Hepion Pharmaceuticals, Inc. announced that it has completed enrollment of 60 NASH stage 3 subjects in the Phase 2 ALTITUDE-NASH clinical trial. The trial is being conducted in collaboration with HepQuant, LLC and Summit Clinical Research, at 20 sites within Summit's Integrated Research Organization. ALTITUDE-NASH is a Phase 2, randomized, multi-center, open-label study designed to evaluate the safety and efficacy of rencofilstat on hepatic function and numerous NASH biomarkers after four months of dosing.

Subjects enrolled in the trial were classified as NASH stage F3 based on either historical biopsy or by using the AGILE 3+ criteria, defined by a screening Fibroscan score alongside common clinical and laboratory parameters. Subjects are randomized to receive a once daily, oral dose of 75, 150, or 225 mg rencofilstat soft gelatin capsules (20 subjects in each dosing cohort) over a period of four months. The HepQuant 'SHUNT' test, a measure of hepatic function, will be performed at baseline, and changes in the Disease Severity Index score relative to baseline measurements will be determined at days 60 and 120.

Other NASH biomarkers will be collected throughout the study duration.