Study 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.
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