Obicetrapib is intended for the treatment of heterozygous familial hypercholesterolemia and atherosclerotic cardiovascular disease. Credit: Crevis/Shutterstock.com.

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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

See Also:

The primary objective of the study is to assess the effect of obicetrapib on lipoprotein cholesterol (LDL-C or LDL) levels at day 84.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.