Phase 3 trial with obicetrapib in patients with HeFH meets primary endpoint
The BROOKLYN trial, in which the effect of the CETP inhibitor obicetrapib compared with placebo was evaluated in patients with heterozygous familial hypercholesterolemia (HeFH), met its primary endpoint of LS mean reduction in LDL-c.
The primary endpoint of LS mean reduction in LDL-c with 10 mg obicetrapib at day 84 was met in the phase3 BROOKLYN trial. In this trial, the effect of LDL-c lowering with obicetrapib (on top of maximally tolerated lipid modifying therapies) was evaluated in 354 adult patients with heterozygous familial hypercholesterolemia (HeFH) whose LDL-c was not adequately controlled.
The LS mean reduction in LDL-c compared to placebo was 36.3% (P<0.0001) at day 84, which was sustained at day 365 (LS mean LDL-c reduction was 41.5% (P<0.0001). Other biomarkers including HDL-c, non-HDL-c, Lp(a) and ApoB were significantly changed, consistent with previous data.
In the BROOKLYN trial, obicetrapib was well-tolerated and safety results were comparable to placebo arm and no increase in blood pressure was observed. Treatment discontinuation rate for the obicetrapib arm was 7.6% vs. 14.4% for placebo. The full results will be presented at an upcoming medical conference and published in a medical journal.