Study record · Survodutide
A Phase 2 Randomized Trial of Survodutide in MASH and Fibrosis
Primary response 47%, 62%, 43% vs 14% placebo; ≥1-stage fibrosis improvement 34%, 36%, 34% vs 22%.
Key result
Primary response 47%, 62%, 43% vs 14% placebo; ≥1-stage fibrosis improvement 34%, 36%, 34% vs 22%.
Study details
Study designRandomized, double-blind, placebo-controlled trial
PhasePhase 2
PopulationAdults with biopsy-confirmed MASH and F1–F3 fibrosis
Sample size293
RouteSubcutaneous
Regimen / exposure2.4, 4.8 or 6.0 mg weekly
Duration48 weeks
ComparatorPlacebo
Primary endpoint / questionMASH improvement without worsening fibrosis
Safety resultNausea 66% vs 23%, diarrhoea 49% vs 23%, vomiting 41% vs 4%; serious AEs 8% vs 7%.
Key limitationsNon-monotonic dose response; fibrosis endpoint less impressive than MASH endpoint; Phase 3 confirmation required.
Registry / identifierNCT04771273