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Human evidence record ยท Semaglutide (oral)

Oral Semaglutide at a Dose of 25 mg in Adults with Overweight or Obesity

Mean weight change was -13.6% with oral semaglutide versus -2.2% placebo; multiple categorical weight-loss thresholds also favored semaglutide.

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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 plus at least one weight-related complication, without diabetes

How many?

n=307

What happened?

Mean weight change was -13.6% with oral semaglutide versus -2.2% placebo; multiple categorical weight-loss thresholds also favored semaglutide.

What stops us overclaiming?

Formulation/dose-specific obesity trial; do not transfer results to all oral semaglutide products or strengths.

Need help with terms such as randomized, placebo, endpoint or sample size? Open the glossary โ†’

Key result

Mean weight change was -13.6% with oral semaglutide versus -2.2% placebo; multiple categorical weight-loss thresholds also favored semaglutide.

Study details

Study designRandomized, double-blind, placebo-controlled trial
PhasePhase III
PopulationAdults with obesity or overweight plus at least one weight-related complication, without diabetes
Sample size307
RouteOral
Regimen / exposureSemaglutide 25 mg once daily plus lifestyle intervention
Duration64-week efficacy endpoint; 71-week trial
ComparatorPlacebo
Primary endpoint / questionPercent body-weight change and >=5% weight loss
Safety resultGI adverse events occurred in 74.0% versus 42.2% with placebo.
Key limitationsFormulation/dose-specific obesity trial; do not transfer results to all oral semaglutide products or strengths.
Registry / identifierPMID 40934115 / NCT05564117