Phase 2 trial with CETP inhibitor combined with ezetimibe meets primary endpoint
It was announced that the phase 2 ROSE2 trial met its primary endpoint of percent change in LDL-c. In ROSE2, the combination of obicetrapib and ezetimibe resulted in a median reduction in LDL-c of 59% compared to a reduction of 6% with placebo. The combination of obicetrapib and ezetimibe was well-tolerated with a safety profile comparable to placebo.
ROSE2 was a placebo-controlled, double-blind, randomized, phase 2 trial to evaluate the efficacy, safety and tolerability of obicetrapib 10 mg in combination with ezetimibe 10 mg as an adjunct to high-intensity statin therapy. A total of 119 patients were randomized to combination therapy, obicetrapib 10 mg or placebo for a treatment period of 84 days. Primary efficacy endpoint was the percent change in LDL-c from baseline to day 84.
Full data of the ROSE2 trial is anticipated to be shared in a forthcoming publication or presentation at an upcoming medical meeting.
Based on these results, NewAmsterdam is selecting a formulated fixed-dose combination tablet of obecitrapib and ezetimibe to be tested in a definitive bioequivalence trial and a phase 3 safety and efficacy trial.