Study record · Tirzepatide
SURMOUNT-1 tirzepatide obesity trial
Mean weight change was -15.0%, -19.5% and -20.9% at 5/10/15 mg versus -3.1% with placebo.
Key result
Mean weight change was -15.0%, -19.5% and -20.9% at 5/10/15 mg versus -3.1% with placebo.
Study details
Study designRandomized double-blind placebo-controlled trial
PhasePhase III
PopulationAdults with obesity/overweight without diabetes
Sample size2539
RouteSubcutaneous
Regimen / exposure5, 10 or 15 mg once weekly after dose escalation
Duration72 weeks
ComparatorPlacebo
Primary endpoint / questionPercent body-weight change and >=5% weight loss
Safety resultGastrointestinal adverse events were most common; discontinuation due to AEs was 4.3%, 7.1%, 6.2% and 2.6% for 5/10/15 mg/placebo.
Key limitationsStrong obesity efficacy evidence; results apply to the studied formulation/population and do not validate unverified research products.
Registry / identifierPMID 35658024 / NCT04184622