Obicetrapib linked to substantial reductions in LDL cholesterol for high-risk heart patients
Oral obicetrapib, either on its own or paired with ezetimibe, is associated with significant improvements in LDL cholesterol (LDL-C) levels in patients with atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia who are already on lipid-lowering therapy, according to new findings published in two leading medical journals.
Obicetrapib is a highly selective cholesteryl ester transfer protein (CETP) inhibitor developed by NewAmsterdam Pharma. Data from BROADWAY and TANDEM were presented at the European Atherosclerosis Society Congress 2025 and then published in The New England Journal of Medicine and The Lancet, respectively.[1, 2]
BROADWAY included more than 2,500 high-risk patients randomized to either receive daily obicetrapib or a placebo. The mean patient age was 65 years old, 66% of patients were men and the mean baseline LDL-C level was 98 mg/dL.
Overall, by day 84, patients on daily obicetrapib experienced a reduction in LDL-C of 29.9% compared to the increase of 2.7% seen in patients given a placebo. Adverse rates were seen at comparable rates, the authors added, and the composite outcome of coronary heart disease, nonfatal myocardial infarction, stroke and coronary revascularization was seen in 4.2% of obicetrapib patients and 5.2% of placebo patients.
“These findings suggest that obicetrapib may be a useful adjunct to lipid lowering in patients at high risk for cardiovascular events,” wrote first author Stephen J. Nicholls, MBBS, PhD, director of the Monash Victorian Heart Institute and a professor of cardiology at Monash University, and colleagues. “Because treatment goals are not reached in many high-risk patients, despite the use of maximum tolerated doses of statins, and there has been a progressive lowering of the treatment goals, more effective lipid-lowering approaches, such as combination therapies, are increasingly required.”
TANDEM, meanwhile, tracked more than 400 patients randomized to either receive obicetrapib monotherapy, ezetimibe monotherapy, obicetrapib and ezetimibe or a placebo. By day 84, the combination of obicetrapib and ezetimibe was linked to a reduction in LDL-C of 48.6% compared to a placebo. Obicetrapib monotherapy also resulted in a significant reduction, but not as substantial as the one seen when taking both drugs at the same time. Adverse event rates were again similar for the three drug therapy options, but lowest for the placebo group.
“Combination therapy of obicetrapib and ezetimibe significantly reduced LDL cholesterol,” wrote first author Ashish Sarraju, MD, a cardiologist with Cleveland Clinic, and colleagues. “This oral, single-pill therapy could improve LDL cholesterol management in patients with pre-existing or high risk for ASCVD.”
NewAmsterdam Pharma, the company behind obicetrapib, funded both studies.
“These results will support global regulatory filings and reinforce our belief that obicetrapib has the potential to be an effective, once-daily, oral treatment that significantly reduces LDL-C,” Michael Davidson, MD, CEO of NewAmsterdam Pharma, said in a statement.
The full BROADWAY study can be read here. The TANDEM results, meanwhile, can be read here.
Obicetrapib has not yet been approved by the U.S. Food and Drug Administration.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.