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Human evidence record · Semaglutide (injectable)

Once-Weekly Semaglutide in Adults with Overweight or Obesity (STEP 1)

Mean weight change -14.9% with semaglutide vs -2.4% placebo; 86.4% achieved ≥5% loss.

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 obesity or qualifying overweight without diabetes

How many?

n=1961

What happened?

Mean weight change -14.9% with semaglutide vs -2.4% placebo; 86.4% achieved ≥5% loss.

What stops us overclaiming?

Trial population excludes diabetes; sponsored trial; long-term maintenance beyond trial required further study.

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Key result

Mean weight change -14.9% with semaglutide vs -2.4% placebo; 86.4% achieved ≥5% loss.

Study details

Study designRandomized, double-blind, placebo-controlled trial
PhasePhase 3
PopulationAdults with obesity or qualifying overweight without diabetes
Sample size1961
RouteSubcutaneous
Regimen / exposure2.4 mg once weekly after escalation + lifestyle
Duration68 weeks
ComparatorPlacebo + lifestyle
Primary endpoint / questionPercent body-weight change and ≥5% weight loss
Safety resultNausea/diarrhoea common; 4.5% discontinued for GI events vs 0.8% placebo.
Key limitationsTrial population excludes diabetes; sponsored trial; long-term maintenance beyond trial required further study.
Registry / identifierNCT03548935