IMPACT Phase 2b trial in MASH
MASH resolution 58% and 52% vs 20% placebo; fibrosis improvement 33% and 36% vs 28% placebo and was not statistically significant.
What this study tells us
Participants were assigned to comparison groups by chance, usually with placebo and/or blinding to reduce bias. This is a strong design for testing cause and effect, but the population, duration and endpoints still limit what can be concluded.
Adults with biopsy-confirmed F2/F3 MASH
n=212
MASH resolution 58% and 52% vs 20% placebo; fibrosis improvement 33% and 36% vs 28% placebo and was not statistically significant.
One primary endpoint met while fibrosis endpoint did not at 24 weeks; longer follow-up and Phase 3 required.
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Key result
MASH resolution 58% and 52% vs 20% placebo; fibrosis improvement 33% and 36% vs 28% placebo and was not statistically significant.