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Human evidence 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%.

Quick read
Human evidence record

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.

Who was studied?

Adults with biopsy-confirmed MASH and F1–F3 fibrosis

How many?

n=293

What happened?

Primary response 47%, 62%, 43% vs 14% placebo; ≥1-stage fibrosis improvement 34%, 36%, 34% vs 22%.

What stops us overclaiming?

Non-monotonic dose response; fibrosis endpoint less impressive than MASH endpoint; Phase 3 confirmation required.

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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