In the phase 2b ENLIVEN trial, the investigational drug pegozafermin met both primary endpoints at 24 weeks and led to improvements in fibrosis, paving the way for phase 3 development.
=.008), 22% and 7% for 44-mg Q2W, 30-mg QW, 15-mg QW, and placebo, respectively. The proportions of participants who achieved resolution of NASH without worsening of fibrosis were 26%, 23%, 37%, and 2% , respectively.
Loomba and his colleagues also evaluated the proportion who achieved both improvement in fibrosis and NAS resolution and found that 20% of the 44-mg Q2W and 14% of the 30-mg QW satisfied this, while none of the participants who received placebo did. They also analyzed the proportion of participants who achieved at least a 2-point improvement in NAS, MRI proton density fat fraction response, and ALT response and found that 52% and 60% did, respectively.
"In patients on pegozafermin, robust reduction in liver fat was seen with high responder rates according to MRI-PDFF at week 24," said Loomba. Reductions of 55%, 50%, and 15% were seen with 44-mg Q2W, 30-mg QW, and placebo."Super-responders with over 50% reduction in liver fat were also identified in 67% and 66% and in 44-mg Q2W and 30-mg QW respectively."
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