NewAmsterdam Pharma Company has concluded enrolment of subjects in the Phase III BROOKYLN clinical trial of obicetrapib to treat heterozygous familial hypercholesterolemia (HeFH).
The pivotal trial will evaluate obicetrapib in adult subjects whose low-density lipoprotein cholesterol (LDL-C) is not adequately controlled, despite receiving maximally tolerated lipid-lowering therapy.
The double-blind, placebo-controlled trial enrolled 354 subjects with a history of HeFH across ten countries in Europe, North America, and Africa.
NewAmsterdam CEO Michael Davidson said: “We believe the rapid enrolment of this study is a reflection of the deep unmet need in the HeFH community for a potent and well-tolerated oral tablet as an adjunct to maximally tolerated statin therapy, especially for this group of patients who spend most of their lives, some from a young age, taking LDL-lowering therapy.
“We would like to thank the principal investigators at clinical trial sites worldwide for their significant contributions, and for their trust and belief in obicetrapib as a new medicine with the potential to improve outcomes for patients living with HeFH whose LDL-C levels are not adequately controlled with standard of care.”
For enrolled patients, the mean baseline LDL-C is >120 mg/dL despite high intensity statin use reported by around 70% of them at the time of screening.
Female participants comprise nearly 53% of the study population and the median age of participants at baseline is 57 years.
The study participants were randomised to receive placebo or 10mg obicetrapib given as a once-a-day oral treatment with or without food for 52 weeks.
Evaluating the effect of obicetrapib on LDL-C levels is the primary objective of the trial, which is also evaluating the safety and tolerability profile.
Secondary objectives include assessing obicetrapib’s effect on non-high-density lipoprotein cholesterol, apolipoprotein B, and lipoprotein.
Topline results from the trial are expected in the second half of next year.