Study 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.
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