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

Nonalcoholic Steatohepatitis (NASH) Clinical Trial

Official title:
A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial of ADI-PEG 20 or Placebo in Subjects With Nonalcoholic Steatohepatitis (NASH)

Clinical Trial Summary

Evaluate efficacy and safety of ADI-PEG 20 in patients with NASH

Clinical Trial Description

The safety of ADI-PEG 20 will be assessed during the study through the reporting of adverse events (AEs), clinical laboratory tests, electrocardiogram (ECG), vital sign assessments, body weight, and concomitant medication usage. An external Data Safety and Monitoring Committee (DSMB) that consists of two hepatologists and a statistician will review the safety of the study. The DSMB will convene after 10 subjects (approximately 5 per treatment group) have completed the Week 4 assessments. The DSMB will receive all reports of serious adverse events (SAEs) and convene as needed to monitor for safety. The primary efficacy will be assessed via the absolute change from baseline in hepatic fat fraction measured by MRI-PDFF at Week 24. ;

Study Design

Related Conditions & MeSH terms

  • Fatty Liver
  • Non-alcoholic Fatty Liver Disease
  • Nonalcoholic Steatohepatitis (NASH)
Clinical Trial Details
NCT number NCT05842512
Study type Interventional
Source Polaris Group
Contact Silvia Lee
Phone 02-2656-2727
Email silvialee@polarispharma.com
Status Recruiting
Phase Phase 2
Start date September 13, 2023
Completion date January 31, 2028
View Details
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