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Human evidence record · Survodutide

SYNCHRONIZE-1: Survodutide once weekly for adults with obesity

At week 76, mean body-weight change was -12.2% with 3.6 mg and -13.0% with 6.0 mg versus -5.4% with placebo; 72.6%, 71.9% and 46.3%, respectively, achieved at least 5% weight reduction.

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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, or overweight with an obesity complication, without diabetes

How many?

n=725

What happened?

At week 76, mean body-weight change was -12.2% with 3.6 mg and -13.0% with 6.0 mg versus -5.4% with placebo; 72.6%, 71.9% and 46.3%, respectively, achieved at least 5% weight reduction.

What stops us overclaiming?

The trial excluded diabetes and lasted 76 weeks; longer-term outcomes and broader population generalisability remain to be established.

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Key result

At week 76, mean body-weight change was -12.2% with 3.6 mg and -13.0% with 6.0 mg versus -5.4% with placebo; 72.6%, 71.9% and 46.3%, respectively, achieved at least 5% weight reduction.

Study details

Study designRandomized, double-blind, placebo-controlled Phase 3 trial
PhasePhase 3
PopulationAdults with obesity, or overweight with an obesity complication, without diabetes
Sample size725
RouteSubcutaneous
Regimen / exposureSurvodutide adjusted to 3.6 mg or 6.0 mg once weekly; placebo
Duration76 weeks
ComparatorPlacebo
Primary endpoint / questionPercentage change in body weight and proportion achieving at least 5% weight reduction
Safety resultGastrointestinal adverse events were most common and were typically mild to moderate; no deaths were reported.
Key limitationsThe trial excluded diabetes and lasted 76 weeks; longer-term outcomes and broader population generalisability remain to be established.
Registry / identifierPMID 42253238 / NCT06066515