Study record · Pemvidutide
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.
Key result
MASH resolution 58% and 52% vs 20% placebo; fibrosis improvement 33% and 36% vs 28% placebo and was not statistically significant.
Study details
Study designRandomized, double-blind, placebo-controlled trial
PhasePhase 2b
PopulationAdults with biopsy-confirmed F2/F3 MASH
Sample size212
RouteSubcutaneous
Regimen / exposure1.2 or 1.8 mg weekly without titration
Duration24-week biopsy primary analysis; 48-week study
ComparatorPlacebo
Primary endpoint / questionMASH resolution without fibrosis worsening; fibrosis improvement without MASH worsening
Safety resultAEs 78%, 81%, 67% placebo; mostly mild/moderate; very low AE-related discontinuation.
Key limitationsOne primary endpoint met while fibrosis endpoint did not at 24 weeks; longer follow-up and Phase 3 required.
Registry / identifierNCT05989711