BROADWAY: Obicetrapib Significantly Lowers LDL Cholesterol in High-Risk Patients, Global Study Finds
Landmark BROADWAY Trial Published in The New England Journal of Medicine
Landmark BROADWAY Trial Published in The New England Journal of Medicine
The Texas Heart Institute at Baylor College of Medicine News
A new international clinical trial has found that obicetrapib, an investigational CETP inhibitor, significantly lowers low-density lipoprotein (LDL) cholesterol in patients already receiving maximum lipid-lowering therapy. The results of the BROADWAY study, co-authored by Dr. Christie Ballantyne of The Texas Heart Institute at Baylor College of Medicine, were published this month in The New England Journal of Medicine.
The double-blind, placebo-controlled trial included 2,530 patients with atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia. Despite being on statins and other lipid-lowering therapies, these patients remained at elevated cardiovascular risk. Participants were randomized to receive either 10 mg of obicetrapib or placebo once daily for 12 weeks.
Patients treated with obicetrapib experienced a 29.9% reduction in LDL cholesterol at 84 days, compared to a 2.7% increase in the placebo group. Additionally, obicetrapib improved other lipid markers, including apolipoprotein B, non-HDL cholesterol, and lipoprotein(a), while maintaining a favorable safety profile.
“Despite the best available treatments, many patients with heart disease still struggle to get their cholesterol under control,” said Dr. Christie Ballantyne, co-author of the study and Professor of Medicine and Chief of Cardiovascular Research at The Texas Heart Institute at Baylor College of Medicine. “This study shows that obicetrapib could offer an effective new option, especially for those who need additional support beyond statins.”
The BROADWAY trial also found that 51% of patients receiving obicetrapib achieved LDL cholesterol levels below 55 mg/dL, a threshold recommended for very high-risk patients—versus just 8% in the placebo group.
CETP inhibitors have faced challenges in prior trials, but obicetrapib’s high selectivity and favorable pharmacologic profile distinguish it from earlier agents. A long-term cardiovascular outcomes trial is currently underway to determine whether these lipid improvements translate into fewer cardiovascular events.
The study was funded by NewAmsterdam Pharma.
As part of its mission to advance cardiovascular science, The Texas Heart Institute continues to play a key role in translational research that brings promising new therapies to the patients who need them most.
