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Human evidence record · Survodutide

SYNCHRONIZE-MASLD: Survodutide in adults with obesity and at-risk MASLD

Using the efficacy estimand, 84.2% of survodutide participants versus 24.3% with placebo achieved at least 30% liver-fat reduction; mean body-weight change was -12.2% versus -1.0%.

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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 obesity and at-risk metabolic dysfunction-associated steatotic liver disease (MASLD)

How many?

n=216

What happened?

Using the efficacy estimand, 84.2% of survodutide participants versus 24.3% with placebo achieved at least 30% liver-fat reduction; mean body-weight change was -12.2% versus -1.0%.

What stops us overclaiming?

48-week duration and recruitment limited to the United States and Spain; findings should not be generalized beyond the studied obesity/MASLD population.

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Key result

Using the efficacy estimand, 84.2% of survodutide participants versus 24.3% with placebo achieved at least 30% liver-fat reduction; mean body-weight change was -12.2% versus -1.0%.

Study details

Study designRandomized, double-blind, placebo-controlled Phase 3 trial
PhasePhase 3
PopulationAdults with obesity and at-risk metabolic dysfunction-associated steatotic liver disease (MASLD)
Sample size216
RouteSubcutaneous
Regimen / exposureSurvodutide 6.0 mg once weekly; placebo
Duration48 weeks
ComparatorPlacebo
Primary endpoint / questionAt least 30% reduction in MRI-PDFF liver fat and percentage body-weight change to week 48
Safety resultGastrointestinal adverse events were most frequent, commonly during dose escalation, and were generally mild to moderate.
Key limitations48-week duration and recruitment limited to the United States and Spain; findings should not be generalized beyond the studied obesity/MASLD population.
Registry / identifierPMID 42252333