Study record · Cagrilintide
REDEFINE 1 cagrilintide 2.4 mg monotherapy arm
Detailed REDEFINE 1 reporting shows about 11.5% treatment-policy / 11.8% trial-product-estimand weight reduction with cagrilintide 2.4 mg monotherapy versus.
Key result
Detailed REDEFINE 1 reporting shows about 11.5% treatment-policy / 11.8% trial-product-estimand weight reduction with cagrilintide 2.4 mg monotherapy versus about 3.0% / 2.3% placebo.
Study details
Study designRandomized, double-blind, placebo- and active-controlled Phase IIIa trial; monotherapy arm within larger trial
PhasePhase IIIa
PopulationAdults without diabetes with obesity or overweight plus complication
Sample size302 cagrilintide arm
RouteSubcutaneous
Regimen / exposureCagrilintide 2.4 mg once weekly with dose escalation
Duration68 weeks
ComparatorPlacebo; semaglutide; CagriSema arms
Primary endpoint / questionBody-weight change and categorical weight-loss outcomes
Safety resultGI adverse events were common but discontinuation due to GI events was low in the cagrilintide arm.
Key limitationsThe main NEJM paper emphasizes CagriSema; monotherapy values must retain their stated estimand and should not be mixed with combination results.
Registry / identifierNCT05567796