Human evidence 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.

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/overweight without diabetes

How many?

n=2539

What happened?

Mean weight change was -15.0%, -19.5% and -20.9% at 5/10/15 mg versus -3.1% with placebo.

What stops us overclaiming?

Strong obesity efficacy evidence; results apply to the studied formulation/population and do not validate unverified research products.

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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

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