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Human evidence record · Tirzepatide

SURMOUNT-OSA tirzepatide trials

AHI treatment differences versus placebo were about -20.0 events/hour in trial 1 and -23.8 events/hour in trial 2; secondary sleep/cardiometabolic measures also improved.

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 moderate-to-severe OSA and obesity, with and without PAP use

How many?

n=469

What happened?

AHI treatment differences versus placebo were about -20.0 events/hour in trial 1 and -23.8 events/hour in trial 2; secondary sleep/cardiometabolic measures also improved.

What stops us overclaiming?

Population had obesity and moderate-to-severe OSA; results should not be generalized to non-obese sleep disorders.

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Key result

AHI treatment differences versus placebo were about -20.0 events/hour in trial 1 and -23.8 events/hour in trial 2; secondary sleep/cardiometabolic measures also improved.

Study details

Study designTwo randomized double-blind placebo-controlled trials
PhasePhase III
PopulationAdults with moderate-to-severe OSA and obesity, with and without PAP use
Sample size469
RouteSubcutaneous
Regimen / exposureMaximum tolerated tirzepatide 10 or 15 mg once weekly
Duration52 weeks
ComparatorPlacebo
Primary endpoint / questionChange in apnea-hypopnea index
Safety resultMost frequent adverse events were gastrointestinal and mostly mild to moderate.
Key limitationsPopulation had obesity and moderate-to-severe OSA; results should not be generalized to non-obese sleep disorders.
Registry / identifierPMID 38912654 / NCT05412004