Overview
- The Lancet-published Phase IIb trial enrolled 160 adults with biopsy-confirmed MASH across 43 sites in the United States and Puerto Rico.
- Monthly subcutaneous dosing up to 120 mg produced improvement in nearly 60% of patients at the highest dose versus 19% on placebo, without worsening fibrosis.
- ION224 inhibits the liver enzyme DGAT2, directly targeting hepatic fat production and storage as a mechanistically distinct approach.
- Investigators reported frequent adverse events in both arms but no deaths or treatment-related serious adverse events, indicating acceptable tolerability.
- Efficacy occurred independent of weight change, supporting potential combination with GLP-1–based weight-loss therapies as the field evolves after resmetirom’s 2024 approval.