NewAmsterdam Pharma has completed the enrolment of patients in the Phase III BROADWAY trial of obicetrapib for the treatment of adult patients with heterozygous familial hypercholesterolemia (HeFH) and/or established atherosclerotic cardiovascular disease (ASCVD).
The placebo-controlled, double-blind study intends to assess the safety and tolerability of CETP inhibitor obicetrapib as a monotherapy used as an adjunct to maximally tolerated lipid-lowering therapies.
Nearly 2,500 adult patients, with nearly 100 mg/dL mean baseline LDL-C despite using high-intensity statin, are included in the study.
They are enrolled from eight countries including China, Japan, the Netherlands, and the US. Out of the total participants, 30% are females with a median age of around 66 years.
In the study, patients will be randomised to receive 10mg obicetrapib along with lipid-lowering therapy or placebo once daily with or without food for 52 weeks.
The primary objective of the study is to assess the effect of obicetrapib on lipoprotein cholesterol (LDL-C or LDL) levels at day 84.
The secondary objective of the study features evaluating the impact of the obicetrapib on total cholesterol, non-HDL-C, triglycerides, high-density lipoprotein cholesterol, apolipoprotein B, lipoprotein(a) at day 84 and on LDL-C levels at days 180 and 365.
NewAmsterdam chief scientific officer John Kastelein said: “HeFH and ASCVD can be devastating diseases, which, if inadequately addressed, can result in myocardial infarction, cerebral infarction, or cardiovascular death.
“With obicetrapib, we aim to deliver LDL-C reductions that are substantially better than currently available non-statin oral therapies, in a convenient, tolerable formulation.
“We are pleased to have both BROADWAY and BROOKLYN, the two pivotal Phase III trials necessary to support a potential LDL regulatory filing, fully enrolled and look forward to reporting data from both studies in the second half of 2024.”
A similar Phase III PREVAIL CVOT study was initiated by NewAmsterdam in March last year to evaluate the potential of obicetrapib in reducing MACE occurrences including non-elective coronary revascularisation, non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death.
