Phase 2A Study of ADI-PEG 20 Compared to Placebo for Treatment of Nonalcoholic Steatohepatitis NASH in Adults

What this Trial Is About

Researchers are evaluating the safety and effectiveness of ADI-PEG 20 in adults with Nonalcoholic Steatohepatitis NASH, a liver condition characterized by fat buildup and inflammation. This phase 2A clinical trial compares ADI-PEG 20 with a placebo to understand its impact on liver fat reduction. The study includes careful monitoring of side effects and laboratory tests to ensure participant safety. Participants receive weekly doses of ADI-PEG 20 or placebo via intramuscular injection at 36 mgm2. The trial is randomized and double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts 24 weeks, during which liver fat changes are assessed using MRI-PDFF imaging. An independent committee oversees safety by reviewing adverse events and clinical data. During the study, participants undergo regular health evaluations including vital signs, body weight checks, ECGs, and blood tests. Liver fat levels are measured at the start and at week 24 to assess treatment effects. Safety is monitored continuously through adverse event reporting and laboratory tests. The total participation time spans 24 weeks, with ongoing review of safety and efficacy outcomes throughout.

Study of ADI-PEG 20 Versus Placebo in Subjects With NASH