Human evidence record · Semaglutide (oral)

OASIS 1 oral semaglutide 50 mg obesity trial

Estimated mean weight change was -15.1% versus -2.4% placebo; 85% versus 26% achieved at least 5% loss.

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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 overweight/obesity without diabetes

How many?

n=667

What happened?

Estimated mean weight change was -15.1% versus -2.4% placebo; 85% versus 26% achieved at least 5% loss.

What stops us overclaiming?

The 50 mg obesity regimen is study-specific and distinct from lower-dose oral semaglutide products/indications.

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Key result

Estimated mean weight change was -15.1% versus -2.4% placebo; 85% versus 26% achieved at least 5% loss.

Study details

Study designRandomized double-blind placebo-controlled trial

PhasePhase III

PopulationAdults with overweight/obesity without diabetes

Sample size667

RouteOral

Regimen / exposureEscalated to 50 mg once daily

Duration68 weeks

ComparatorPlacebo

Primary endpoint / questionPercent body-weight change and >=5% loss

Safety resultGI adverse events occurred in 80% versus 46% with placebo; overall AEs 92% versus 86%.

Key limitationsThe 50 mg obesity regimen is study-specific and distinct from lower-dose oral semaglutide products/indications.

Registry / identifierPMID 37385278 / NCT05035095

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