evaluate the pharmacokinetics (PK) of pegozafermin over 52 weeks of treatment To evaluate additional safety and tolerability profile of pegozafermin over 52 weeks of treatment To evaluate the effect of pegozafermin on blood pressure and pulse rate after 48 weeks of treatment (Ambulatory Blood Pressure Monitoring [ABPM] substudy) To characterize the immunogenicity of pegozafermin after 52 weeks of treatment To evaluate the molecular data (e.g., proteomics, genomics) to increase the understanding of pegozafermin biological activity, and to identify potential existing and/or emerging biomarkers
What is the full name of this clinical trial?
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Metabolic Dysfunction-Associated Steatohepatitis and Fibrosis.